Trial Outcomes & Findings for A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects (NCT NCT00699998)

Last Updated: 2013-05-07

Results Overview

The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

9326 participants

Primary outcome timeframe

Randomization through end of study (30-month visit)

Results posted on

2013-05-07

Participant Flow

Participant milestones

Participant milestones
Measure	Prasugrel: <75 Years of Age Prasugrel and Low-dose Commercially-available Aspirin in participants less than (\<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.	Prasugrel: 75 Years of Age or Older Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.	Clopidogrel: <75 Years of Age Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (\<) 75 years of age. Commercially-available Aspirin : Low-dose aspirin, oral, as prescribed by physician through end of study Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study	Clopidogrel: 75 Years of Age or Older Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
Overall Study STARTED	3620	1043	3623	1040
Overall Study Received at Least 1 Dose of Study Drug	3590	1033	3590	1027
Overall Study COMPLETED	3421	957	3417	958
Overall Study NOT COMPLETED	199	86	206	82

Reasons for withdrawal

Reasons for withdrawal
Measure	Prasugrel: <75 Years of Age Prasugrel and Low-dose Commercially-available Aspirin in participants less than (\<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.	Prasugrel: 75 Years of Age or Older Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.	Clopidogrel: <75 Years of Age Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (\<) 75 years of age. Commercially-available Aspirin : Low-dose aspirin, oral, as prescribed by physician through end of study Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study	Clopidogrel: 75 Years of Age or Older Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
Overall Study Withdrawal by Subject	194	83	202	80
Overall Study Physician Decision	3	2	1	1
Overall Study Lost to Follow-up	2	1	3	1

