H2 Haplotype and CYP3As Polymorphisms and the Antiplatelet Response to Clopidogrel
Evaluation of the Effect of the H2 Haplotype and CYP3As Polymorphisms on the Antiplatelet Response to Clopidogrel Given Before Elective Percutaneous Coronary Intervention
1 other identifier
interventional
120
1 country
1
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 clopidogrel-P2Y12 receptor genes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 coronary-artery-disease
Started Sep 2004
Shorter than P25 for phase_4 coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 8, 2007
CompletedFirst Posted
Study publicly available on registry
February 12, 2007
CompletedAugust 21, 2012
June 1, 2008
February 8, 2007
August 20, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of CYP3A5 polymorphisms and of the H2 haplotype on the inhibitory effect of clopidogrel on platelet aggregation at the time of diagnostic coronary angiography as measured by optical aggregometry with adenosine diphosphate (ADP) 20 μmol/L
Interventions
Eligibility Criteria
You may qualify if:
- Documented coronary artery disease (CAD) requiring an elective diagnostic coronary angiography with or without percutaneous coronary intervention (PCI)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, H4J 1C5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean G Diodati, MD
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 8, 2007
First Posted
February 12, 2007
Study Start
September 1, 2004
Study Completion
April 1, 2006
Last Updated
August 21, 2012
Record last verified: 2008-06