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

Eli Lilly and Company1 site in 1 country423 target enrollmentJuly 2009

ConditionsCoronary Artery Disease (CAD)

InterventionsPrasugrel Clopidogrel

DrugsPrasugrel Clopidogrel

Overview

Phase: Phase 2
Intervention: Prasugrel
Conditions: Coronary Artery Disease (CAD)
Sponsor: Eli Lilly and Company
Enrollment: 423
Locations: 1
Primary Endpoint: Number of Participants With Composite Endpoint of Cardiovascular Death or Myocardial Infarction (MI)
Status: Terminated
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2009

End Date

April 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Prasugrel

Intervention: Prasugrel

Clopidogrel

Intervention: Clopidogrel

Outcomes

Primary Outcomes

Number of Participants With Composite Endpoint of Cardiovascular Death or Myocardial Infarction (MI)

Time Frame: Baseline through 6 months

The endpoint in this measure is a combination of cardiovascular death or MI.

Secondary Outcomes

Number of Participants With Stent Thrombosis (ST)(Baseline through 6 months)
Number of Participants With Composite Endpoint of All-Cause Death or Myocardial Infarction (MI)(Baseline through 6 months)