Status:
COMPLETED
ReAssessment of Anti-Platelet Therapy Using an InDividualized Strategy Based on GENetic Evaluation
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Collaborating Sponsors:
Spartan Bioscience Inc.
Conditions:
Stable Coronary Artery Disease
Acute Coronary Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
The objective of the RAPID GENE study is to evaluate the feasibility, efficacy and safety of a pharmacogenomic approach to anti-platelet therapy following coronary artery stenting using a CYP2C19\*2 p...
Detailed Description
Effective medical treatment following acute coronary syndromes and percutaneous coronary intervention (PCI) consists of dual anti-platelet therapy with aspirin and clopidogrel. Despite this treatment ...
Eligibility Criteria
Inclusion
- Males and Females between the ages of 18 and 75 years
- Patients undergoing percutaneous coronary intervention in the context of a non-ST-elevation acute coronary syndrome or stable coronary artery disease
- Able to provide informed consent
- Able to comply with assigned treatment strategy and attend 1 week follow-up visit
Exclusion
- Receiving anti-platelet therapy other than aspirin and clopidogrel
- Receiving anti-coagulation with warfarin
- History of stroke or transient ischemic attack
- Platelet count \< 100 000/μL
- Known Bleeding Diathesis
- Hematocrit \<32% or \>52%
- Severe Liver Dysfunction
- Renal Insufficiency (Creatinine Clearance \< 30ml/min)
- Pregnant females
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01184300
Start Date
August 1 2010
End Date
July 1 2011
Last Update
November 11 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7