Trial Outcomes & Findings for Secondary Prevention of Cardiovascular Disease in the Elderly Trial (NCT NCT02596126)

Last Updated: 2025-05-23

Results Overview

The incidence of the first occurrence of any component of the following composite endpoint, as adjudicated by the Clinical Events Committee: * Cardiovascular death. * Any nonfatal type 1 myocardial infarction. * Any nonfatal ischemic stroke. * Any urgent coronary revascularization not resulting in death.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2499 participants

Primary outcome timeframe

Up to 5 years

Results posted on

2025-05-23

Participant Flow

Patients will be recruited across seven countries in Europe (Spain, Italy, Germany, France, Hungary, Poland, and Czech Republic). Patients were ≥65 years old and diagnosed with a type 1 myocardial infarction within 6 months prior to study enrolment.

Patients can be screened at any time within the first 8 weeks after index event (type 1 myocardial infarction) whenever they are clinically stable and ready to receive secondary prevention therapy, including the hospital phase. Patients with ventricular arrhythmias needing further evaluation of therapy.

Participant milestones

Participant milestones
Measure	Treatment Prevention for Secondary CV Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
Overall Study STARTED	1241	1258
Overall Study COMPLETED	1222	1228
Overall Study NOT COMPLETED	19	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Prevention for Secondary CV Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
Overall Study Lost to Follow-up	12	21
Overall Study Protocol Violation	7	9

Baseline Characteristics

Secondary Prevention of Cardiovascular Disease in the Elderly Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Prevention for Secondary CV n=1229 Participants Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill n=1237 Participants Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).	Total n=2466 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	1229 Participants n=5 Participants	1237 Participants n=7 Participants	2466 Participants n=5 Participants
Sex: Female, Male Female	381 Participants n=5 Participants	384 Participants n=7 Participants	765 Participants n=5 Participants
Sex: Female, Male Male	848 Participants n=5 Participants	853 Participants n=7 Participants	1701 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	1211 Participants n=5 Participants	1221 Participants n=7 Participants	2432 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	18 Participants n=5 Participants	13 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment Hungary	45 participants n=5 Participants	45 participants n=7 Participants	90 participants n=5 Participants
Region of Enrollment Czechia	87 participants n=5 Participants	85 participants n=7 Participants	172 participants n=5 Participants
Region of Enrollment Poland	60 participants n=5 Participants	63 participants n=7 Participants	123 participants n=5 Participants
Region of Enrollment Italy	365 participants n=5 Participants	366 participants n=7 Participants	731 participants n=5 Participants
Region of Enrollment France	70 participants n=5 Participants	74 participants n=7 Participants	144 participants n=5 Participants
Region of Enrollment Germany	184 participants n=5 Participants	182 participants n=7 Participants	366 participants n=5 Participants
Region of Enrollment Spain	418 participants n=5 Participants	422 participants n=7 Participants	840 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome measures
Measure	Treatment Prevention for Secondary CV n=1241 Participants Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill n=1258 Participants Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
Major Cardiovascular Adverse Events (MACE)	156 number of adjudicated events	118 number of adjudicated events

SECONDARY outcome

Timeframe: 6 months

Treatment adherence at 6 months measured using the Morisky-Medication Adherence Scale (8 item) Questionnaire (MMAS-8). Results: Low adherence (0-5); Medium adherence (6-7) and High adherence (8). The number and percentage of patients with low (0-5), medium (6-7) and high (8) adherence will be reported by treatment group.

Outcome measures

Outcome measures
Measure	Treatment Prevention for Secondary CV n=1229 Participants Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill n=1237 Participants Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
Efficacy Endpoints Low adherence (0-5)	9.5 percentage of participants	5.5 percentage of participants
Efficacy Endpoints Medium adherence (6-7)	27.8 percentage of participants	24.0 percentage of participants
Efficacy Endpoints High adherence (8)	62.7 percentage of participants	70.6 percentage of participants

SECONDARY outcome

Timeframe: Up to 5 Years

All-cause mortality.