Baseline Characteristics

A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prasugrel: <75 Years of Age n=3620 Participants Prasugrel and Low-dose Commercially-available Aspirin in participants less than (\<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel : 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.	Prasugrel: 75 Years of Age or Older n=1043 Participants Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.	Clopidogrel: <75 Years of Age n=3623 Participants Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (\<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.	Clopidogrel: 75 Years of Age or Older n=1040 Participants Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.	Total n=9326 Participants Total of all reporting groups
Region of Enrollment United Kingdom	33 participants n=5 Participants	21 participants n=7 Participants	40 participants n=5 Participants	12 participants n=4 Participants	106 participants n=21 Participants
Region of Enrollment Egypt	65 participants n=5 Participants	1 participants n=7 Participants	62 participants n=5 Participants	4 participants n=4 Participants	132 participants n=21 Participants
Region of Enrollment Hungary	86 participants n=5 Participants	43 participants n=7 Participants	87 participants n=5 Participants	44 participants n=4 Participants	260 participants n=21 Participants
Region of Enrollment Argentina	120 participants n=5 Participants	58 participants n=7 Participants	138 participants n=5 Participants	41 participants n=4 Participants	357 participants n=21 Participants
Region of Enrollment Poland	137 participants n=5 Participants	59 participants n=7 Participants	129 participants n=5 Participants	68 participants n=4 Participants	393 participants n=21 Participants
Region of Enrollment Belgium	7 participants n=5 Participants	7 participants n=7 Participants	7 participants n=5 Participants	8 participants n=4 Participants	29 participants n=21 Participants
Region of Enrollment Singapore	2 participants n=5 Participants	5 participants n=7 Participants	5 participants n=5 Participants	1 participants n=4 Participants	13 participants n=21 Participants
Region of Enrollment Bulgaria	216 participants n=5 Participants	48 participants n=7 Participants	209 participants n=5 Participants	55 participants n=4 Participants	528 participants n=21 Participants
Age Continuous	61.4 years STANDARD_DEVIATION 8.55 • n=5 Participants	80.3 years STANDARD_DEVIATION 4.29 • n=7 Participants	61.5 years STANDARD_DEVIATION 8.38 • n=5 Participants	80.3 years STANDARD_DEVIATION 4.39 • n=4 Participants	65.7 years STANDARD_DEVIATION 11.02 • n=21 Participants
Sex: Female, Male Female	1309 Participants n=5 Participants	520 Participants n=7 Participants	1290 Participants n=5 Participants	531 Participants n=4 Participants	3650 Participants n=21 Participants
Sex: Female, Male Male	2311 Participants n=5 Participants	523 Participants n=7 Participants	2333 Participants n=5 Participants	509 Participants n=4 Participants	5676 Participants n=21 Participants
Race/Ethnicity, Customized Caucasian	2362 participants n=5 Participants	767 participants n=7 Participants	2374 participants n=5 Participants	773 participants n=4 Participants	6276 participants n=21 Participants
Race/Ethnicity, Customized African	87 participants n=5 Participants	14 participants n=7 Participants	72 participants n=5 Participants	12 participants n=4 Participants	185 participants n=21 Participants
Race/Ethnicity, Customized Hispanic	321 participants n=5 Participants	109 participants n=7 Participants	346 participants n=5 Participants	86 participants n=4 Participants	862 participants n=21 Participants
Race/Ethnicity, Customized Asian	821 participants n=5 Participants	147 participants n=7 Participants	800 participants n=5 Participants	164 participants n=4 Participants	1932 participants n=21 Participants
Race/Ethnicity, Customized Other	29 participants n=5 Participants	6 participants n=7 Participants	30 participants n=5 Participants	5 participants n=4 Participants	70 participants n=21 Participants
Race/Ethnicity, Customized Unknown	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Region of Enrollment Portugal	18 participants n=5 Participants	11 participants n=7 Participants	14 participants n=5 Participants	11 participants n=4 Participants	54 participants n=21 Participants
Region of Enrollment Philippines	58 participants n=5 Participants	7 participants n=7 Participants	48 participants n=5 Participants	14 participants n=4 Participants	127 participants n=21 Participants
Region of Enrollment Taiwan	6 participants n=5 Participants	6 participants n=7 Participants	4 participants n=5 Participants	9 participants n=4 Participants	25 participants n=21 Participants
Region of Enrollment Slovakia	62 participants n=5 Participants	20 participants n=7 Participants	60 participants n=5 Participants	20 participants n=4 Participants	162 participants n=21 Participants
Region of Enrollment Greece	14 participants n=5 Participants	8 participants n=7 Participants	10 participants n=5 Participants	11 participants n=4 Participants	43 participants n=21 Participants
Region of Enrollment Costa Rica	5 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants	2 participants n=4 Participants	10 participants n=21 Participants
Region of Enrollment Thailand	30 participants n=5 Participants	17 participants n=7 Participants	36 participants n=5 Participants	10 participants n=4 Participants	93 participants n=21 Participants
Region of Enrollment Ukraine	326 participants n=5 Participants	28 participants n=7 Participants	311 participants n=5 Participants	42 participants n=4 Participants	707 participants n=21 Participants
Region of Enrollment Chile	28 participants n=5 Participants	15 participants n=7 Participants	33 participants n=5 Participants	13 participants n=4 Participants	89 participants n=21 Participants
Region of Enrollment Italy	71 participants n=5 Participants	44 participants n=7 Participants	70 participants n=5 Participants	47 participants n=4 Participants	232 participants n=21 Participants
Region of Enrollment India	513 participants n=5 Participants	56 participants n=7 Participants	508 participants n=5 Participants	64 participants n=4 Participants	1141 participants n=21 Participants
Region of Enrollment France	29 participants n=5 Participants	22 participants n=7 Participants	29 participants n=5 Participants	19 participants n=4 Participants	99 participants n=21 Participants
Region of Enrollment Denmark	21 participants n=5 Participants	7 participants n=7 Participants	17 participants n=5 Participants	10 participants n=4 Participants	55 participants n=21 Participants
Region of Enrollment Korea, Republic of	35 participants n=5 Participants	7 participants n=7 Participants	33 participants n=5 Participants	7 participants n=4 Participants	82 participants n=21 Participants
Region of Enrollment Panama	29 participants n=5 Participants	7 participants n=7 Participants	24 participants n=5 Participants	10 participants n=4 Participants	70 participants n=21 Participants
Region of Enrollment Turkey	76 participants n=5 Participants	24 participants n=7 Participants	81 participants n=5 Participants	19 participants n=4 Participants	200 participants n=21 Participants
Region of Enrollment Czech Republic	37 participants n=5 Participants	31 participants n=7 Participants	32 participants n=5 Participants	38 participants n=4 Participants	138 participants n=21 Participants
Region of Enrollment Mexico	38 participants n=5 Participants	15 participants n=7 Participants	40 participants n=5 Participants	16 participants n=4 Participants	109 participants n=21 Participants
