Trial Outcomes & Findings for Atorvastatin Pre-Treatment Study In Asian Patients With Acute Coronary Syndrome (NCT NCT00728988)

Last Updated: 2021-02-21

Results Overview

Percentage calculated as: (number of participants who experienced MACE \[death, myocardial infarction, target vessel revascularization\] within 30 days post-PCI) divided by (number of participants who experienced PCI) \* 100. Major Adverse Cardiac Events (MACE) that occurred after 33 days post PCI were excluded.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

499 participants

Primary outcome timeframe

30 days post PCI

Results posted on

2021-02-21

Participant Flow

Participant milestones

Participant milestones
Measure	Atorvastatin Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.	Usual Care Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
Overall Study STARTED	247	252
Overall Study Treated	245	250
Overall Study Full Analysis Set	163	172
Overall Study COMPLETED	154	164
Overall Study NOT COMPLETED	93	88

Reasons for withdrawal

Reasons for withdrawal
Measure	Atorvastatin Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.	Usual Care Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
Overall Study Not Treated	2	2
Overall Study Death	1	1
Overall Study Adverse Event	3	2
Overall Study Other	85	77
Overall Study Withdrawal by Subject	2	6

Baseline Characteristics

Atorvastatin Pre-Treatment Study In Asian Patients With Acute Coronary Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Atorvastatin n=247 Participants Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.	Usual Care n=252 Participants Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.	Total n=499 Participants Total of all reporting groups
Age, Customized 18 to 44 years	23 participants n=5 Participants	9 participants n=7 Participants	32 participants n=5 Participants
Age, Customized 45 to 64 years	134 participants n=5 Participants	156 participants n=7 Participants	290 participants n=5 Participants
Age, Customized >= 65 years	90 participants n=5 Participants	87 participants n=7 Participants	177 participants n=5 Participants
Sex: Female, Male Female	81 Participants n=5 Participants	77 Participants n=7 Participants	158 Participants n=5 Participants
Sex: Female, Male Male	166 Participants n=5 Participants	175 Participants n=7 Participants	341 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days post PCI

Population: Full Analysis Set (FAS): all participants who received at least one dose of study medication and received percutaneous coronary intervention (PCI). Last observation carried forward (LOCF).

Outcome measures

Outcome measures
Measure	Atorvastatin n=163 Participants Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.	Usual Care n=172 Participants Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 30 Days Post-percutaneous Coronary Intervention (PCI) Total MACE	14.7 percentage of participants	15.7 percentage of participants
Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 30 Days Post-percutaneous Coronary Intervention (PCI) Death	0.6 percentage of participants	0.6 percentage of participants
Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 30 Days Post-percutaneous Coronary Intervention (PCI) Myocardial Infarction	14.1 percentage of participants	15.1 percentage of participants
Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 30 Days Post-percutaneous Coronary Intervention (PCI) Target Vessel Revascularization	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: 8 hours post PCI

Population: FAS.

Percentage calculated as: (number of participants who experienced MACE within 8 hours post-PCI) divided by (number of participants who experienced PCI) \* 100.

Outcome measures

Outcome measures
Measure	Atorvastatin n=163 Participants Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.	Usual Care n=172 Participants Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 8 Hours Post-PCI	6.7 percentage of participants	6.4 percentage of participants

SECONDARY outcome

Timeframe: 24 hours post PCI

Population: FAS.

Percentage calculated as: (number of participants who experienced MACE within 24 hours post PCI) divided by (number of participants who experienced PCI) \* 100.

Outcome measures

Outcome measures
Measure	Atorvastatin n=163 Participants Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.	Usual Care n=172 Participants Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 24 Hours Post-PCI	13.5 percentage of participants	15.1 percentage of participants

SECONDARY outcome

Timeframe: 8 hours, 24 hours and 30 days post PCI

Population: FAS. N = number of participants with baseline and at least one post-baseline response.

CK-MB above the upper limit of normal range from baseline (biomarker of myocardial injury); normal range: 0-5.0 nanograms per milliliter (ng/mL).

Outcome measures

Outcome measures
Measure	Atorvastatin n=160 Participants Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.	Usual Care n=169 Participants Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
Percentage of Participants With Elevated Creatine Kinase-MB (CK-MB) 8 Hours Post-PCI	11.3 percentage of participants	13.6 percentage of participants
Percentage of Participants With Elevated Creatine Kinase-MB (CK-MB) 24 Hours Post-PCI	15.6 percentage of participants	18.9 percentage of participants
Percentage of Participants With Elevated Creatine Kinase-MB (CK-MB) 30 Days Post-PCI	1.3 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: 8 hours, 24 hours and 30 days post PCI

Population: FAS. N = number of participants with baseline and at least one post-baseline response.

Troponin I above the upper limit of normal range from baseline (biomarker of myocardial injury): normal range: 0-0.5 nanograms per milliliter (ng/mL).

