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

Phase 2

Terminated

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Prasugrel	Prasugrel	-
Clopidogrel	Clopidogrel	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Composite Endpoint of Cardiovascular Death or Myocardial Infarction (MI)	Baseline through 6 months	The endpoint in this measure is a combination of cardiovascular death or MI.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Stent Thrombosis (ST)	Baseline through 6 months	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)	Baseline through 6 months	The endpoint in this measure is a combination of all-cause death or MI.

Locations (1): For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wuppertal, Germany