Region of Enrollment Canada	58 participants n=5 Participants	14 participants n=7 Participants	61 participants n=5 Participants	13 participants n=4 Participants	146 participants n=21 Participants
Region of Enrollment Brazil	154 participants n=5 Participants	27 participants n=7 Participants	147 participants n=5 Participants	34 participants n=4 Participants	362 participants n=21 Participants
Region of Enrollment Romania	103 participants n=5 Participants	26 participants n=7 Participants	105 participants n=5 Participants	23 participants n=4 Participants	257 participants n=21 Participants
Region of Enrollment Croatia	63 participants n=5 Participants	28 participants n=7 Participants	60 participants n=5 Participants	31 participants n=4 Participants	182 participants n=21 Participants
Region of Enrollment Sweden	4 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants	1 participants n=4 Participants	14 participants n=21 Participants
Region of Enrollment United States	430 participants n=5 Participants	133 participants n=7 Participants	446 participants n=5 Participants	116 participants n=4 Participants	1125 participants n=21 Participants
Region of Enrollment Serbia	42 participants n=5 Participants	4 participants n=7 Participants	40 participants n=5 Participants	5 participants n=4 Participants	91 participants n=21 Participants
Region of Enrollment Spain	13 participants n=5 Participants	8 participants n=7 Participants	10 participants n=5 Participants	12 participants n=4 Participants	43 participants n=21 Participants
Region of Enrollment Ireland	5 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants	3 participants n=4 Participants	18 participants n=21 Participants
Region of Enrollment Israel	75 participants n=5 Participants	33 participants n=7 Participants	85 participants n=5 Participants	21 participants n=4 Participants	214 participants n=21 Participants
Region of Enrollment Russian Federation	128 participants n=5 Participants	22 participants n=7 Participants	135 participants n=5 Participants	14 participants n=4 Participants	299 participants n=21 Participants
Region of Enrollment Colombia	40 participants n=5 Participants	21 participants n=7 Participants	45 participants n=5 Participants	17 participants n=4 Participants	123 participants n=21 Participants
Region of Enrollment Switzerland	6 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants	6 participants n=4 Participants	20 participants n=21 Participants
Region of Enrollment Malaysia	35 participants n=5 Participants	7 participants n=7 Participants	33 participants n=5 Participants	9 participants n=4 Participants	84 participants n=21 Participants
Region of Enrollment Peru	58 participants n=5 Participants	19 participants n=7 Participants	67 participants n=5 Participants	12 participants n=4 Participants	156 participants n=21 Participants
Region of Enrollment Australia	13 participants n=5 Participants	6 participants n=7 Participants	15 participants n=5 Participants	7 participants n=4 Participants	41 participants n=21 Participants
Region of Enrollment South Africa	27 participants n=5 Participants	11 participants n=7 Participants	27 participants n=5 Participants	12 participants n=4 Participants	77 participants n=21 Participants
Region of Enrollment Netherlands	55 participants n=5 Participants	23 participants n=7 Participants	53 participants n=5 Participants	24 participants n=4 Participants	155 participants n=21 Participants
Region of Enrollment Tunisia	20 participants n=5 Participants	3 participants n=7 Participants	20 participants n=5 Participants	4 participants n=4 Participants	47 participants n=21 Participants
Region of Enrollment China	126 participants n=5 Participants	38 participants n=7 Participants	120 participants n=5 Participants	44 participants n=4 Participants	328 participants n=21 Participants
Region of Enrollment Finland	3 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants	2 participants n=4 Participants	13 participants n=21 Participants
Region of Enrollment Lithuania	29 participants n=5 Participants	8 participants n=7 Participants	32 participants n=5 Participants	4 participants n=4 Participants	73 participants n=21 Participants
Region of Enrollment Austria	6 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	5 participants n=4 Participants	23 participants n=21 Participants
Region of Enrollment Malta	9 participants n=5 Participants	1 participants n=7 Participants	10 participants n=5 Participants	2 participants n=4 Participants	22 participants n=21 Participants
Region of Enrollment Germany	46 participants n=5 Participants	20 participants n=7 Participants	46 participants n=5 Participants	21 participants n=4 Participants	133 participants n=21 Participants
Region of Enrollment New Zealand	10 participants n=5 Participants	3 participants n=7 Participants	10 participants n=5 Participants	3 participants n=4 Participants	26 participants n=21 Participants
History of Diabetes Yes	1393 participants n=5 Participants	363 participants n=7 Participants	1418 participants n=5 Participants	365 participants n=4 Participants	3539 participants n=21 Participants
History of Diabetes No	2221 participants n=5 Participants	678 participants n=7 Participants	2193 participants n=5 Participants	675 participants n=4 Participants	5767 participants n=21 Participants
History of Diabetes Unknown	6 participants n=5 Participants	2 participants n=7 Participants	12 participants n=5 Participants	0 participants n=4 Participants	20 participants n=21 Participants
History of Myocardial Infarction (MI) Yes	1556 participants n=5 Participants	426 participants n=7 Participants	1612 participants n=5 Participants	393 participants n=4 Participants	3987 participants n=21 Participants
History of Myocardial Infarction (MI) No	2035 participants n=5 Participants	603 participants n=7 Participants	1988 participants n=5 Participants	633 participants n=4 Participants	5259 participants n=21 Participants
History of Myocardial Infarction (MI) Unknown	29 participants n=5 Participants	14 participants n=7 Participants	23 participants n=5 Participants	14 participants n=4 Participants	80 participants n=21 Participants
History of Coronary Revascularization (PCI or CABG) Yes	1279 participants n=5 Participants	330 participants n=7 Participants	1365 participants n=5 Participants	299 participants n=4 Participants	3273 participants n=21 Participants
History of Coronary Revascularization (PCI or CABG) No	2332 participants n=5 Participants	703 participants n=7 Participants	2239 participants n=5 Participants	734 participants n=4 Participants	6008 participants n=21 Participants
History of Coronary Revascularization (PCI or CABG) Unknown	9 participants n=5 Participants	10 participants n=7 Participants	19 participants n=5 Participants	7 participants n=4 Participants	45 participants n=21 Participants
Clinical Presentation of UA or NSTEMI Unstable Angina	963 participants n=5 Participants	166 participants n=7 Participants	981 participants n=5 Participants	192 participants n=4 Participants	2302 participants n=21 Participants
Clinical Presentation of UA or NSTEMI Non-ST-segment Elevation Myocardial Infarction	2453 participants n=5 Participants	829 participants n=7 Participants	2434 participants n=5 Participants	804 participants n=4 Participants	6520 participants n=21 Participants
Clinical Presentation of UA or NSTEMI Unknown/Did not meet criteria	204 participants n=5 Participants	48 participants n=7 Participants	208 participants n=5 Participants	44 participants n=4 Participants	504 participants n=21 Participants

