Testing Platelet Reactivity In Patients Undergoing Elective Stent Placement on Clopidogrel to Guide Alternative Therapy With Prasugrel (TRIGGER-PCI)

• Number of Participants With Stent Thrombosis (ST) [ Time Frame: Baseline through 6 months ] [ Designated as safety issue: No ]
  Academic Research Consortium (ARC) criteria was used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least one of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause.
• Number of Participants With Composite Endpoint of All-Cause Death or Myocardial Infarction (MI) [ Time Frame: Baseline through 6 months ] [ Designated as safety issue: No ]
  The endpoint in this measure is a combination of all-cause death or MI.

• The time to first occurrence of stent thrombosis. [ Time Frame: Through 6 months. ] [ Designated as safety issue: No ]
• The time to first occurrence of all-cause death or myocardial infarction. [ Time Frame: Through 6 months. ] [ Designated as safety issue: No ]

To determine the efficacy of prasugrel versus clopidogrel for the reduction of adverse cardiovascular outcomes in patients with high platelet reactivity on clopidogrel after successful implantation of coronary drug-eluting stents.

To determine the adverse event profile of prasugrel in patients with high platelet reactivity on clopidogrel after implantation of coronary drug-eluting stents.

To determine the effect of prasugrel on inhibition of platelet activation in patients with high platelet reactivity on clopidogrel.

• Drug: Prasugrel
  One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months.
  Other Names:

  • LY640315
  • Effient
  • Efient
• Drug: Clopidogrel
  75 mg oral daily maintenance dose up to 6 months.

• Experimental: Prasugrel
  Intervention: Drug: Prasugrel
• Active Comparator: Clopidogrel
  Intervention: Drug: Clopidogrel

Key Inclusion Criteria:

• Have coronary artery disease and clinical indication for percutaneous coronary intervention (PCI) with implantation of at least one drug-eluting stent and where percutaneous coronary intervention of all treated lesions is successful.
• Have been given standard-of-care clopidogrel 600-mg loading dose between 24 hours before and at the time of PCI.
• Standard of Care Aspirin use prior to PCI - at least 250-mg [intravenous (IV) or oral] within 24 hours before PCI and at the time of PCI.
• VerifyNow P2Y12 reaction units > 208 measured 2-7 hours after clopidogrel maintenance dose the day after successful PCI.

Exclusion Criteria:

• Non-ST segment elevation myocardial infarction within 14 days prior to randomization
• ST-segment elevation myocardial infarction within 14 days prior to randomization
• Have known major complications after percutaneous coronary intervention and prior to randomization
• Have a body weight < 60 kilogram (kg)
• Have cardiogenic shock at time of randomization
• Have refractory ventricular arrhythmias
• Have New York Heart Association Class IV congestive heart failure
• Have received glycoprotein (GP) IIb/IIIa inhibitors eptifibatide or tirofiban within 24 hrs before or during percutaneous coronary intervention or abciximab within 10 days before or during percutaneous coronary intervention
• Are receiving daily treatment with nonsteroidal anti-inflammatory drug (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued or are anticipated to require > 2 weeks of daily treatment during the study