Status:
COMPLETED
Clopidogrel and Response Variability Investigation Study 2
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Coronary Artery Disease
Eligibility:
MALE
18-75 years
Phase:
PHASE3
Brief Summary
To evaluate the role of the genetic variant 2C19\*2 on the pharmacodynamic response as assessed by optical aggregometry and on the pharmacokinetic response as assessed by measuring active metabolites ...
Detailed Description
Rationale : Clopidogrel is a specific and irreversible of the P2Y12 platelet receptor leading to an inhibition of platelet aggregation. Clopidogrel is a prodrug that must be converted into an active m...
Eligibility Criteria
Inclusion
- Age \> 18
- Male gender
- Included in the AFIJI registry
- No high bleeding risk profile
- No recent history of acute coronary syndrome (\< 3 months)
- Written informed consent obtained
- Genotype CYP2C19 : \*1/\*1, \*1/\*2 ou \*2/\*2
- Genotype P2Y12 : H1/H1 ou H1/H2
Exclusion
- Female gender
- Patient with a contraindication to clopidogrel
- Patient who has received a loading dose of clopidogrel in the past 7 days
- Patient treated with ticlopidine or GP2B/3A receptor antagonist prior to loading
- Non compliance
- Génotype P2Y12 : H2/H2.
- Patient treated with drugs interacting with platelet aggregation (NSAID, persantine, serotonin inhibitors )
- Patient treated with drugs interacting 2C19
- Not affiliated to the national health insurance
- Patient participating to another randomized study
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT00822666
Start Date
October 1 2008
End Date
December 1 2009
Last Update
December 11 2012
Active Locations (1)
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1
Hopital la Pitié-Salpétrière Institut de cardiologie
Paris, France, 75013