Status:
TERMINATED
Genotype Guided Comparison of Clopidogrel and Prasugrel Outcomes Study
Lead Sponsor:
Medco Health Solutions, Inc.
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
18-75 years
Brief Summary
The primary objective of this trial is to demonstrate the non-inferiority of clopidogrel compared to prasugrel over 6 months in cardiovascular disease patients when the clopidogrel cohort is limited t...
Detailed Description
This is a prospective, non-randomized, open-label, non-inferiority comparative effectiveness outcomes trial comparing clopidogrel EMs (confirmed by CYP2C19 genotype)and receiving clopidogrel at 75 mg/...
Eligibility Criteria
Inclusion
- Men and women between 18 years and 75 years of age
- Recent prescription for clopidogrel or prasugrel.
- Participant is willing and able to provide informed consent.
Exclusion
- Previous use of any thienopyridine within 4 months of initiating new clopidogrel or prasugrel therapy.
- Participant refusal to participate in the study.
- Anticipated discontinuation of clopidogrel or prasugrel within the 6 month study follow-up period
- Participants that have previously stated "do not contact"
Key Trial Info
Start Date :
October 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
4471 Patients enrolled
Trial Details
Trial ID
NCT00995514
Start Date
October 1 2009
End Date
May 1 2012
Last Update
May 30 2012
Active Locations (1)
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1
Medco Health Solutions, Inc
Franklin Lakes, New Jersey, United States, 07417