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

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of Prasugrel Versus Clopidogrel in Subjects With High Platelet Reactivity on Clopidogrel Following Elective Percutaneous Coronary Intervention With Implantation of Drug-Eluting Stent

Conditions
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Coronary Artery Disease (CAD)

Intervention / Treatment
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* Drug: Prasugrel
* Drug: Clopidogrel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prasugrel<br> | Drug: Prasugrel<br>* One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months.<br>* Other names: Efient;|
| Active Comparator: Clopidogrel<br> | Drug: Clopidogrel<br>* 75 mg oral daily maintenance dose up to 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Composite Endpoint of Cardiovascular Death or Myocardial Infarction (MI) | The endpoint in this measure is a combination of cardiovascular death or MI. | Baseline through 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Stent Thrombosis (ST) | 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. | Baseline through 6 months | 
| Number of Participants With Composite Endpoint of All-Cause Death or Myocardial Infarction (MI) | The endpoint in this measure is a combination of all-cause death or MI. | Baseline through 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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P2Y12, Clopidogrel, VerifyNow, PRU Measurements, Drug Eluting Stents (DES), Heart Disease, Percutaneous Coronary Intervention (PCI), Platelets, Platelet Reactivity