Testing Platelet Reactivity In Patients Undergoing Elective Stent Placement on Clopidogrel to Guide Alternative Therapy With Prasugrel (TRIGGER-PCI)
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.
Coronary Artery Disease (CAD)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effectiveness of Prasugrel Versus Clopidogrel in Subjects With High Platelet Reactivity on Clopidogrel Following Elective Percutaneous Coronary Intervention With Implantation of Drug-Eluting Stent|
- Number of Participants With Composite Endpoint of Cardiovascular Death or Myocardial Infarction (MI) [ Time Frame: Baseline through 6 months ] [ Designated as safety issue: No ]The endpoint in this measure is a combination of cardiovascular death or MI.
- Number of Participants With Stent Thrombosis (ST) [ Time Frame: Baseline through 6 months ] [ Designated as safety issue: No ]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) [ Time Frame: Baseline through 6 months ] [ Designated as safety issue: No ]The endpoint in this measure is a combination of all-cause death or MI.
|Study Start Date:||July 2009|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months.
|Active Comparator: Clopidogrel||
75 mg oral daily maintenance dose up to 6 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00910299
|United States, Florida|
|Clearwater, Florida, United States, 33756|
|Jacksonville, Florida, United States, 32209|
|United States, Georgia|
|Rome, Georgia, United States, 30165|
|United States, Illinois|
|Moline, Illinois, United States, 61265|
|United States, New York|
|New York, New York, United States, 10021|
|United States, Oregon|
|Portland, Oregon, United States, 97225|
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, South Dakota|
|Rapid City, South Dakota, United States, 55701|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|Bad Berka, Germany, 99437|
|Bad Krozingen, Germany, 79189|
|Bad Segeberg, Germany, 23795|
|Berlin, Germany, 12203|
|Bremen, Germany, 28277|
|Dortmund, Germany, 44137|
|Essen, Germany, 45147|
|Freiburg, Germany, 79106|
|Fulda, Germany, 36043|
|Hamburg, Germany, 20246|
|Leipzig, Germany, 04289|
|Mainz, Germany, 55131|
|Munich, Germany, 80636|
|Pforzheim, Germany, 75175|
|Stuttgart, Germany, 70376|
|Tuebingen, Germany, 72076|
|Villingen-Schwenningen, Germany, 78050|
|Wuppertal, Germany, 42117|
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|