Testing Platelet Reactivity In Patients Undergoing Elective Stent Placement on Clopidogrel to Guide Alternative Therapy With Prasugrel (TRIGGER-PCI)
Condition: Coronary Artery Disease (CAD)
MeSH terms: Coronary Artery Disease
Intervention: Prasugrel; Clopidogrel
Intervention description: One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months.; 75 mg oral daily maintenance dose up to 6 months.
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 423.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Clopidogrel; VerifyNow; PRU Measurements; Drug Eluting Stents (DES); Heart Disease; Percutaneous Coronary Intervention (PCI); P2Y12; Platelets; Platelet Reactivity

Summary:

      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.
    

Eligibility criteria:

        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