Outcome measures

Outcome measures
Measure	Treatment Prevention for Secondary CV n=1241 Participants Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill n=1258 Participants Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
Safety Endpoints	117 number of events	115 number of events

SECONDARY outcome

Timeframe: 2 years

Treatment adherence at 24 months measured using the Morisky-Medication Adherence Scale (8 item) Questionnaire (MMAS-8). Results: Low adherence (0-5); Medium adherence (6-7) and High adherence (8). The number and percentage of patients with low (0-5), medium (6-7) and high (8) adherence will be reported by treatment group.

Outcome measures

Outcome measures
Measure	Treatment Prevention for Secondary CV n=1229 Participants Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill n=1237 Participants Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
Efficacy Endpoints Low adherence (0-5)	6.9 percentage of participants	4.2 percentage of participants
Efficacy Endpoints Medium adherence (6-7)	29.8 percentage of participants	21.7 percentage of participants
Efficacy Endpoints High adherence (8)	63.2 percentage of participants	74.1 percentage of participants

SECONDARY outcome

Timeframe: 6 months

The systolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 1 (6 months). Mean and standard deviation will be reported by treatment group.

Outcome measures

Outcome measures
Measure	Treatment Prevention for Secondary CV n=1229 Participants Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill n=1237 Participants Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
Efficacy Endpoints	134.8 millimeters of mercury (mmHg) Standard Deviation 18.1	134.4 millimeters of mercury (mmHg) Standard Deviation 17.7

SECONDARY outcome

Timeframe: 12 months

The systolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 2 (12 months). Mean and standard deviation will be reported by treatment group.

Outcome measures

Outcome measures
Measure	Treatment Prevention for Secondary CV n=1229 Participants Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill n=1237 Participants Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
Efficacy Endpoints	135.0 millimeters of mercury (mmHg) Standard Deviation 18.0	136.3 millimeters of mercury (mmHg) Standard Deviation 17.5

SECONDARY outcome

Timeframe: 2 years

The systolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 3 (24 months). Mean and standard deviation will be reported by treatment group.

Outcome measures

Outcome measures
Measure	Treatment Prevention for Secondary CV n=1229 Participants Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill n=1237 Participants Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
Efficacy Endpoints	135.5 millimeters of mercury (mmHg) Standard Deviation 17.1	135.2 millimeters of mercury (mmHg) Standard Deviation 16.9

SECONDARY outcome

Timeframe: 6 months

The Diastolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 1 (6 months). Mean and standard deviation will be reported by treatment group. The frequency, mean and standard deviation at each visit will be reported by treatment group.

Outcome measures

Outcome measures
Measure	Treatment Prevention for Secondary CV n=1229 Participants Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill n=1237 Participants Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
Efficacy Endpoints	74.2 millimeters of mercury (mmHg) Standard Deviation 9.9	74.3 millimeters of mercury (mmHg) Standard Deviation 10.2

SECONDARY outcome

Timeframe: 12 months

The Diastolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 2 (12 months). Mean and standard deviation will be reported by treatment group. The frequency, mean and standard deviation at each visit will be reported by treatment group.

Outcome measures

Outcome measures
Measure	Treatment Prevention for Secondary CV n=1229 Participants Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill n=1237 Participants Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
Efficacy Endpoints	74.1 millimeters of mercury (mmHg) Standard Deviation 9.8	74.7 millimeters of mercury (mmHg) Standard Deviation 9.9

SECONDARY outcome

Timeframe: 2 years

The Diastolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 3 (24 months). Mean and standard deviation will be reported by treatment group. The frequency, mean and standard deviation at each visit will be reported by treatment group.

Outcome measures

Outcome measures
Measure	Treatment Prevention for Secondary CV n=1229 Participants Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill n=1237 Participants Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
Efficacy Endpoints	74.9 millimeters of mercury (mmHg) Standard Deviation 9.7	74.8 millimeters of mercury (mmHg) Standard Deviation 10.1

SECONDARY outcome

Timeframe: 12 months

Low-density lipoprotein (LDL) cholesterol levels measured in mg/dL at visit 2 (12 months). Mean and standard deviation will be reported by treatment group. The frequency, mean and standard deviation at each visit will be reported by treatment group.

