A Comparison of Antiplatelet Therapies in Asian Subjects With Acute Coronary Syndrome

A Comparison of Platelet Inhibition Following Prasugrel or Clopidogrel Administration in Asian Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00830960

Enrollment

720

Registered

2009-01-28

Start date

2009-02-28

Completion date

2010-06-30

Last updated

2011-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Brief summary

The study will compare the safety and efficacy of prasugrel, administered at different doses with clopidogrel in the treatment of Asian participants with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention.

Interventions

DRUGPrasugrel

Oral, daily, 90 days

DRUGClopidogrel

Oral, daily, 90 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* A person who has been diagnosed with acute coronary syndrome (ACS) and is to undergo a percutaneous coronary intervention (PCI) * A person who is of East or Southeast Asian descent * A person who is of the legal age of 18 (or age 21 in Singapore) and is mentally competent to provide a signed written informed consent before entering the study * If a woman is of childbearing potential, she must test negative for pregnancy and agree to use a reliable method of birth control

Exclusion criteria

* A person who has a severe cardiovascular condition such as cardiogenic shock at the time of randomization, ventricular arrhythmias or congestive heart failure * A person who is at an increased risk of bleeding (e.g. active internal bleeding, history of bleeding disorder, recent fibrinolytic therapy before randomization into the study) * A person who has prior history of any one of the following: ischemic or hemorrhagic stroke; intracranial neoplasm, arteriovenous malformation, or aneurysm; prior history of transient ischemic attack (TIA) * A person who needs to take other antiplatelet therapy other than Aspirin for the duration of the study * A person who receives daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued * A person who has a severe liver disease, such as cirrhosis * A person who has a condition such as alcoholism, mental illness, or drug dependence

Design outcomes

Primary

Measure	Time frame	Description
Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation (P2Y12 Reaction Units; PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 4 Hours Post-Loading Dose (LD) in Primary Cohort (≥60 kg and <75 Years)	At 4 hours following LD administration	ADP-induced PRU represents the rate and extent of ADP-stimulated platelet aggregation and serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition. Observed PRU values are presented with statistical comparisons of difference in least squares mean (LS mean) PRU values between prasugrel and clopidogrel. Efficacy analyses are analyzed and presented separately for the LD and maintenance dose (MD) phase.
Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Days During Maintenance Dose (MD) Administration in Primary Cohort	At 30 days during MD therapy	Efficacy analyses are analyzed and presented separately for the loading dose (LD) and MD phase. This primary outcome analysis compares PRU for the 3 prasugrel MDs (10 mg, 7.5 mg, and 5 mg) with the clopidogrel 75-mg MD at 30 days post-MD in the primary cohort (participants who weighed ≥60 kg and were \<75 years). ADP-induced PRU serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition. Observed PRU values are presented with statistical comparisons of LS mean difference between prasugrel and clopidogrel.