PRIMARY outcome

Timeframe: Randomization through end of study (30-month visit)

Population: All randomized participants

Outcome measures

Outcome measures
Measure	Prasugrel: <75 Years of Age n=3620 Participants Prasugrel and Low-dose Commercially-available Aspirin in participants less than (\<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.	Prasugrel: 75 Years of Age or Older n=1043 Participants Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.	Clopidogrel: <75 Years of Age n=3623 Participants Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (\<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.	Clopidogrel: 75 Years of Age or Older n=1040 Participants Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke	10.06 percentage of participants with an event	24.64 percentage of participants with an event	10.96 percentage of participants with an event	24.13 percentage of participants with an event

SECONDARY outcome

Timeframe: Randomization through end of study (30-month visit)

Population: All randomized participants

The percentage of participants is the total number of participants experiencing a CV death or nonfatal MI divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee.

Outcome measures

Outcome measures
Measure	Prasugrel: <75 Years of Age n=3620 Participants Prasugrel and Low-dose Commercially-available Aspirin in participants less than (\<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.	Prasugrel: 75 Years of Age or Older n=1043 Participants Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.	Clopidogrel: <75 Years of Age n=3623 Participants Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (\<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.	Clopidogrel: 75 Years of Age or Older n=1040 Participants Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
Percentage of Participants With a Composite Endpoint of CV Death and MI	9.61 percentage of participants with an event	22.53 percentage of participants with an event	10.21 percentage of participants with an event	22.69 percentage of participants with an event

SECONDARY outcome

Timeframe: Randomization through end of study (30-month visit)

Population: All randomized participants

The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, nonfatal stroke or re-hospitalization for a recurrent UA divided by number of participants in the treatment arm. Endpoints events were adjudicated by the Clinical Endpoint Committee.

Outcome measures

Outcome measures
Measure	Prasugrel: <75 Years of Age n=3620 Participants Prasugrel and Low-dose Commercially-available Aspirin in participants less than (\<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.	Prasugrel: 75 Years of Age or Older n=1043 Participants Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.	Clopidogrel: <75 Years of Age n=3623 Participants Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (\<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.	Clopidogrel: 75 Years of Age or Older n=1040 Participants Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
Percentage of Participants With a Composite Endpoint of CV Death, MI, Stroke, or Re-hospitalization for Recurrent Unstable Angina (UA)	12.13 percentage of participants with an event	26.27 percentage of participants with an event	12.83 percentage of participants with an event	25.67 percentage of participants with an event

SECONDARY outcome

Timeframe: Randomization through end of study (30-month visit)

Population: All randomized participants

The percentage of participants is the total number of participants experiencing an all-cause death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee.

Outcome measures

Outcome measures
Measure	Prasugrel: <75 Years of Age n=3620 Participants Prasugrel and Low-dose Commercially-available Aspirin in participants less than (\<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.	Prasugrel: 75 Years of Age or Older n=1043 Participants Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.	Clopidogrel: <75 Years of Age n=3623 Participants Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (\<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.	Clopidogrel: 75 Years of Age or Older n=1040 Participants Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
Percentage of Participants With a Composite Endpoint of All-cause Death, MI, or Stroke	10.61 percentage of participants with an event	27.04 percentage of participants with an event	11.12 percentage of participants with an event	26.83 percentage of participants with an event

SECONDARY outcome

Timeframe: Day 30 and 12 Months

Population: All participants who received at least 1 dose of study drug, and had a baseline and post-baseline PRU measurement at Day 30 or Month 12.

Platelet aggregation was measured by as measured by Accumetrics Verify Now™ P2Y12. Results were reported in P2Y12 Reaction Units (PRU). PRU represents the rate and extent of adenosine (ADP)-stimulated platelet aggregation. Lower values indicate greater P2Y12 platelet inhibition and lower platelet activity and aggregation. ANCOVA Model was used and values were corrected for treatment + baseline value + clopidogrel status at randomization.

Outcome measures

Outcome measures
Measure	Prasugrel: <75 Years of Age n=720 Participants Prasugrel and Low-dose Commercially-available Aspirin in participants less than (\<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.	Prasugrel: 75 Years of Age or Older n=158 Participants Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.	Clopidogrel: <75 Years of Age n=683 Participants Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (\<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.	Clopidogrel: 75 Years of Age or Older n=179 Participants Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
Platelet Aggregation Measures Day 30	93.280 P2Y12 Reaction Units (PRU) Standard Error 3.804	151.872 P2Y12 Reaction Units (PRU) Standard Error 8.148	193.489 P2Y12 Reaction Units (PRU) Standard Error 3.780	200.285 P2Y12 Reaction Units (PRU) Standard Error 8.238
Platelet Aggregation Measures Month 12 (n=386, 76, 400, 103)	94.529 P2Y12 Reaction Units (PRU) Standard Error 5.706	135.096 P2Y12 Reaction Units (PRU) Standard Error 14.631	199.003 P2Y12 Reaction Units (PRU) Standard Error 5.663	181.360 P2Y12 Reaction Units (PRU) Standard Error 14.380

SECONDARY outcome

Timeframe: Day 30 and 6 Months

Population: All randomized participants who received at least 1 dose of study therapy and had baseline and post-baseline BNP measurement at Day 30 or 6 Months.

Brain natriuretic peptide (BNP) is secreted by the ventricles of the heart in response to hemodynamic stress and is a biomarker associated with increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization.

