Status:
COMPLETED
Evaluation of the Influence of Statins and Proton Pump Inhibitors on Clopidogrel Antiplatelet Effects
Lead Sponsor:
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
There is conflicting evidence in the literature suggesting that the use of proton pump inhibitors (PPIs), and/or some statins can interfere with clopidogrel antiplatelet effect and result in adverse c...
Eligibility Criteria
Inclusion
- Subject must be 18 years of age or older
- Bare metal stent implantation
- Discharged with dual antiplatelet therapy for at least 60 days
- Written informed consent
Exclusion
- Patients who do not consent to participate in the study
- Premenopausal women not using contraceptive methods or without a negative pregnancy test in the past week
- Patients treated or planned to be treated with oral anticoagulants
- Present treatment with or clear indication for treatment with a PPI or H2 antagonists
- Allergy or intolerance to study medications including ranitidine, Proton pump inhibitors, atorvastatin, rosuvastatin, aspirin and/or clopidogrel
- Patient treated with a strong CYP2C19 interacting drug
- History of a bleeding diathesis, or evidence of active abnormal bleeding within 30 days before enrollment
- History of intracranial hemorrhage or intracranial surgery in the last 3 months
- History of gastro-intestinal ulcers in the last 3 months
- Any serious illness or any condition that the investigator feels would influence the impact of this therapy on the subject
- Known platelet count \< 100000/mm3 at time of enrollment or within 24 hours prior to enrollment
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT00930670
Start Date
June 1 2009
End Date
December 1 2011
Last Update
February 9 2012
Active Locations (1)
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1
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec, Canada, G1V4G5