Testing Platelet Reactivity In Patients Undergoing Elective Stent Placement on Clopidogrel to Guide Alternative Therapy With Prasugrel (TRIGGER-PCI)
NCT ID: NCT00910299
Last Updated: 2012-06-08
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
423 participants
INTERVENTIONAL
2009-07-31
2011-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Prasugrel
Prasugrel
One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months.
Clopidogrel
Clopidogrel
75 mg oral daily maintenance dose up to 6 months.
Interventions
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Prasugrel
One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months.
Clopidogrel
75 mg oral daily maintenance dose up to 6 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Daiichi Sankyo Co., Ltd.
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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.
Clearwater, Florida, United States
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Jacksonville, Florida, United States
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Rome, Georgia, United States
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Moline, Illinois, United States
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New York, New York, United States
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Portland, Oregon, United States
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Pittsburgh, Pennsylvania, United States
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Rapid City, South Dakota, United States
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Nashville, Tennessee, United States
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Bad Berka, , Germany
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Bad Krozingen, , Germany
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Bad Segeberg, , Germany
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Berlin, , Germany
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Bremen, , Germany
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Dortmund, , Germany
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Essen, , Germany
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Freiburg im Breisgau, , Germany
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Fulda, , Germany
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Hamburg, , Germany
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Leipzig, , Germany
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Mainz, , Germany
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Munich, , Germany
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Pforzheim, , Germany
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Stuttgart, , Germany
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Tübingen, , Germany
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Villingen-Schwenningen, , Germany
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Wuppertal, , Germany
Countries
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References
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Trenk D, Stone GW, Gawaz M, Kastrati A, Angiolillo DJ, Muller U, Richardt G, Jakubowski JA, Neumann FJ. A randomized trial of prasugrel versus clopidogrel in patients with high platelet reactivity on clopidogrel after elective percutaneous coronary intervention with implantation of drug-eluting stents: results of the TRIGGER-PCI (Testing Platelet Reactivity In Patients Undergoing Elective Stent Placement on Clopidogrel to Guide Alternative Therapy With Prasugrel) study. J Am Coll Cardiol. 2012 Jun 12;59(24):2159-64. doi: 10.1016/j.jacc.2012.02.026. Epub 2012 Apr 18.
Other Identifiers
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H7T-MC-TACW
Identifier Type: OTHER
Identifier Source: secondary_id
12323
Identifier Type: -
Identifier Source: org_study_id
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