Status:
COMPLETED
H2 Haplotype and CYP3As Polymorphisms and the Antiplatelet Response to Clopidogrel
Lead Sponsor:
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Conditions:
Coronary Artery Disease
Elective Percutaneous Coronary Intervention
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study was to assess whether interpatient variability in the platelet response to clopidogrel is partly due to polymorphisms of the hepatic cytochrome P450 (CYP450)3A and of the clo...
Detailed Description
Clopidogrel owes its antiplatelet effect to irreversible inhibition of the purinergic platelet receptor, P2Y12. It is estimated that approximately 4%-30% of patients treated with conventional doses of...
Eligibility Criteria
Inclusion
- Documented coronary artery disease (CAD) requiring an elective diagnostic coronary angiography with or without percutaneous coronary intervention (PCI)
Exclusion
- Major bleeding disorders or active bleeding;
- Acute MI within 14 days of recruitment;
- Unstable angina with ST-segment changes of \> or = 1 mm in at least two contiguous electrocardiographic leads at rest, a troponin level of \> 0.06 ug/L or both within 14 days of recruitment;
- Stroke within the last 3 months;
- Platelet count \< 100 x 109/L;
- Prothrombin time \> 1.5 times control;
- Hematocrit \< 25% or hemoglobin level \< 100 g/L;
- Alcohol or drug abuse;
- Enrolment in other investigational drug trials within the previous month;
- Use of thienopyridines, glycoprotein (GP) IIb/IIIa inhibitors, warfarin or acenocoumarol within the prior week;
- Allergic reaction or any contraindication to clopidogrel or aspirin.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00433784
Start Date
September 1 2004
End Date
April 1 2006
Last Update
August 21 2012
Active Locations (1)
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1
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, Canada, H4J 1C5