Secondary

Measure	Time frame	Description
Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort	30 minutes, 2 hours, and 4 hours following LD administration	A higher percentage (percent inhibition least squares mean \[LS mean\]) represents greater platelet inhibition.
Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) During the Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort	30 days and at 90 days during MD therapy	A higher percentage (percent inhibition least squares mean \[LS mean\]) represents greater platelet inhibition.
Summary of Myocardial Infarction (MI), Stroke, Stent Thrombosis and Urgent Target Vessel Revascularization (UTVR) in Primary Cohort and Low Weight/Elderly Cohort	Randomization through end of study (90 days)	Nonfatal MI: American College of Cardiology (ACC) definition Nonfatal stroke: rapid onset of new, persistent neurologic deficit lasting \>24 hours; classified as either ischemic or hemorrhagic based on imaging data, if available, or uncertain cause if imaging data was not available. Stent thrombosis: defined as definite, probable, or possible, based on Academic Research Consortium definitions. UTVR: percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) for recurrent ischemia. Revascularization must have included the vessel(s) dilated at the initial procedure
Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Non-fatal Stroke	30 days and 90 days	Risk was defined as the number of participants with events of CV death, nonfatal MI, or nonfatal stroke. CV death: death caused by CV event or not clearly attributable to non-CV causes. Nonfatal MI: per adapted American College of Cardiology definition. Nonfatal stroke: rapid onset of new, persistent neurologic deficit lasting more than 24 hours; either ischemic or hemorrhagic based on imaging data, if available, or uncertain cause if imaging data was not available. As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed.
Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Urgent Target Vessel Revascularization (UTVR)	30 days and 90 days	Risk was defined as the number of participants with events of CV death, nonfatal MI, or UTVR. UTVR: percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) for recurrent ischemia. Revascularization must have included the vessel(s) dilated at the initial procedure. As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed.
Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Recurrent Myocardial Ischemia Requiring Hospitalization	30 days and 90 days	Risk was defined as the number of events of CV death, nonfatal MI, nonfatal stroke or recurrent myocardial ischemia requiring hospitalization. Recurrent myocardial ischemia requiring hospitalization: rehospitalization for symptoms of myocardial ischemia at rest with either new ST-segment deviation ≥1 mm, or performance of a coronary revascularization procedure percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) during the same hospital stay. As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed.
Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Urgent Target Vessel Revascularization (UTVR), or Recurrent Myocardial Ischemia Requiring Hospitalization (Analyzed Individually)	30 days and 90 days	Risk was defined as the number of participants with events of CV death, nonfatal MI, nonfatal stroke, UTVR, or recurrent myocardial ischemia requiring hospitalization.
Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts.	At 30 minutes, 2 hours, and 4 hours following LD administration	Efficacy analyses analyzed and presented separately for LD and maintenance dose (MD) phase. Analysis compares PRU for prasugrel LDs (30 mg and 60 mg) with clopidogrel 300-mg LD at 30 minutes post-LD. Data for Primary Cohort at 4 hours post-LD, already presented in first Primary Outcome Measure, are also presented here. ADP-induced PRU serves as biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition. Observed PRU values presented with statistical comparisons of least-squares mean (LS mean) difference between prasugrel and clopidogrel.
Risk of Definite, Probable, or Possible Stent Thrombosis Per Academic Research Consortium (ARC) Definition	90 days	Risk was defined as the number of participants with events of definite, probable, or possible stent thrombosis. As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed.
Risk of All-cause Death in Primary Cohort and Low Weight/Elderly Cohort	Randomization through end of study (90 days)	Risk was defined as the number of participants with events of all-cause death.
Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	Randomization through end of study (90 days)	Bleeding events were classified and analyzed in accordance with the TIMI criteria definitions. Major bleeding: any intracranial hemorrhage (ICR) OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 grams/deciliter (gm/dL) from baseline. Minor bleeding: any clinically overt bleeding associated with a fall in Hgb of ≥3 but \<5 gm/dL from baseline. Insignificant bleeding: any bleeding event that does not meet criteria for a Major or Minor bleed.
Incidence of CABG-related TIMI Major or Minor Bleeding.	Randomization through end of study (90 days)	—
Inpatient Healthcare Resource Utilization	Initial hospitalization, 30 days, 90 days	Healthcare resource utilization data were modeled from historical analyses to determine initial hospitalization costs, total 30-day medical care costs, and total 90-day medical care costs.
Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary	Baseline to 4 hours post-loading dose (LD), 30 days and 90 days during maintenance dose (MD) phase	The primary hypothesis for the genetics substudy was that CYP2C19 genetic variation has a significant effect on pharmacodynamic (PD) response to clopidogrel but not on PD response to prasugrel per change in PRU as measured by the Accumetrics VerifyNow P2Y12 device. Participants were classified by CYP2C19 genotype into predicted metabolic phenotypes according to literature-based functional predictions. These classifications were clustered into 2 groups: extensive metabolizer (EM) and reduced metabolizer (RM). A higher value for change in PRU indicates a greater level of platelet inhibition.
Risk of CV Death, Nonfatal MI, Nonfatal Stroke, UTVR, or Recurrent Myocardial Ischemia Requiring Hospitalization (Analyzed Individually)	30 days and 90 days	Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Urgent Target Vessel Revascularization (UTVR), or Recurrent Myocardial Ischemia Requiring Hospitalization (Analyzed Individually)
Risk of Definite or Probable Stent Thrombosis Per ARC (Academic Research Consortium) Definition	30 days and 90 days	Risk was defined as the number of participants with events of definite or probable stent thrombosis. As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed.
Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at During Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort	At 30 Days and 90 days during MD therapy	Efficacy analyses analyzed and presented separately for loading dose (LD) and MD phase. Analysis compares PRU for 3 prasugrel MDs (10 mg, 7.5 mg, and 5 mg) with clopidogrel 75-mg MD at 30 days post-MD. Data for Primary Cohort at 30 days post-LD, already presented in second Primary Outcome Measure, are also presented here. ADP-induced PRU serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition. Observed PRU values are presented with statistical comparisons of least squares (LS) mean difference between prasugrel and clopidogrel.

Countries

China, South Korea, Taiwan, Thailand

Participant flow

Recruitment details

This study had 4 treatment arms and had 2 cohorts; a Primary Cohort (≥60 kilograms \[kg\] and age \<75 years) and a Low Weight/Elderly cohort (\<60 kg or age ≥75 years). Randomization was stratified by country, cohort and anticipated glycoprotein (GP) IIb/IIIa inhibitor use.

Pre-assignment details

One participant who was enrolled based on weight \>60 kg was not assigned to primary cohort due to no weight entered in case report form. Low Weight/Elderly Cohort was only assigned to prasugrel 30-mg loading dose (LD)/5-mg maintenance dose (MD) or clopidogrel 300-mg LD/75-mg MD due to evidence of increased bleeding risk for these populations.

Participants by arm

Arm	Count
Prasugrel 60/10 Primary Study treatment of prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age \<75 years) Reporting groups for Baseline Characteristics do not include all randomized participants (n=720), but includes all randomized participants who received at least 1 dose of study drug.	117
Prasugrel 30/7.5 Primary Study treatment of prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \<75 years)	122
Prasugrel 30/5 Primary Study treatment of prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \<75 years)	133
Clopidogrel 300/75 Primary Study treatment of clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age \<75 years)	135
Prasugrel 30/5 Low Weight/Elderly Study treatment of prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight \<60 kg or age ≥75 years)	91
Clopidogrel 300/75 Low Weight/Elderly Study treatment of clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight \<60 kg or age ≥75 years)	93
Total	691

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005
Overall Study	Death	5	4	3	2	6	1
Overall Study	Lost to Follow-up	1	1	1	0	0	1
Overall Study	No study drug received	7	2	4	3	5	7
Overall Study	Sponsor Decision	1	2	3	4	5	7
Overall Study	Withdrawal by Subject	19	19	18	23	16	21