Outcome measures

Outcome measures
Measure	Atorvastatin n=161 Participants Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.	Usual Care n=169 Participants Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
Percentage of Participants With Elevated Troponin I 8 hours post-PCI	40.4 percentage of participants	35.5 percentage of participants
Percentage of Participants With Elevated Troponin I 24 hours post-PCI	49.7 percentage of participants	44.4 percentage of participants
Percentage of Participants With Elevated Troponin I 30 days post-PCI	1.9 percentage of participants	1.8 percentage of participants

SECONDARY outcome

Timeframe: 8 hours, 24 hours and 30 days post PCI

Population: FAS. N = number of participants with baseline and at least one post-baseline response.

Myoglobin above the upper limit of normal from baseline (biomarker of myocardial injury): normal range: 0-109 nanograms per milliliter (ng/mL).

Outcome measures

Outcome measures
Measure	Atorvastatin n=159 Participants Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.	Usual Care n=166 Participants Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
Percentage of Participants With Elevated Myoglobin 8 hours post-PCI	8.2 percentage of participants	10.8 percentage of participants
Percentage of Participants With Elevated Myoglobin 24 hours post-PCI	3.1 percentage of participants	4.2 percentage of participants
Percentage of Participants With Elevated Myoglobin 30 days post-PCI	1.3 percentage of participants	0.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline, 8 hours, 24 hours and 30 days

Population: FAS. N = number of subjects with non-missing values at baseline.

C-reactive protein percent change from baseline = (post baseline value minus baseline value) divided by baseline value\*100. Includes all CRP samples tested for the study, including samples unaffected and those samples affected by defective high-sensitivity (hs) CRP reagents.

Outcome measures

Outcome measures
Measure	Atorvastatin n=161 Participants Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.	Usual Care n=169 Participants Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
Percent Change From Baseline in C-Reactive Protein (CRP) 8 hours post-PCI	205.25 percent change in CRP Standard Error 67.799	234.77 percent change in CRP Standard Error 66.135
Percent Change From Baseline in C-Reactive Protein (CRP) 24 hours post-PCI	594.07 percent change in CRP Standard Error 110.774	543.50 percent change in CRP Standard Error 107.730
Percent Change From Baseline in C-Reactive Protein (CRP) 30 days post-PCI	9.01 percent change in CRP Standard Error 58.276	67.23 percent change in CRP Standard Error 56.562

Adverse Events

Atorvastatin

Serious events: 16 serious events

Other events: 65 other events

Deaths: 0 deaths

Usual Care

Serious events: 16 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Atorvastatin n=245 participants at risk Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.	Usual Care n=250 participants at risk Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
Cardiac disorders Myocardial infarction	6.1% 15/245 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.	4.8% 12/250 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.
General disorders Chest pain	5.3% 13/245 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.	4.4% 11/250 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.
Musculoskeletal and connective tissue disorders Back pain	5.7% 14/245 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.	2.8% 7/250 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.
Nervous system disorders Headache	11.8% 29/245 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.	7.2% 18/250 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Measure	Atorvastatin n=245 participants at risk Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.	Usual Care n=250 participants at risk Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
Cardiac disorders Acute myocardial infarction	0.41% 1/245 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.	0.00% 0/250 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.
Cardiac disorders Angina unstable	0.00% 0/245 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.	0.40% 1/250 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.
Cardiac disorders Atrial fibrillation	0.41% 1/245 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.	0.00% 0/250 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.
Cardiac disorders Myocardial infarction	1.2% 3/245 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.	1.6% 4/250 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.
Cardiac disorders Palpitations	0.41% 1/245 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.	0.00% 0/250 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.
Eye disorders Visual impairment	0.41% 1/245 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.	0.00% 0/250 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.
Gastrointestinal disorders Gastritis	0.41% 1/245 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.	0.00% 0/250 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.
Gastrointestinal disorders Gastritis erosive	0.41% 1/245 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.	0.00% 0/250 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.
General disorders Chest discomfort	0.00% 0/245 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.	0.40% 1/250 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.
General disorders Chest pain	0.41% 1/245 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.	0.40% 1/250 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.
General disorders Death	0.41% 1/245 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.	0.00% 0/250 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.
Hepatobiliary disorders Hepatitis acute	0.41% 1/245 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.	0.00% 0/250 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.
Injury, poisoning and procedural complications Post procedural myocardial infarction	1.6% 4/245 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.	2.8% 7/250 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.
Investigations Alanine aminotransferase increased	0.00% 0/245 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.	0.40% 1/250 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.
Nervous system disorders Cerebral infarction	0.41% 1/245 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.	0.00% 0/250 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.
Nervous system disorders Cerebrovascular accident	0.00% 0/245 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.	0.40% 1/250 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.41% 1/245 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.	0.00% 0/250 Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.