Trial Outcomes & Findings for Polypill For Prevention of Cardiovascular Disease (NCT NCT00567307)
NCT ID: NCT00567307
Last Updated: 2018-09-10
Results Overview
Estimated 10-year CVD total risk score were calculated in the field centers and in the Coordinating Center from the measures of blood pressure and total cholesterol and from the medical history data collected during each visit using the WHO CVD prediction chart. The estimated 10-year CVD total risk calculated by the Coordinating Center were used for analysis. the score is based on systolic blood pressure and total cholesterol measures as well as on medical history data (monthly). Each one of these risk factors is assigned a point in the score and then linked to a table that mention the calculated CVD risk
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
216 participants
Primary outcome timeframe
Six months
Results posted on
2018-09-10
Participant Flow
Participant milestones
| Measure |
The Polypill Group (Arm A)
The Polypill Group (Arm A) received a Polypill composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide
Red Heart Pill 2b (Polypill): Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)
|
Standard Practice Group (Arm B)
Standard Practice
Standard Practice: Arm B received management of their CVD risk according to the usual care given to participants in similar conditions
|
|---|---|---|
|
Overall Study
STARTED
|
111
|
105
|
|
Overall Study
COMPLETED
|
99
|
104
|
|
Overall Study
NOT COMPLETED
|
12
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Polypill For Prevention of Cardiovascular Disease
Baseline characteristics by cohort
| Measure |
The Polypill Group (Arm A)
n=111 Participants
The Polypill Group (Arm A) received a Polypill composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide
Red Heart Pill 2b (Polypill): Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)
|
Standard Practice Group (Arm B)
n=105 Participants
Standard Practice
Standard Practice: Arm B received management of their CVD risk according to the usual care given to participants in similar conditions
|
Total
n=216 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.2 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
59.0 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
59.1 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Systolic Blood Pressure
|
164.7 mmHG
STANDARD_DEVIATION 17.3 • n=5 Participants
|
165.7 mmHG
STANDARD_DEVIATION 19.2 • n=7 Participants
|
165.2 mmHG
STANDARD_DEVIATION 18.2 • n=5 Participants
|
|
Total Cholesterol
|
5.7 mmol/L
STANDARD_DEVIATION 1.3 • n=5 Participants
|
6.1 mmol/L
STANDARD_DEVIATION 1.3 • n=7 Participants
|
5.9 mmol/L
STANDARD_DEVIATION 1.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Six monthsEstimated 10-year CVD total risk score were calculated in the field centers and in the Coordinating Center from the measures of blood pressure and total cholesterol and from the medical history data collected during each visit using the WHO CVD prediction chart. The estimated 10-year CVD total risk calculated by the Coordinating Center were used for analysis. the score is based on systolic blood pressure and total cholesterol measures as well as on medical history data (monthly). Each one of these risk factors is assigned a point in the score and then linked to a table that mention the calculated CVD risk
Outcome measures
| Measure |
The Polypill Group (Arm A)
n=99 Participants
The Polypill Group (Arm A) received a Polypill composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide
Red Heart Pill 2b (Polypill): Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)
|
Standard Practice Group (Arm B)
n=104 Participants
Standard Practice
Standard Practice: Arm B received management of their CVD risk according to the usual care given to participants in similar conditions
|
|---|---|---|
|
Reduction of the Estimated 10-year Total Cardiovascular Risk Score
|
11.5 percent
Standard Deviation 113.0
|
11.1 percent
Standard Deviation 10
|
Adverse Events
The Polypill Group (Arm A)
Serious events: 26 serious events
Other events: 15 other events
Deaths: 0 deaths
Standard Practice Group (Arm B)
Serious events: 29 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
The Polypill Group (Arm A)
n=99 participants at risk
The Polypill Group (Arm A) received a Polypill composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide
Red Heart Pill 2b (Polypill): Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)
|
Standard Practice Group (Arm B)
n=104 participants at risk
Standard Practice
Standard Practice: Arm B received management of their CVD risk according to the usual care given to participants in similar conditions
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
26.3%
26/99 • Number of events 26 • Cumulative frequency of major side effects during the 3-month treatment period by study group among those who completed the study (99 in the polypill group and 104 in the standard practice)
This is among those who completed the study (99 in the polypill group and 104 in the standard practice)
|
27.9%
29/104 • Number of events 29 • Cumulative frequency of major side effects during the 3-month treatment period by study group among those who completed the study (99 in the polypill group and 104 in the standard practice)
This is among those who completed the study (99 in the polypill group and 104 in the standard practice)
|
|
Gastrointestinal disorders
Epigastric pain
|
15.2%
15/99 • Number of events 15 • Cumulative frequency of major side effects during the 3-month treatment period by study group among those who completed the study (99 in the polypill group and 104 in the standard practice)
This is among those who completed the study (99 in the polypill group and 104 in the standard practice)
|
19.2%
20/104 • Number of events 20 • Cumulative frequency of major side effects during the 3-month treatment period by study group among those who completed the study (99 in the polypill group and 104 in the standard practice)
This is among those who completed the study (99 in the polypill group and 104 in the standard practice)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.3%
25/99 • Number of events 25 • Cumulative frequency of major side effects during the 3-month treatment period by study group among those who completed the study (99 in the polypill group and 104 in the standard practice)
This is among those who completed the study (99 in the polypill group and 104 in the standard practice)
|
17.3%
18/104 • Number of events 18 • Cumulative frequency of major side effects during the 3-month treatment period by study group among those who completed the study (99 in the polypill group and 104 in the standard practice)
This is among those who completed the study (99 in the polypill group and 104 in the standard practice)
|
Other adverse events
| Measure |
The Polypill Group (Arm A)
n=99 participants at risk
The Polypill Group (Arm A) received a Polypill composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide
Red Heart Pill 2b (Polypill): Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)
|
Standard Practice Group (Arm B)
n=104 participants at risk
Standard Practice
Standard Practice: Arm B received management of their CVD risk according to the usual care given to participants in similar conditions
|
|---|---|---|
|
General disorders
Fatigue
|
15.2%
15/99 • Number of events 15 • Cumulative frequency of major side effects during the 3-month treatment period by study group among those who completed the study (99 in the polypill group and 104 in the standard practice)
This is among those who completed the study (99 in the polypill group and 104 in the standard practice)
|
11.5%
12/104 • Number of events 12 • Cumulative frequency of major side effects during the 3-month treatment period by study group among those who completed the study (99 in the polypill group and 104 in the standard practice)
This is among those who completed the study (99 in the polypill group and 104 in the standard practice)
|
Additional Information
Dr. Elsayed Z Soliman, Director of the Epidemiological Cardiology Research Center
Wake Forest School of Medicine, Winston Salem, NC
Phone: 336-716-8632
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place