Baseline characteristics

Characteristic	Prasugrel 30/7.5 Primary	Total	Clopidogrel 300/75 Low Weight/Elderly	Prasugrel 30/5 Low Weight/Elderly	Prasugrel 60/10 Primary	Clopidogrel 300/75 Primary	Prasugrel 30/5 Primary
Age Continuous Mean Age Overall	57.7 years STANDARD_DEVIATION 9.47	60.8 years STANDARD_DEVIATION 11.13	69.1 years STANDARD_DEVIATION 12.08	68.5 years STANDARD_DEVIATION 9.74	58.3 years STANDARD_DEVIATION 9.83	58.3 years STANDARD_DEVIATION 8.95	57.2 years STANDARD_DEVIATION 10.49
Body Mass Index (BMI) BMI	25.75 kilograms per square meter (kg/m²) STANDARD_DEVIATION 2.99	24.74 kilograms per square meter (kg/m²) STANDARD_DEVIATION 3.51	22.10 kilograms per square meter (kg/m²) STANDARD_DEVIATION 3.166	22.02 kilograms per square meter (kg/m²) STANDARD_DEVIATION 4.106	25.86 kilograms per square meter (kg/m²) STANDARD_DEVIATION 2.907	26.19 kilograms per square meter (kg/m²) STANDARD_DEVIATION 2.999	26.06 kilograms per square meter (kg/m²) STANDARD_DEVIATION 2.637
Qualifying Diagnosis Non-ST segment elevation myocardial infarction	16 participants	87 participants	10 participants	10 participants	13 participants	17 participants	21 participants
Qualifying Diagnosis ST segment elevation myocardial infarction	64 participants	395 participants	53 participants	55 participants	72 participants	77 participants	74 participants
Qualifying Diagnosis Unstable angina (UA)	42 participants	209 participants	30 participants	26 participants	32 participants	41 participants	38 participants
Region of Enrollment China	85 participants	483 participants	61 participants	64 participants	85 participants	95 participants	93 participants
Region of Enrollment Korea, Republic of	19 participants	101 participants	15 participants	13 participants	15 participants	19 participants	20 participants
Region of Enrollment Taiwan	14 participants	78 participants	11 participants	10 participants	12 participants	16 participants	15 participants
Region of Enrollment Thailand	4 participants	29 participants	6 participants	4 participants	5 participants	5 participants	5 participants
Sex: Female, Male Female	14 Participants	174 Participants	48 Participants	45 Participants	16 Participants	24 Participants	27 Participants
Sex: Female, Male Male	108 Participants	517 Participants	45 Participants	46 Participants	101 Participants	111 Participants	106 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	54 / 117	38 / 122	45 / 133	49 / 135	28 / 91	34 / 93	1 / 1
serious Total, serious adverse events	8 / 117	7 / 122	4 / 133	6 / 135	9 / 91	10 / 93	0 / 1

Outcome results

Primary

Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Days During Maintenance Dose (MD) Administration in Primary Cohort

Efficacy analyses are analyzed and presented separately for the loading dose (LD) and MD phase. This primary outcome analysis compares PRU for the 3 prasugrel MDs (10 mg, 7.5 mg, and 5 mg) with the clopidogrel 75-mg MD at 30 days post-MD in the primary cohort (participants who weighed ≥60 kg and were \<75 years). ADP-induced PRU serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition. Observed PRU values are presented with statistical comparisons of LS mean difference between prasugrel and clopidogrel.

Time frame: At 30 days during MD therapy

Population: Per protocol set (PPS) MD population~PPS: all randomized participants who had at least 1 dose of study drug, ≥1 post-baseline platelet aggregation measurement, and no significant protocol violations~MD population: received percutaneous coronary intervention (PCI) for index event

Arm	Measure	Value (MEAN)	Dispersion
Prasugrel 60-mg LD Primary	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Days During Maintenance Dose (MD) Administration in Primary Cohort	71.6 PRU	Standard Deviation 65.56
Prasugrel 30-mg LD Primary	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Days During Maintenance Dose (MD) Administration in Primary Cohort	99.3 PRU	Standard Deviation 72.63
Clopidogrel 300-mg LD Primary	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Days During Maintenance Dose (MD) Administration in Primary Cohort	150.8 PRU	Standard Deviation 77.76
Prasugrel 30-mg LD Low Weight/Elderly	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Days During Maintenance Dose (MD) Administration in Primary Cohort	206.5 PRU	Standard Deviation 72.68

p-value: <0.000195% CI: [-143, -76]Mixed Models Analysis

p-value: <0.000195% CI: [-123, -60]Mixed Models Analysis

p-value: 0.00295% CI: [-83, -19]Mixed Models Analysis

Primary

Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation (P2Y12 Reaction Units; PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 4 Hours Post-Loading Dose (LD) in Primary Cohort (≥60 kg and <75 Years)

ADP-induced PRU represents the rate and extent of ADP-stimulated platelet aggregation and serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition. Observed PRU values are presented with statistical comparisons of difference in least squares mean (LS mean) PRU values between prasugrel and clopidogrel. Efficacy analyses are analyzed and presented separately for the LD and maintenance dose (MD) phase.

Time frame: At 4 hours following LD administration

Population: Per Protocol Set (PPS) LD population~PPS: all randomized participants with ≥1 dose study drug, ≥1 post-baseline platelet aggregation measurement, no significant protocol violations~LD population: never used glycoprotein (GP) IIb/IIIa inhibitor during index hospitalization and received percutaneous coronary intervention (PCI) for index event

Arm	Measure	Value (MEAN)	Dispersion
Prasugrel 60-mg LD Primary	Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation (P2Y12 Reaction Units; PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 4 Hours Post-Loading Dose (LD) in Primary Cohort (≥60 kg and <75 Years)	88.5 PRU	Standard Deviation 104.86
Prasugrel 30-mg LD Primary	Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation (P2Y12 Reaction Units; PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 4 Hours Post-Loading Dose (LD) in Primary Cohort (≥60 kg and <75 Years)	124.2 PRU	Standard Deviation 117.28
Clopidogrel 300-mg LD Primary	Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation (P2Y12 Reaction Units; PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 4 Hours Post-Loading Dose (LD) in Primary Cohort (≥60 kg and <75 Years)	261.8 PRU	Standard Deviation 83.87

p-value: <0.000195% CI: [-229, -137]Mixed Models Analysis

p-value: <0.000195% CI: [-177, -102]Mixed Models Analysis

Secondary

Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts.

