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

• Status: Terminated
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Daiichi Sankyo Co., Ltd.
• Treatments: Clopidogrel; Prasugrel Hydrochloride; Ticlopidine

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