Status:
TERMINATED
Testing Platelet Reactivity In Patients Undergoing Elective Stent Placement on Clopidogrel to Guide Alternative Therapy With Prasugrel (TRIGGER-PCI)
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Daiichi Sankyo Co., Ltd.
Conditions:
Coronary Artery Disease (CAD)
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
423 Patients enrolled
Trial Details
Trial ID
NCT00910299
Start Date
July 1 2009
End Date
April 1 2011
Last Update
June 8 2012
Active Locations (27)
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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.
Clearwater, Florida, United States, 33756
2
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.
Jacksonville, Florida, United States, 32209
3
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.
Rome, Georgia, United States, 30165
4
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.
Moline, Illinois, United States, 61265