Efficacy analyses analyzed and presented separately for LD and maintenance dose (MD) phase. Analysis compares PRU for prasugrel LDs (30 mg and 60 mg) with clopidogrel 300-mg LD at 30 minutes post-LD. Data for Primary Cohort at 4 hours post-LD, already presented in first Primary Outcome Measure, are also presented here. ADP-induced PRU serves as biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition. Observed PRU values presented with statistical comparisons of least-squares mean (LS mean) difference between prasugrel and clopidogrel.

Time frame: At 30 minutes, 2 hours, and 4 hours following LD administration

Population: Per Protocol Set (PPS) LD population PPS: all randomized participants with at least 1 dose study drug, ≥1 post-baseline platelet aggregation measurement, no significant protocol violations~LD population: never used glycoprotein (GP)IIb/IIIa inhibitor during index hospitalization, received percutaneous coronary intervention (PCI) for index event

Arm	Measure	Group	Value (MEAN)	Dispersion
Prasugrel 60-mg LD Primary	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts.	30 min (n=40, n=79, n=48, n=33, n=34)	250.5 PRU	Standard Deviation 109.02
Prasugrel 60-mg LD Primary	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts.	4 hours (n=35, n=79, n=44, n=33, n=33)	88.5 PRU	Standard Deviation 104.86
Prasugrel 60-mg LD Primary	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts.	2 hours (n=37, n=80, n=49, n=33, n=33)	116.9 PRU	Standard Deviation 116.48
Prasugrel 30-mg LD Primary	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts.	2 hours (n=37, n=80, n=49, n=33, n=33)	178.8 PRU	Standard Deviation 128.37
Prasugrel 30-mg LD Primary	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts.	30 min (n=40, n=79, n=48, n=33, n=34)	280.4 PRU	Standard Deviation 112.58
Prasugrel 30-mg LD Primary	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts.	4 hours (n=35, n=79, n=44, n=33, n=33)	124.2 PRU	Standard Deviation 117.28
Clopidogrel 300-mg LD Primary	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts.	2 hours (n=37, n=80, n=49, n=33, n=33)	289.5 PRU	Standard Deviation 71.77
Clopidogrel 300-mg LD Primary	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts.	30 min (n=40, n=79, n=48, n=33, n=34)	312.1 PRU	Standard Deviation 72.41
Clopidogrel 300-mg LD Primary	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts.	4 hours (n=35, n=79, n=44, n=33, n=33)	261.8 PRU	Standard Deviation 83.87
Prasugrel 30-mg LD Low Weight/Elderly	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts.	30 min (n=40, n=79, n=48, n=33, n=34)	311.2 PRU	Standard Deviation 96.46
Prasugrel 30-mg LD Low Weight/Elderly	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts.	4 hours (n=35, n=79, n=44, n=33, n=33)	127.3 PRU	Standard Deviation 106.38
Prasugrel 30-mg LD Low Weight/Elderly	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts.	2 hours (n=37, n=80, n=49, n=33, n=33)	171.8 PRU	Standard Deviation 123.37
Clopidogrel 300-mg LD Low Weight/Elderly	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts.	2 hours (n=37, n=80, n=49, n=33, n=33)	339.0 PRU	Standard Deviation 74.03
Clopidogrel 300-mg LD Low Weight/Elderly	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts.	30 min (n=40, n=79, n=48, n=33, n=34)	379.5 PRU	Standard Deviation 53.29
Clopidogrel 300-mg LD Low Weight/Elderly	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts.	4 hours (n=35, n=79, n=44, n=33, n=33)	337.8 PRU	Standard Deviation 85.15

p-value: 0.005895% CI: [-97, -17]Mixed Models Analysis

p-value: 0.036595% CI: [-68, -2]Mixed Models Analysis

p-value: 0.000495% CI: [-104, -32]Mixed Models Analysis

p-value: <0.000195% CI: [-211, -110]Mixed Models Analysis

p-value: <0.000195% CI: [-156, -73]Mixed Models Analysis

p-value: <0.000195% CI: [-216, -125]Mixed Models Analysis

p-value: <0.000195% CI: [-259, -167]Mixed Models Analysis

Secondary

Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at During Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort

Efficacy analyses analyzed and presented separately for loading dose (LD) and MD phase. Analysis compares PRU for 3 prasugrel MDs (10 mg, 7.5 mg, and 5 mg) with clopidogrel 75-mg MD at 30 days post-MD. Data for Primary Cohort at 30 days post-LD, already presented in second Primary Outcome Measure, are also presented here. ADP-induced PRU serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition. Observed PRU values are presented with statistical comparisons of least squares (LS) mean difference between prasugrel and clopidogrel.

Time frame: At 30 Days and 90 days during MD therapy

Population: Per Protocol Set (PPS) MD population PPS: all randomized participants who had at least 1 dose of study drug, ≥1 post-baseline platelet aggregation measurement, and no significant protocol violations in MD population: received percutaneous coronary intervention (PCI) for index event

