Clopidogrel and Response Variability Investigation Study 2

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Male

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 following an oral administration of a loading dose of 300/900mg of clopidogrel in patients with established coronary artery disease.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Institut National de la Santé Et de la Recherche Médicale, France
• Treatments: Clopidogrel; Ticlopidine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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