Outcome measures

Outcome measures
Measure	Prasugrel: <75 Years of Age n=859 Participants Prasugrel and Low-dose Commercially-available Aspirin in participants less than (\<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.	Prasugrel: 75 Years of Age or Older n=196 Participants Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.	Clopidogrel: <75 Years of Age n=840 Participants Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (\<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.	Clopidogrel: 75 Years of Age or Older n=224 Participants Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
Biomarker Measurements of Inflammation/Hemodynamic Stress: Brain Natriuretic Peptide (BNP) Day 30	313.494 picograms per milliliter (pg/mL) Standard Error 1.039	1082.396 picograms per milliliter (pg/mL) Standard Error 1.093	319.345 picograms per milliliter (pg/mL) Standard Error 1.039	951.359 picograms per milliliter (pg/mL) Standard Error 1.092
Biomarker Measurements of Inflammation/Hemodynamic Stress: Brain Natriuretic Peptide (BNP) 6 Months (n=725, 125, 701, 174)	253.434 picograms per milliliter (pg/mL) Standard Error 1.049	770.132 picograms per milliliter (pg/mL) Standard Error 1.135	250.982 picograms per milliliter (pg/mL) Standard Error 1.049	722.750 picograms per milliliter (pg/mL) Standard Error 1.130

SECONDARY outcome

Timeframe: Day 30 and Month 6

Population: All randomized participants who received at least 1 dose of study therapy and had baseline and post-baseline CRP measurement at Day 30 or 6 Months.

C-Reactive Protein (CRP) is a biomarker associated with inflammation and increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization.

Outcome measures

Outcome measures
Measure	Prasugrel: <75 Years of Age n=888 Participants Prasugrel and Low-dose Commercially-available Aspirin in participants less than (\<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.	Prasugrel: 75 Years of Age or Older n=209 Participants Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.	Clopidogrel: <75 Years of Age n=863 Participants Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (\<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.	Clopidogrel: 75 Years of Age or Older n=226 Participants Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
Biomarker Measurements of Inflammation/Hemodynamic Stress: C-Reactive Protein (CRP) Day 30	2.330 milligrams per liter (mg/L) Standard Error 1.053	2.441 milligrams per liter (mg/L) Standard Error 1.150	2.287 milligrams per liter (mg/L) Standard Error 1.053	2.226 milligrams per liter (mg/L) Standard Error 1.150
Biomarker Measurements of Inflammation/Hemodynamic Stress: C-Reactive Protein (CRP) 6 Months (n=755, 143, 745, 178)	2.272 milligrams per liter (mg/L) Standard Error 1.060	1.593 milligrams per liter (mg/L) Standard Error 1.173	2.149 milligrams per liter (mg/L) Standard Error 1.059	1.543 milligrams per liter (mg/L) Standard Error 1.170

SECONDARY outcome

Timeframe: Baseline

Population: All randomized participants who provided a DNA sample.

Variation in the genes encoding the cytochrome P450 (CYP) enzymes (CYP2C19) can reduce the ability to metabolize clopidogrel and a reduced platelet response and have been associated with increased rates of CV events including CV death. Participants were classified as extensive metabolizers (EM); reduced metabolizers (RM); or unknown (UNK) metabolizers based on their CYP2C19 genotype. Possible extensive metabolizer (EM) phenotypes include EM=extensive metabolizer, UM=ultra-rapid metabolizer, and EM (non-UM) that are not UM. Possible reduced metabolizer (RM) phenotypes include IM=intermediate metabolizer and PM=poor metabolizer. Genotypes associated with each predicted phenotype are presented; predicted phenotype is presented first followed by the genotype. Percentage=(number of participants with the predicted phenotype and genotype divided by the total number of participants per arm) multiplied by 100.

Outcome measures

SECONDARY outcome

Timeframe: Baseline and follow-up (24 months)

Population: All randomized participants (combined \<75 years and 75 years and older) with SAQ data.

Seattle Angina Questionnaire (SAQ) is a validated, disease-specific questionnaire containing 11 questions (Q) yielding 5 summary scales related to angina: physical limitations, angina stability, angina frequency, treatment satisfaction and disease perception. In this study only angina frequency and the physical limitations scales were assessed. Anginal Frequency was assessed using Q3 and Q4 which consists of a Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how often a patient is having symptoms now. Physical limitations was assessed using Q1 which contains 9 items each assessed via Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how much a participant's condition is hampering their ability to do what they want to do. Scale scores are transformed to a 0-100 by subtracting the lowest possible score, dividing by the range of the scale, and multiplying by 100. Higher values equal better quality of life.