Arm	Measure	Group	Value (MEAN)	Dispersion
Prasugrel 60-mg LD Primary	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at During Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort	30 days (n=69, n=63, n=69, n=78, n=47, n=48)	71.6 PRU	Standard Deviation 65.56
Prasugrel 60-mg LD Primary	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at During Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort	90 Days (n=60, n=57, n=64, n=72, n=43, n=42)	64.8 PRU	Standard Deviation 55.99
Prasugrel 30-mg LD Primary	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at During Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort	30 days (n=69, n=63, n=69, n=78, n=47, n=48)	99.3 PRU	Standard Deviation 72.63
Prasugrel 30-mg LD Primary	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at During Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort	90 Days (n=60, n=57, n=64, n=72, n=43, n=42)	89.4 PRU	Standard Deviation 91.75
Clopidogrel 300-mg LD Primary	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at During Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort	30 days (n=69, n=63, n=69, n=78, n=47, n=48)	150.8 PRU	Standard Deviation 77.76
Clopidogrel 300-mg LD Primary	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at During Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort	90 Days (n=60, n=57, n=64, n=72, n=43, n=42)	138.5 PRU	Standard Deviation 80.42
Prasugrel 30-mg LD Low Weight/Elderly	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at During Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort	30 days (n=69, n=63, n=69, n=78, n=47, n=48)	206.5 PRU	Standard Deviation 72.68
Prasugrel 30-mg LD Low Weight/Elderly	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at During Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort	90 Days (n=60, n=57, n=64, n=72, n=43, n=42)	188.3 PRU	Standard Deviation 81.24
Clopidogrel 300-mg LD Low Weight/Elderly	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at During Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort	30 days (n=69, n=63, n=69, n=78, n=47, n=48)	134.2 PRU	Standard Deviation 80.29
Clopidogrel 300-mg LD Low Weight/Elderly	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at During Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort	90 Days (n=60, n=57, n=64, n=72, n=43, n=42)	128.5 PRU	Standard Deviation 70.42
Clopidogrel 300/75 Low Weight/Elderly	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at During Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort	30 days (n=69, n=63, n=69, n=78, n=47, n=48)	237.5 PRU	Standard Deviation 108.32
Clopidogrel 300/75 Low Weight/Elderly	Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at During Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort	90 Days (n=60, n=57, n=64, n=72, n=43, n=42)	219.6 PRU	Standard Deviation 95.06

p-value: <0.000195% CI: [-166, -73]LS Mean Difference in PRU

p-value: <0.000195% CI: [-154, -73]Mixed Models Analysis

p-value: <0.000195% CI: [-121, -48]Mixed Models Analysis

p-value: 0.064795% CI: [-72, 2]Mixed Models Analysis

p-value: <0.000195% CI: [-143, -57]Mixed Models Analysis

Secondary

Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary

The primary hypothesis for the genetics substudy was that CYP2C19 genetic variation has a significant effect on pharmacodynamic (PD) response to clopidogrel but not on PD response to prasugrel per change in PRU as measured by the Accumetrics VerifyNow P2Y12 device. Participants were classified by CYP2C19 genotype into predicted metabolic phenotypes according to literature-based functional predictions. These classifications were clustered into 2 groups: extensive metabolizer (EM) and reduced metabolizer (RM). A higher value for change in PRU indicates a greater level of platelet inhibition.

Time frame: Baseline to 4 hours post-loading dose (LD), 30 days and 90 days during maintenance dose (MD) phase

Population: Pharmacodynamic analysis set is subset of FAS (≥1 genetics sample, ≥1 dose of study drug, ≥1 post-baseline PRU measurement, no significant protocol violations). Genetics subset LD population never used glycoprotein (GP) IIb/IIIa inhibitor during index hospitalization.~Participants classified as EM or RM. Invalid measurements of PRU were excluded.

Arm	Measure	Group	Value (MEAN)	Dispersion
Prasugrel 60-mg LD Primary	Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary	4 hours, EM (n=15, n=18, n=27, n=31)	-162.9 Change in PRU	Standard Deviation 154.3
Prasugrel 60-mg LD Primary	Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary	4 hours, RM (n=18, n=21, n=45, n=45)	-245.9 Change in PRU	Standard Deviation 102.77
Prasugrel 60-mg LD Primary	Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary	30 days, EM (n=17, n=21, n=31, n=30)	-193.9 Change in PRU	Standard Deviation 98.17
Prasugrel 60-mg LD Primary	Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary	30 days, RM (n=19, n=21. n=43, n=47)	-250.3 Change in PRU	Standard Deviation 90.17
Prasugrel 60-mg LD Primary	Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary	90 days, EM (n=12, n=18, n=30, n=28)	-203.8 Change in PRU	Standard Deviation 102.89
Prasugrel 60-mg LD Primary	Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary	90 days, RM (n=17, n=21, n=36, n=41)	-267.5 Change in PRU	Standard Deviation 70.86
Prasugrel 30-mg LD Primary	Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary	90 days, RM (n=17, n=21, n=36, n=41)	-225.7 Change in PRU	Standard Deviation 76.52
Prasugrel 30-mg LD Primary	Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary	30 days, RM (n=19, n=21. n=43, n=47)	-208.5 Change in PRU	Standard Deviation 74.23
Prasugrel 30-mg LD Primary	Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary	4 hours, EM (n=15, n=18, n=27, n=31)	-198.8 Change in PRU	Standard Deviation 90.71
Prasugrel 30-mg LD Primary	Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary	30 days, EM (n=17, n=21, n=31, n=30)	-196.5 Change in PRU	Standard Deviation 88.9
Prasugrel 30-mg LD Primary	Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary	4 hours, RM (n=18, n=21, n=45, n=45)	-183.3 Change in PRU	Standard Deviation 123.29
Prasugrel 30-mg LD Primary	Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary	90 days, EM (n=12, n=18, n=30, n=28)	-210.0 Change in PRU	Standard Deviation 110.68
Clopidogrel 300-mg LD Primary	Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary	4 hours, RM (n=18, n=21, n=45, n=45)	-181.9 Change in PRU	Standard Deviation 129.47
Clopidogrel 300-mg LD Primary	Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary	30 days, EM (n=17, n=21, n=31, n=30)	-187.5 Change in PRU	Standard Deviation 94.79
Clopidogrel 300-mg LD Primary	Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary	30 days, RM (n=19, n=21. n=43, n=47)	-152.8 Change in PRU	Standard Deviation 88.97
Clopidogrel 300-mg LD Primary	Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary	90 days, RM (n=17, n=21, n=36, n=41)	-164.1 Change in PRU	Standard Deviation 75.9
Clopidogrel 300-mg LD Primary	Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary	90 days, EM (n=12, n=18, n=30, n=28)	-187.2 Change in PRU	Standard Deviation 92.7
Clopidogrel 300-mg LD Primary	Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary	4 hours, EM (n=15, n=18, n=27, n=31)	-217.2 Change in PRU	Standard Deviation 83.52
Prasugrel 30-mg LD Low Weight/Elderly	Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary	90 days, EM (n=12, n=18, n=30, n=28)	-141.0 Change in PRU	Standard Deviation 75.58
Prasugrel 30-mg LD Low Weight/Elderly	Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary	90 days, RM (n=17, n=21, n=36, n=41)	-100.7 Change in PRU	Standard Deviation 92.24
Prasugrel 30-mg LD Low Weight/Elderly	Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary	4 hours, RM (n=18, n=21, n=45, n=45)	-22.2 Change in PRU	Standard Deviation 72.84
Prasugrel 30-mg LD Low Weight/Elderly	Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary	30 days, RM (n=19, n=21. n=43, n=47)	-81.7 Change in PRU	Standard Deviation 70.56
Prasugrel 30-mg LD Low Weight/Elderly	Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary	4 hours, EM (n=15, n=18, n=27, n=31)	-9.7 Change in PRU	Standard Deviation 72.3
Prasugrel 30-mg LD Low Weight/Elderly	Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary	30 days, EM (n=17, n=21, n=31, n=30)	-110.6 Change in PRU	Standard Deviation 83.49