Outcome measures

Outcome measures
Measure	Treatment Prevention for Secondary CV n=1229 Participants Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill n=1237 Participants Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
Efficacy Endpoints	66.3 mg/dL Standard Deviation 25.4	69.2 mg/dL Standard Deviation 24.7

SECONDARY outcome

Timeframe: 2 years

Low-density lipoprotein (LDL) cholesterol levels measured in mg/dL at visit 3 (24 months). Mean and standard deviation will be reported by treatment group. The frequency, mean and standard deviation at each visit will be reported by treatment group.

Outcome measures

Outcome measures
Measure	Treatment Prevention for Secondary CV n=1229 Participants Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill n=1237 Participants Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
Efficacy Endpoints	67.2 mg/dL Standard Deviation 25.4	67.7 mg/dL Standard Deviation 23.6

SECONDARY outcome

Timeframe: Up to 5 years

The incidence of the first occurrence of any component of the following composite endpoint, as adjudicated by the Clinical Events Committee: Cardiovascular death (CV death); Acute Myocardial Infarction (MI) type 1; stroke. Measured in number of cases.

Outcome measures

Outcome measures
Measure	Treatment Prevention for Secondary CV n=1241 Participants Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill n=1258 Participants Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
Efficacy Endpoints	144 number of events	101 number of events

SECONDARY outcome

Timeframe: Up to 5 years

The incidence of the first occurrence of the Cardiovascular (CV) death. Measured in number of cases.

Outcome measures

Outcome measures
Measure	Treatment Prevention for Secondary CV n=1241 Participants Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill n=1258 Participants Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
Efficacy Endpoints	71 number of events	48 number of events

SECONDARY outcome

Timeframe: Up to 5 years

The incidence of the first occurrence of of the Nonfatal type 1 myocardial infarction. Measured in number of cases.

Outcome measures

Outcome measures
Measure	Treatment Prevention for Secondary CV n=1241 Participants Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill n=1258 Participants Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
Efficacy Endpoints	62 number of events	44 number of events

SECONDARY outcome

Timeframe: Up to 5 years

The incidence of the first occurrence of the Nonfatal ischemic stroke. Measured in number of cases.

Outcome measures

Outcome measures
Measure	Treatment Prevention for Secondary CV n=1241 Participants Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill n=1258 Participants Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
Efficacy Endpoints	27 number of events	19 number of events

SECONDARY outcome

Timeframe: Up to 5 years

The incidence of the first occurrence of the Urgent coronary revascularization. Measured in number of cases.

Outcome measures

Outcome measures
Measure	Treatment Prevention for Secondary CV n=1241 Participants Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill n=1258 Participants Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
Efficacy Endpoints	28 number of events	27 number of events

SECONDARY outcome

Timeframe: 6 months

Domain "effectiveness" of the Patient satisfaction measured at visit 1 (6 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM (version 1.4) has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain (effectiveness) the response was measured on a Likert-type scale of 5 or 7 points. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction (higher scores reflect higher patient satisfaction with medication).

Outcome measures

Outcome measures
Measure	Treatment Prevention for Secondary CV n=1229 Participants Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill n=1237 Participants Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
Efficacy Endpoints	69.17 score on a scale Standard Deviation 17.57	72.26 score on a scale Standard Deviation 17.85

SECONDARY outcome

Timeframe: 6 months

Domain "Side effects score" of the Patient satisfaction measured at visit 1 (6 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain the response was on a Likert-type scale of 5 or 7 points, except for question 4 which a yes/no question about the presence of side effects is asked. If the answer to this question is no (no side effects reported by the participant), other questions will not be asked (questions 5 to 8), and the total score is automatically computed as the maximum of 100. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction.

Outcome measures

Outcome measures
Measure	Treatment Prevention for Secondary CV n=1229 Participants Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill n=1237 Participants Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
Efficacy Endpoints	66.71 score on a scale Standard Deviation 23.38	61.52 score on a scale Standard Deviation 23.18

SECONDARY outcome

Timeframe: 6 months

Domain "Convenience score" of the Patient satisfaction measured at visit 1 (6 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM (version 1.4) has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain (Convenience score) the response was measured on a Likert-type scale of 5 or 7 points. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction (higher scores reflect higher patient satisfaction with medication).