Outcome measures

Outcome measures
Measure	Prasugrel: <75 Years of Age n=1506 Participants Prasugrel and Low-dose Commercially-available Aspirin in participants less than (\<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.	Prasugrel: 75 Years of Age or Older n=1506 Participants Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.	Clopidogrel: <75 Years of Age Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (\<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.	Clopidogrel: 75 Years of Age or Older Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
Economic and Quality of Life Outcomes Baseline, physical limitations	67.8 units on a scale Standard Deviation 26.1	67.0 units on a scale Standard Deviation 26.5	—	—
Economic and Quality of Life Outcomes Baseline, angina frequency	73.6 units on a scale Standard Deviation 22.9	73.1 units on a scale Standard Deviation 23.5	—	—
Economic and Quality of Life Outcomes 24 Months, physical limitations (n=420, 412)	75.1 units on a scale Standard Deviation 24.4	74.5 units on a scale Standard Deviation 25.7	—	—
Economic and Quality of Life Outcomes 24 Months, angina frequency (n=420, 412)	89.7 units on a scale Standard Deviation 20.0	89.5 units on a scale Standard Deviation 19.1	—	—

SECONDARY outcome

Timeframe: Randomization through end of study (30-month visit)

Population: All randomized participants

All deaths, regardless of possible relatedness, with the exception of 1 event, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table. The 1 event which was not adjudicated was a result of the revocation of consent by the participant prior to their death. Deaths possibly related to study drug in the opinion of the investigator are also contained in the Serious Adverse Event (SAE) module.

Outcome measures

Outcome measures
Measure	Prasugrel: <75 Years of Age n=3620 Participants Prasugrel and Low-dose Commercially-available Aspirin in participants less than (\<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.	Prasugrel: 75 Years of Age or Older n=1043 Participants Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.	Clopidogrel: <75 Years of Age n=3623 Participants Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (\<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.	Clopidogrel: 75 Years of Age or Older n=1040 Participants Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
Summary of All Deaths Congestive Heart Failure	10 participants	21 participants	13 participants	23 participants
Summary of All Deaths Cardiogenic Shock	8 participants	4 participants	10 participants	9 participants
Summary of All Deaths Cardiac Rupture	0 participants	1 participants	0 participants	0 participants
Summary of All Deaths Myocardial Infarction	16 participants	24 participants	24 participants	21 participants
Summary of All Deaths Dysrhythmia	5 participants	2 participants	6 participants	3 participants
Summary of All Deaths Stent Thrombosis	0 participants	0 participants	0 participants	0 participants
Summary of All Deaths Directly Related to Revascularization-CABG or PCI	1 participants	1 participants	1 participants	1 participants
Summary of All Deaths Intracranial Hemorrhage	2 participants	1 participants	4 participants	1 participants
Summary of All Deaths Non-Hemorrhagic Stroke	4 participants	4 participants	4 participants	3 participants
Summary of All Deaths Sudden death due to cardiovascular event	75 participants	39 participants	70 participants	43 participants
Summary of All Deaths Pulmonary Embolism	0 participants	1 participants	2 participants	1 participants
Summary of All Deaths Stroke, unknown type	0 participants	1 participants	0 participants	0 participants
Summary of All Deaths Other Cardiovascular Event	6 participants	1 participants	0 participants	1 participants
Summary of All Deaths Cardiovascular event, unknown type	40 participants	41 participants	45 participants	45 participants
Summary of All Deaths Accidental	1 participants	0 participants	1 participants	1 participants
Summary of All Deaths Trauma	2 participants	3 participants	0 participants	1 participants
Summary of All Deaths Hemorrhage, not intracranial	1 participants	1 participants	0 participants	4 participants
Summary of All Deaths Infection	14 participants	21 participants	16 participants	17 participants
Summary of All Deaths Malignancy	14 participants	7 participants	14 participants	11 participants
Summary of All Deaths Suicide	1 participants	0 participants	0 participants	0 participants
Summary of All Deaths Other Non-Cardiovascular event	8 participants	4 participants	8 participants	6 participants
Summary of All Deaths Cause unknown (nonadjudicated event)	0 participants	1 participants	0 participants	0 participants