Secondary

Incidence of CABG-related TIMI Major or Minor Bleeding.

Time frame: Randomization through end of study (90 days)

Population: Safety Analysis Set (SAS): all randomized participants with at least 1 dose of study drug~In 10 participants, study drug discontinued due to planned CABG. 1 participant had CABG reported on revascularization case report form (CRF); no reports of CABG bleeding event

Arm	Measure	Value (NUMBER)
Prasugrel 60-mg LD Primary	Incidence of CABG-related TIMI Major or Minor Bleeding.	0 participants
Prasugrel 30-mg LD Primary	Incidence of CABG-related TIMI Major or Minor Bleeding.	0 participants
Clopidogrel 300-mg LD Primary	Incidence of CABG-related TIMI Major or Minor Bleeding.	0 participants
Prasugrel 30-mg LD Low Weight/Elderly	Incidence of CABG-related TIMI Major or Minor Bleeding.	0 participants
Clopidogrel 300-mg LD Low Weight/Elderly	Incidence of CABG-related TIMI Major or Minor Bleeding.	0 participants
Clopidogrel 300/75 Low Weight/Elderly	Incidence of CABG-related TIMI Major or Minor Bleeding.	0 participants

Secondary

Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding

Bleeding events were classified and analyzed in accordance with the TIMI criteria definitions. Major bleeding: any intracranial hemorrhage (ICR) OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 grams/deciliter (gm/dL) from baseline. Minor bleeding: any clinically overt bleeding associated with a fall in Hgb of ≥3 but \<5 gm/dL from baseline. Insignificant bleeding: any bleeding event that does not meet criteria for a Major or Minor bleed.

Time frame: Randomization through end of study (90 days)

Population: Safety analysis set (SAS): all randomized participants with at least 1 dose of study drug~Two (2) participants had no event date; time from start of therapy to event was missing and thus they were not included in this table.