Outcome measures

Outcome measures
Measure	Treatment Prevention for Secondary CV n=1229 Participants Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill n=1237 Participants Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
Efficacy Endpoints	69.47 score on a scale Standard Deviation 16.87	76.56 score on a scale Standard Deviation 14.78

SECONDARY outcome

Timeframe: 6 months

Domain "Global satisfaction score" of the Patient satisfaction measured at visit 1 (6 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM (version 1.4) has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain (Global satisfaction score) the response was measured on a Likert-type scale of 5 or 7 points. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction (higher scores reflect higher patient satisfaction with medication).

Outcome measures

Outcome measures
Measure	Treatment Prevention for Secondary CV n=1229 Participants Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill n=1237 Participants Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
Efficacy Endpoints	67.71 score on a scale Standard Deviation 18.53	71.50 score on a scale Standard Deviation 18.06

SECONDARY outcome

Timeframe: 24 months

Domain "effectiveness" of the Patient satisfaction measured at visit 3 (24 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM (version 1.4) has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain (effectiveness) the response was measured on a Likert-type scale of 5 or 7 points. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction (higher scores reflect higher patient satisfaction with medication).

Outcome measures

Outcome measures
Measure	Treatment Prevention for Secondary CV n=1229 Participants Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill n=1237 Participants Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
Efficacy Endpoints	68.79 score on a scale Standard Deviation 17.65	74.06 score on a scale Standard Deviation 17.86

SECONDARY outcome

Timeframe: 24 months

Domain "Side effects score" of the Patient satisfaction measured at visit 3 (24 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain (Side effects score) the response was on a Likert-type scale of 5 or 7 points, except for question 4 which a yes/no question about the presence of side effects is asked. If the answer to this question is no (no side effects reported by the participant), other questions will not be asked (questions 5 to 8), and the total score is automatically computed as the maximum of 100. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction.

Outcome measures

Outcome measures
Measure	Treatment Prevention for Secondary CV n=1229 Participants Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill n=1237 Participants Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
Efficacy Endpoints	64.20 score on a scale Standard Deviation 23.14	68.75 score on a scale Standard Deviation 24.83

SECONDARY outcome

Timeframe: 24 months

Domain "Convenience score" of the Patient satisfaction measured at visit 3 (24 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM (version 1.4) has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain (Convenience score) the response was measured on a Likert-type scale of 5 or 7 points. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction (higher scores reflect higher patient satisfaction with medication).

Outcome measures

Outcome measures
Measure	Treatment Prevention for Secondary CV n=1229 Participants Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill n=1237 Participants Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
Efficacy Endpoints	70.19 score on a scale Standard Deviation 17.06	77.30 score on a scale Standard Deviation 15.95

SECONDARY outcome

Timeframe: 24 months

Domain "Global satisfaction score" of the Patient satisfaction measured at visit 3 (24 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM (version 1.4) has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain (Global satisfaction score) the response was measured on a Likert-type scale of 5 or 7 points. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction (higher scores reflect higher patient satisfaction with medication).

Outcome measures

Outcome measures
Measure	Treatment Prevention for Secondary CV n=1229 Participants Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill n=1237 Participants Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
Efficacy Endpoints	67.76 score on a scale Standard Deviation 17.87	74.36 score on a scale Standard Deviation 17.52

SECONDARY outcome

Timeframe: Up to 5 Years

The incidence of the first occurrence of the Non-cardiovascular death. Measured in number of cases.