Adverse Events

Prasugrel

Serious events: 1573 serious events

Other events: 2581 other events

Deaths: 0 deaths

Clopidogrel

Serious events: 1594 serious events

Other events: 2494 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Prasugrel: <75 Years of Age n=2210 Participants Prasugrel and Low-dose Commercially-available Aspirin in participants less than (\<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.	Prasugrel: 75 Years of Age or Older n=639 Participants Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.	Clopidogrel: <75 Years of Age n=2237 Participants Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (\<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.	Clopidogrel: 75 Years of Age or Older n=650 Participants Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
Genotyping Related to Drug Metabolism UM, 1/17	24.0 percentage participants with geneotype	25.0 percentage participants with geneotype	25.1 percentage participants with geneotype	21.8 percentage participants with geneotype
Genotyping Related to Drug Metabolism UM, 17/17	5.1 percentage participants with geneotype	3.6 percentage participants with geneotype	5.4 percentage participants with geneotype	4.3 percentage participants with geneotype
Genotyping Related to Drug Metabolism EM (non-UM), 1/1	38.8 percentage participants with geneotype	42.1 percentage participants with geneotype	35.7 percentage participants with geneotype	41.2 percentage participants with geneotype
Genotyping Related to Drug Metabolism IM, 1/2	18.6 percentage participants with geneotype	18.3 percentage participants with geneotype	19.8 percentage participants with geneotype	19.7 percentage participants with geneotype
Genotyping Related to Drug Metabolism IM, 1/3	0.8 percentage participants with geneotype	0.6 percentage participants with geneotype	0.5 percentage participants with geneotype	0.6 percentage participants with geneotype
Genotyping Related to Drug Metabolism IM, 1/4	0.4 percentage participants with geneotype	0.0 percentage participants with geneotype	0.1 percentage participants with geneotype	0.3 percentage participants with geneotype
Genotyping Related to Drug Metabolism IM, 1/6	0.0 percentage participants with geneotype	0.2 percentage participants with geneotype	0.0 percentage participants with geneotype	0.2 percentage participants with geneotype
Genotyping Related to Drug Metabolism IM, 1/8	0.1 percentage participants with geneotype	0.5 percentage participants with geneotype	0.4 percentage participants with geneotype	0.3 percentage participants with geneotype
Genotyping Related to Drug Metabolism PM, 2/2	3.9 percentage participants with geneotype	2.2 percentage participants with geneotype	4.3 percentage participants with geneotype	3.8 percentage participants with geneotype
Genotyping Related to Drug Metabolism PM, 2/3	0.3 percentage participants with geneotype	0.2 percentage participants with geneotype	0.3 percentage participants with geneotype	0.3 percentage participants with geneotype
Genotyping Related to Drug Metabolism PM, 2/4	0.0 percentage participants with geneotype	0.2 percentage participants with geneotype	0.2 percentage participants with geneotype	0.2 percentage participants with geneotype
Genotyping Related to Drug Metabolism PM, 2/6	0.0 percentage participants with geneotype	0.0 percentage participants with geneotype	0.0 percentage participants with geneotype	0.0 percentage participants with geneotype
Genotyping Related to Drug Metabolism PM, 2/8	0.0 percentage participants with geneotype	0.0 percentage participants with geneotype	0.0 percentage participants with geneotype	0.0 percentage participants with geneotype
Genotyping Related to Drug Metabolism PM, 3/3	0.0 percentage participants with geneotype	0.0 percentage participants with geneotype	0.2 percentage participants with geneotype	0.0 percentage participants with geneotype
Genotyping Related to Drug Metabolism UNK, 1/10	0.0 percentage participants with geneotype	0.0 percentage participants with geneotype	0.1 percentage participants with geneotype	0.0 percentage participants with geneotype
Genotyping Related to Drug Metabolism UNK, 1/13	0.0 percentage participants with geneotype	0.2 percentage participants with geneotype	0.0 percentage participants with geneotype	0.0 percentage participants with geneotype
Genotyping Related to Drug Metabolism UNK, 1/9	0.1 percentage participants with geneotype	0.2 percentage participants with geneotype	0.0 percentage participants with geneotype	0.0 percentage participants with geneotype
Genotyping Related to Drug Metabolism UNK, 1/9, 9/17	0.0 percentage participants with geneotype	0.0 percentage participants with geneotype	0.0 percentage participants with geneotype	0.0 percentage participants with geneotype
Genotyping Related to Drug Metabolism UNK, 13/17	0.0 percentage participants with geneotype	0.0 percentage participants with geneotype	0.0 percentage participants with geneotype	0.0 percentage participants with geneotype
Genotyping Related to Drug Metabolism UNK, 2/13	0.0 percentage participants with geneotype	0.0 percentage participants with geneotype	0.0 percentage participants with geneotype	0.0 percentage participants with geneotype
Genotyping Related to Drug Metabolism UNK, 2/17	6.3 percentage participants with geneotype	6.1 percentage participants with geneotype	6.8 percentage participants with geneotype	6.2 percentage participants with geneotype
Genotyping Related to Drug Metabolism UNK, 2/9	0.0 percentage participants with geneotype	0.0 percentage participants with geneotype	0.1 percentage participants with geneotype	0.0 percentage participants with geneotype
Genotyping Related to Drug Metabolism UNK, 3/17	0.1 percentage participants with geneotype	0.0 percentage participants with geneotype	0.0 percentage participants with geneotype	0.3 percentage participants with geneotype
Genotyping Related to Drug Metabolism UNK, 4/17	0.2 percentage participants with geneotype	0.2 percentage participants with geneotype	0.2 percentage participants with geneotype	0.0 percentage participants with geneotype
Genotyping Related to Drug Metabolism UNK, 4/9	0.0 percentage participants with geneotype	0.0 percentage participants with geneotype	0.0 percentage participants with geneotype	0.0 percentage participants with geneotype
Genotyping Related to Drug Metabolism UNK, 6/17	0.0 percentage participants with geneotype	0.0 percentage participants with geneotype	0.0 percentage participants with geneotype	0.2 percentage participants with geneotype
Genotyping Related to Drug Metabolism UNK, 8/17	0.2 percentage participants with geneotype	0.0 percentage participants with geneotype	0.1 percentage participants with geneotype	0.0 percentage participants with geneotype
Genotyping Related to Drug Metabolism UNK, 9/17	0.0 percentage participants with geneotype	0.0 percentage participants with geneotype	0.0 percentage participants with geneotype	0.0 percentage participants with geneotype
Genotyping Related to Drug Metabolism UNK, Undefined genotype	0.7 percentage participants with geneotype	0.6 percentage participants with geneotype	0.5 percentage participants with geneotype	0.6 percentage participants with geneotype