Arm	Measure	Group	Value (NUMBER)
Prasugrel 60-mg LD Primary	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	≤3 Days of LD Minor	1 participants
Prasugrel 60-mg LD Primary	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	≤3 Days of LD Life Threatening	2 participants
Prasugrel 60-mg LD Primary	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	≤3 Days of LD Major	2 participants
Prasugrel 60-mg LD Primary	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	≤3 Days of LD Minimal	5 participants
Prasugrel 60-mg LD Primary	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	>3 Days of LD Major	2 participants
Prasugrel 60-mg LD Primary	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	>3 Days of LD Life Threatening	0 participants
Prasugrel 60-mg LD Primary	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	>3 Days of LD Minor	0 participants
Prasugrel 60-mg LD Primary	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	>3 Days of LD Minimal	1 participants
Prasugrel 30-mg LD Primary	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	≤3 Days of LD Minimal	4 participants
Prasugrel 30-mg LD Primary	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	>3 Days of LD Minimal	2 participants
Prasugrel 30-mg LD Primary	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	≤3 Days of LD Major	0 participants
Prasugrel 30-mg LD Primary	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	>3 Days of LD Minor	0 participants
Prasugrel 30-mg LD Primary	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	>3 Days of LD Life Threatening	1 participants
Prasugrel 30-mg LD Primary	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	≤3 Days of LD Minor	0 participants
Prasugrel 30-mg LD Primary	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	≤3 Days of LD Life Threatening	0 participants
Prasugrel 30-mg LD Primary	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	>3 Days of LD Major	1 participants
Clopidogrel 300-mg LD Primary	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	≤3 Days of LD Life Threatening	0 participants
Clopidogrel 300-mg LD Primary	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	≤3 Days of LD Minor	2 participants
Clopidogrel 300-mg LD Primary	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	≤3 Days of LD Minimal	6 participants
Clopidogrel 300-mg LD Primary	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	>3 Days of LD Minimal	7 participants
Clopidogrel 300-mg LD Primary	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	>3 Days of LD Major	0 participants
Clopidogrel 300-mg LD Primary	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	>3 Days of LD Life Threatening	0 participants
Clopidogrel 300-mg LD Primary	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	>3 Days of LD Minor	0 participants
Clopidogrel 300-mg LD Primary	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	≤3 Days of LD Major	0 participants
Prasugrel 30-mg LD Low Weight/Elderly	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	>3 Days of LD Minor	0 participants
Prasugrel 30-mg LD Low Weight/Elderly	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	>3 Days of LD Life Threatening	0 participants
Prasugrel 30-mg LD Low Weight/Elderly	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	>3 Days of LD Major	0 participants
Prasugrel 30-mg LD Low Weight/Elderly	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	≤3 Days of LD Major	0 participants
Prasugrel 30-mg LD Low Weight/Elderly	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	≤3 Days of LD Minor	1 participants
Prasugrel 30-mg LD Low Weight/Elderly	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	≤3 Days of LD Minimal	4 participants
Prasugrel 30-mg LD Low Weight/Elderly	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	>3 Days of LD Minimal	3 participants
Prasugrel 30-mg LD Low Weight/Elderly	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	≤3 Days of LD Life Threatening	0 participants
Clopidogrel 300-mg LD Low Weight/Elderly	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	>3 Days of LD Minimal	2 participants
Clopidogrel 300-mg LD Low Weight/Elderly	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	≤3 Days of LD Major	2 participants
Clopidogrel 300-mg LD Low Weight/Elderly	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	>3 Days of LD Major	1 participants
Clopidogrel 300-mg LD Low Weight/Elderly	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	>3 Days of LD Life Threatening	1 participants
Clopidogrel 300-mg LD Low Weight/Elderly	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	>3 Days of LD Minor	0 participants
Clopidogrel 300-mg LD Low Weight/Elderly	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	≤3 Days of LD Life Threatening	2 participants
Clopidogrel 300-mg LD Low Weight/Elderly	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	≤3 Days of LD Minor	1 participants
Clopidogrel 300-mg LD Low Weight/Elderly	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	≤3 Days of LD Minimal	1 participants
Clopidogrel 300/75 Low Weight/Elderly	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	>3 Days of LD Minimal	3 participants
Clopidogrel 300/75 Low Weight/Elderly	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	>3 Days of LD Major	2 participants
Clopidogrel 300/75 Low Weight/Elderly	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	≤3 Days of LD Minor	0 participants
Clopidogrel 300/75 Low Weight/Elderly	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	≤3 Days of LD Minimal	1 participants
Clopidogrel 300/75 Low Weight/Elderly	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	>3 Days of LD Life Threatening	0 participants
Clopidogrel 300/75 Low Weight/Elderly	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	≤3 Days of LD Life Threatening	1 participants
Clopidogrel 300/75 Low Weight/Elderly	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	>3 Days of LD Minor	2 participants
Clopidogrel 300/75 Low Weight/Elderly	Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding	≤3 Days of LD Major	2 participants

Secondary

Inpatient Healthcare Resource Utilization

Healthcare resource utilization data were modeled from historical analyses to determine initial hospitalization costs, total 30-day medical care costs, and total 90-day medical care costs.

Time frame: Initial hospitalization, 30 days, 90 days

Population: As a consequence of the overall low number of reported clinical events, inpatient healthcare resource utilization data were not analyzed; thus zero participants were analyzed.

Secondary

Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort

A higher percentage (percent inhibition least squares mean \[LS mean\]) represents greater platelet inhibition.

Time frame: 30 minutes, 2 hours, and 4 hours following LD administration

Population: Per Protocol Set (PPS) LD population PPS: all randomized participants with at least 1 dose study drug, ≥1 post-baseline platelet aggregation measurement, no significant protocol violations LD population: never used glycoprotein (GP) IIb/IIIa inhibitor during index hospitalization, received percutaneous coronary intervention (PCI) for index event

Arm	Measure	Group	Value (NUMBER)
Prasugrel 60-mg LD Primary	Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort	2 hours (n=37, n=80, n=48, n=33, n=33)	49 Percent inhibition
Prasugrel 60-mg LD Primary	Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort	30 minutes (n=40, n=79, n=47, n=32, n=31)	10 Percent inhibition
Prasugrel 60-mg LD Primary	Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort	4 hours (n=34, n=79, n=43, n=33, n=33)	65 Percent inhibition
Prasugrel 30-mg LD Primary	Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort	30 minutes (n=40, n=79, n=47, n=32, n=31)	4 Percent inhibition
Prasugrel 30-mg LD Primary	Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort	4 hours (n=34, n=79, n=43, n=33, n=33)	51 Percent inhibition
Prasugrel 30-mg LD Primary	Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort	2 hours (n=37, n=80, n=48, n=33, n=33)	34 Percent inhibition
Clopidogrel 300-mg LD Primary	Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort	30 minutes (n=40, n=79, n=47, n=32, n=31)	-5 Percent inhibition
Clopidogrel 300-mg LD Primary	Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort	2 hours (n=37, n=80, n=48, n=33, n=33)	-2 Percent inhibition
Clopidogrel 300-mg LD Primary	Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort	4 hours (n=34, n=79, n=43, n=33, n=33)	4 Percent inhibition
Prasugrel 30-mg LD Low Weight/Elderly	Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort	4 hours (n=34, n=79, n=43, n=33, n=33)	63 Percent inhibition
Prasugrel 30-mg LD Low Weight/Elderly	Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort	30 minutes (n=40, n=79, n=47, n=32, n=31)	11 Percent inhibition
Prasugrel 30-mg LD Low Weight/Elderly	Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort	2 hours (n=37, n=80, n=48, n=33, n=33)	51 Percent inhibition
Clopidogrel 300-mg LD Low Weight/Elderly	Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort	2 hours (n=37, n=80, n=48, n=33, n=33)	2 Percent inhibition
Clopidogrel 300-mg LD Low Weight/Elderly	Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort	30 minutes (n=40, n=79, n=47, n=32, n=31)	0 Percent inhibition
Clopidogrel 300-mg LD Low Weight/Elderly	Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort	4 hours (n=34, n=79, n=43, n=33, n=33)	7 Percent inhibition

p-value: 0.007295% CI: [4, 27]Mixed Models Analysis

p-value: 0.064795% CI: [-1, 18]Mixed Models Analysis

p-value: 0.005495% CI: [3, 19]Mixed Models Analysis

p-value: <0.000195% CI: [36, 66]Mixed Models Analysis

p-value: <0.000195% CI: [23, 48]Mixed Models Analysis

p-value: <0.000195% CI: [36, 61]Mixed Models Analysis

p-value: <0.000195% CI: [47, 76]Mixed Models Analysis

p-value: <0.000195% CI: [36, 59]Mixed Models Analysis

p-value: <0.000195% CI: [44, 68]Mixed Models Analysis

Secondary

Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) During the Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort

A higher percentage (percent inhibition least squares mean \[LS mean\]) represents greater platelet inhibition.