Outcome measures

Outcome measures
Measure	Treatment Prevention for Secondary CV n=1241 Participants Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill n=1258 Participants Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
Safety Endpoints	46 number of events	67 number of events

Adverse Events

Treatment Prevention for Secondary CV

Serious events: 220 serious events

Other events: 388 other events

Deaths: 117 deaths

Cardiovascular Polypill

Serious events: 248 serious events

Other events: 404 other events

Deaths: 115 deaths

Serious adverse events

Other adverse events

Additional Information

Antonio J Quesada, PhD

Centro Nacional de Investigaciones Cardiovasculares Carlos III F.S.P (CNIC)

Phone: +34 914531200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Treatment Prevention for Secondary CV n=1229 participants at risk Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill n=1237 participants at risk Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) metastasis	0.00% 0/1229 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Injury, poisoning and procedural complications multiple fractures	0.00% 0/1229 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.16% 2/1237 • Number of events 2 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Neoplasms benign, malignant and unspecified (incl cysts and polyps) metastatic gastric cancer	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.00% 0/1237 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Gastrointestinal disorders abdominal pain	0.00% 0/1229 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Infections and infestations abscess	0.00% 0/1229 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Surgical and medical procedures abscess drainage	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.00% 0/1237 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Vascular disorders accelerated hypertension	0.00% 0/1229 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Hepatobiliary disorders acute cholecystitis	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.00% 0/1237 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Cardiac disorders acute coronary syndrome	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 2 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Cardiac disorders acute heart failure	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.00% 0/1237 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Renal and urinary disorders acute kidney failure	0.00% 0/1229 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Renal and urinary disorders acute kidney injury	0.73% 9/1229 • Number of events 9 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.73% 9/1237 • Number of events 9 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Respiratory, thoracic and mediastinal disorders acute pulmonary oedema	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Respiratory, thoracic and mediastinal disorders acute respiratory distress syndrome	0.00% 0/1229 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Respiratory, thoracic and mediastinal disorders acute respiratory failure	0.16% 2/1229 • Number of events 2 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.00% 0/1237 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Neoplasms benign, malignant and unspecified (incl cysts and polyps) adenocarcinoma	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.00% 0/1237 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Neoplasms benign, malignant and unspecified (incl cysts and polyps) adenocarcinoma of colon	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.00% 0/1237 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
General disorders adverse drug reaction	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.00% 0/1237 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Immune system disorders allergy to arthropod sting	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.00% 0/1237 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Blood and lymphatic system disorders anaemia	0.73% 9/1229 • Number of events 10 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.81% 10/1237 • Number of events 10 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Cardiac disorders angina pectoris	0.16% 2/1229 • Number of events 3 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.24% 3/1237 • Number of events 3 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Cardiac disorders angina unstable	0.16% 2/1229 • Number of events 2 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Skin and subcutaneous tissue disorders angioedema	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.00% 0/1237 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Musculoskeletal and connective tissue disorders arthralgia	0.00% 0/1229 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Musculoskeletal and connective tissue disorders arthritis	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.00% 0/1237 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
General disorders asthenia	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.00% 0/1237 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Cardiac disorders atrial fibrillation	0.16% 2/1229 • Number of events 2 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.00% 0/1237 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Cardiac disorders atrioventricular block complete	0.00% 0/1229 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.16% 2/1237 • Number of events 2 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Musculoskeletal and connective tissue disorders back pain	0.16% 2/1229 • Number of events 2 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.24% 3/1237 • Number of events 3 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Infections and infestations bacteraemia	0.16% 2/1229 • Number of events 3 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.16% 2/1237 • Number of events 2 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Neoplasms benign, malignant and unspecified (incl cysts and polyps) benign gastric neoplasm	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.00% 0/1237 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Neoplasms benign, malignant and unspecified (incl cysts and polyps) benign neoplasm of testis	0.00% 0/1229 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Reproductive system and breast disorders benign prostatic hyperplasia	0.00% 0/1229 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Hepatobiliary disorders biliary obstruction	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Infections and infestations biliary sepsis	0.00% 0/1229 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Neoplasms benign, malignant and unspecified (incl cysts and polyps) bladder cancer	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.16% 2/1237 • Number of events 2 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Neoplasms benign, malignant and unspecified (incl cysts and polyps) bladder cancer recurrent	0.00% 0/1229 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Investigations blood creatine phosphokinase increased	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.00% 0/1237 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Neoplasms benign, malignant and unspecified (incl cysts and polyps) bone cancer	0.00% 0/1229 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Musculoskeletal and connective tissue disorders bone pain	0.00% 0/1229 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities

Other adverse events
Measure	Treatment Prevention for Secondary CV n=1229 participants at risk Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	Cardiovascular Polypill n=1237 participants at risk Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
General disorders Chest pain	2.3% 28/1229 • Number of events 31 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	1.3% 16/1237 • Number of events 20 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
General disorders Discomfort	0.16% 2/1229 • Number of events 2 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.00% 0/1237 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
General disorders Drug intolerance	0.16% 2/1229 • Number of events 3 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.32% 4/1237 • Number of events 4 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
General disorders Drug therapeutic incompatibility	0.00% 0/1229 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Gastrointestinal disorders Rectal haemorrhage	0.16% 2/1229 • Number of events 2 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.16% 2/1237 • Number of events 3 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Gastrointestinal disorders Tongue oedema	0.00% 0/1229 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 2 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Gastrointestinal disorders Umbilical hernia	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.16% 2/1237 • Number of events 3 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
General disorders Asthenia	0.16% 2/1229 • Number of events 2 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.40% 5/1237 • Number of events 5 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
General disorders Chest discomfort	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/1229 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Gastrointestinal disorders Vomiting	0.49% 6/1229 • Number of events 7 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.32% 4/1237 • Number of events 4 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
General disorders Adverse event	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.00% 0/1237 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Blood and lymphatic system disorders Anaemia	1.1% 13/1229 • Number of events 14 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.97% 12/1237 • Number of events 13 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Blood and lymphatic system disorders Anaemia macrocytic	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.00% 0/1237 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Blood and lymphatic system disorders Eosinophilia	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.00% 0/1237 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Blood and lymphatic system disorders Iron deficiency anaemia	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.16% 2/1237 • Number of events 2 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Blood and lymphatic system disorders Leukocytosis	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.00% 0/1237 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Blood and lymphatic system disorders Leukopenia	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.00% 0/1237 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Blood and lymphatic system disorders Splenic infarction	0.00% 0/1229 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/1229 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Cardiac disorders Acute coronary syndrome	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Cardiac disorders Angina pectoris	0.73% 9/1229 • Number of events 11 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.65% 8/1237 • Number of events 8 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Cardiac disorders Angina unstable	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.00% 0/1237 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Cardiac disorders Atrial fibrillation	1.5% 19/1229 • Number of events 20 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	1.3% 16/1237 • Number of events 19 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Cardiac disorders Atrial flutter	0.24% 3/1229 • Number of events 3 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.16% 2/1237 • Number of events 2 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Cardiac disorders Atrial tachycardia	0.00% 0/1229 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Cardiac disorders Atrioventricular block	0.00% 0/1229 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Cardiac disorders Atrioventricular block first degree	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.00% 0/1237 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Cardiac disorders Atrioventricular block second degree	0.00% 0/1229 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Cardiac disorders Bradycardia	0.24% 3/1229 • Number of events 3 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.32% 4/1237 • Number of events 4 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Cardiac disorders Bundle branch block left	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.00% 0/1237 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Cardiac disorders Cardiac disorder	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.00% 0/1237 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Cardiac disorders Cardiac failure	0.33% 4/1229 • Number of events 4 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.57% 7/1237 • Number of events 8 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Cardiac disorders Cardiac failure acute	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Cardiac disorders Cardiac failure congestive	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 2 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Cardiac disorders Cardiac ventricular thrombosis	0.00% 0/1229 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Cardiac disorders Coronary artery aneurysm	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.00% 0/1237 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Cardiac disorders Coronary ostial stenosis	0.00% 0/1229 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Cardiac disorders Extrasystoles	0.08% 1/1229 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.00% 0/1237 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities
Cardiac disorders Mitral valve disease	0.00% 0/1229 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities	0.08% 1/1237 • Number of events 1 • Up to 5 Years. Aspirin, Atorvastatin, and Ramipril have been extensively studied in Phase 1 through Phase 4 clinical studies and their overall safety profile has been well characterized. Thus, appropriate information concerning adverse events were systematically collected and submitted to regulatory authorities