Measure	Prasugrel n=4623 participants at risk Prasugrel and Low-dose Commercially-available Aspirin in participants. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight and age), oral, once daily as maintenance dose through end of study.	Clopidogrel n=4617 participants at risk Clopidogrel and Low-Dose Commercially-available Aspirin in participants. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
Blood and lymphatic system disorders Anaemia	2.2% 103/4623 • Number of events 106 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	1.6% 75/4617 • Number of events 76 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Cardiac disorders Angina pectoris	4.6% 213/4623 • Number of events 267 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	5.4% 250/4617 • Number of events 320 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Cardiac disorders Atrial fibrillation	2.0% 93/4623 • Number of events 102 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	2.4% 110/4617 • Number of events 116 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Gastrointestinal disorders Abdominal pain upper	0.89% 41/4623 • Number of events 44 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	1.1% 49/4617 • Number of events 51 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Gastrointestinal disorders Constipation	1.5% 71/4623 • Number of events 76 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	1.8% 81/4617 • Number of events 83 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Gastrointestinal disorders Diarrhoea	2.0% 94/4623 • Number of events 99 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	1.9% 87/4617 • Number of events 92 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Gastrointestinal disorders Dyspepsia	1.1% 51/4623 • Number of events 51 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	1.1% 51/4617 • Number of events 52 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Gastrointestinal disorders Gastritis	1.1% 50/4623 • Number of events 52 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	1.3% 60/4617 • Number of events 60 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.00% 46/4623 • Number of events 47 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	1.0% 48/4617 • Number of events 49 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Gastrointestinal disorders Nausea	1.6% 74/4623 • Number of events 78 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	1.7% 80/4617 • Number of events 83 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
General disorders Asthenia	1.2% 57/4623 • Number of events 59 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	0.97% 45/4617 • Number of events 47 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
General disorders Chest pain	0.80% 37/4623 • Number of events 45 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	1.0% 48/4617 • Number of events 68 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
General disorders Fatigue	1.8% 82/4623 • Number of events 84 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	1.5% 70/4617 • Number of events 75 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
General disorders Non-cardiac chest pain	2.3% 108/4623 • Number of events 125 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	2.6% 120/4617 • Number of events 149 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
General disorders Oedema peripheral	1.9% 90/4623 • Number of events 94 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	2.7% 123/4617 • Number of events 132 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Infections and infestations Bronchitis	1.9% 87/4623 • Number of events 94 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	1.8% 84/4617 • Number of events 90 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Infections and infestations Nasopharyngitis	1.5% 68/4623 • Number of events 74 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	1.6% 74/4617 • Number of events 91 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Infections and infestations Pneumonia	0.84% 39/4623 • Number of events 42 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	1.1% 49/4617 • Number of events 51 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Infections and infestations Upper respiratory tract infection	1.2% 57/4623 • Number of events 63 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	1.6% 75/4617 • Number of events 82 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Infections and infestations Urinary tract infection	2.2% 101/4623 • Number of events 116 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	2.2% 101/4617 • Number of events 112 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Injury, poisoning and procedural complications Contusion	3.8% 175/4623 • Number of events 229 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	2.3% 107/4617 • Number of events 165 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Metabolism and nutrition disorders Diabetes mellitus	1.4% 64/4623 • Number of events 65 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	1.7% 79/4617 • Number of events 79 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Musculoskeletal and connective tissue disorders Arthralgia	1.4% 64/4623 • Number of events 71 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	1.4% 63/4617 • Number of events 68 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Musculoskeletal and connective tissue disorders Back pain	1.8% 85/4623 • Number of events 85 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	1.9% 90/4617 • Number of events 96 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	1.6% 72/4623 • Number of events 76 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	1.5% 69/4617 • Number of events 70 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Nervous system disorders Dizziness	2.6% 121/4623 • Number of events 131 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	3.1% 142/4617 • Number of events 158 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Nervous system disorders Headache	2.4% 109/4623 • Number of events 115 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	2.5% 116/4617 • Number of events 127 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Psychiatric disorders Anxiety	1.4% 63/4623 • Number of events 63 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	1.3% 61/4617 • Number of events 63 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Psychiatric disorders Depression	1.3% 60/4623 • Number of events 61 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	1.4% 66/4617 • Number of events 67 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Psychiatric disorders Insomnia	1.1% 53/4623 • Number of events 53 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	1.5% 67/4617 • Number of events 67 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Respiratory, thoracic and mediastinal disorders Cough	3.0% 140/4623 • Number of events 142 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	2.9% 134/4617 • Number of events 146 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.1% 98/4623 • Number of events 110 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	2.5% 116/4617 • Number of events 120 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.74% 34/4623 • Number of events 35 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	1.1% 49/4617 • Number of events 50 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	4.0% 184/4623 • Number of events 265 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	2.4% 112/4617 • Number of events 149 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Skin and subcutaneous tissue disorders Ecchymosis	2.7% 123/4623 • Number of events 166 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	1.4% 65/4617 • Number of events 78 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Vascular disorders Haematoma	2.5% 116/4623 • Number of events 141 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	1.4% 63/4617 • Number of events 78 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Vascular disorders Hypertension	3.5% 161/4623 • Number of events 162 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	3.3% 153/4617 • Number of events 156 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Vascular disorders Hypotension	1.0% 48/4623 • Number of events 50 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.	1.2% 54/4617 • Number of events 55 Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.