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.

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

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.

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

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.

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

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

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

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

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

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

Full analysis set (FAS)

FAS: all randomized subjects who received at least 1 dose of study drug

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.

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

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.

As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.

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.

As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.

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.

As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.

Risk was defined as the number of participants with events of CV death, nonfatal MI, nonfatal stroke, UTVR, or recurrent myocardial ischemia requiring hospitalization.

As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.

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.

As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.

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.

As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.

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

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

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.

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.

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

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.

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.

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.

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.

Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Urgent Target Vessel Revascularization (UTVR), or Recurrent Myocardial Ischemia Requiring Hospitalization (Analyzed Individually)

As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.