Time frame: 30 days and at 90 days during MD therapy

Population: Per Protocol Set (PPS) MD population~PPS: all randomized participants who had at least 1 dose of study drug, ≥1 post-baseline platelet aggregation measurement, and no significant protocol violations~MD population: received percutaneous coronary intervention (PCI) for index event

Arm	Measure	Group	Value (NUMBER)
Prasugrel 60-mg LD Primary	Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) During the Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort	90 Days (n=60, n=57, n=64, n=72, n=43, n=42)	73 Percent inhibition
Prasugrel 60-mg LD Primary	Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) During the Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort	30 Days (n=69, n=63, n=68, n=78, n=47, n=48)	67 Percent inhibition
Prasugrel 30-mg LD Primary	Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) During the Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort	90 Days (n=60, n=57, n=64, n=72, n=43, n=42)	66 Percent inhibition
Prasugrel 30-mg LD Primary	Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) During the Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort	30 Days (n=69, n=63, n=68, n=78, n=47, n=48)	60 Percent inhibition
Clopidogrel 300-mg LD Primary	Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) During the Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort	30 Days (n=69, n=63, n=68, n=78, n=47, n=48)	45 Percent inhibition
Clopidogrel 300-mg LD Primary	Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) During the Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort	90 Days (n=60, n=57, n=64, n=72, n=43, n=42)	48 Percent inhibition
Prasugrel 30-mg LD Low Weight/Elderly	Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) During the Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort	30 Days (n=69, n=63, n=68, n=78, n=47, n=48)	29 Percent inhibition
Prasugrel 30-mg LD Low Weight/Elderly	Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) During the Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort	90 Days (n=60, n=57, n=64, n=72, n=43, n=42)	38 Percent inhibition
Clopidogrel 300-mg LD Low Weight/Elderly	Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) During the Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort	30 Days (n=69, n=63, n=68, n=78, n=47, n=48)	68 Percent inhibition
Clopidogrel 300-mg LD Low Weight/Elderly	Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) During the Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort	90 Days (n=60, n=57, n=64, n=72, n=43, n=42)	69 Percent inhibition
Clopidogrel 300/75 Low Weight/Elderly	Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) During the Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort	90 Days (n=60, n=57, n=64, n=72, n=43, n=42)	38 Percent inhibition
Clopidogrel 300/75 Low Weight/Elderly	Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) During the Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort	30 Days (n=69, n=63, n=68, n=78, n=47, n=48)	32 Percent inhibition

p-value: <0.000195% CI: [27, 50]Mixed Models Analysis

p-value: <0.000195% CI: [21, 42]Mixed Models Analysis

p-value: 0.002695% CI: [6, 28]Mixed Models Analysis

p-value: <0.000195% CI: [24, 50]Mixed Models Analysis

p-value: 0.000195% CI: [18, 52]Mixed Models Analysis

p-value: 0.000595% CI: [13, 44]Mixed Models Analysis

p-value: 0.189895% CI: [-5, 27]Mixed Models Analysis

p-value: <0.000195% CI: [18, 45]Mixed Models Analysis

Secondary

Risk of All-cause Death in Primary Cohort and Low Weight/Elderly Cohort

Risk was defined as the number of participants with events of all-cause death.

Time frame: Randomization through end of study (90 days)

Population: Full Analysis Set (FAS): all randomized subjects who received at least 1 dose of study drug

Arm	Measure	Value (NUMBER)
Prasugrel 60-mg LD Primary	Risk of All-cause Death in Primary Cohort and Low Weight/Elderly Cohort	5 Participants
Prasugrel 30-mg LD Primary	Risk of All-cause Death in Primary Cohort and Low Weight/Elderly Cohort	4 Participants
Clopidogrel 300-mg LD Primary	Risk of All-cause Death in Primary Cohort and Low Weight/Elderly Cohort	3 Participants
Prasugrel 30-mg LD Low Weight/Elderly	Risk of All-cause Death in Primary Cohort and Low Weight/Elderly Cohort	2 Participants
Clopidogrel 300-mg LD Low Weight/Elderly	Risk of All-cause Death in Primary Cohort and Low Weight/Elderly Cohort	7 Participants
Clopidogrel 300/75 Low Weight/Elderly	Risk of All-cause Death in Primary Cohort and Low Weight/Elderly Cohort	1 Participants

p-value: 0.255Fisher Exact

p-value: 0.427Fisher Exact

p-value: 0.683Fisher Exact

p-value: 0.034Fisher Exact

Secondary

Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Recurrent Myocardial Ischemia Requiring Hospitalization

Risk was defined as the number of events of CV death, nonfatal MI, nonfatal stroke or recurrent myocardial ischemia requiring hospitalization. Recurrent myocardial ischemia requiring hospitalization: rehospitalization for symptoms of myocardial ischemia at rest with either new ST-segment deviation ≥1 mm, or performance of a coronary revascularization procedure percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) during the same hospital stay. As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed.

Time frame: 30 days and 90 days