Clopidogrel/Aspirin Interaction Study
Information source: Population Health Research Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease
Intervention: Clopidogrel (Drug); Clopidogrel (Drug); Aspirin (Drug); Aspirin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Population Health Research Institute Official(s) and/or principal investigator(s): Yan Liang, MD, Principal Investigator, Affiliation: Population Health Research Institute John Eikelboom, MD., Study Director, Affiliation: Population Health Research Institute
Summary
This study will explore the effect of different doses of aspirin on the effects of
double-dose or standard dose clopidogrel.
Clinical Details
Official title: Randomized, Factorial Study to Explore Interaction Between Aspirin and Clopidogrel in Stable Patients With Previous Myocardial Infarction or Coronary Artery Stent
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Blood concentrations of the active metabolite of clopidogrel
Secondary outcome: Inhibition of adenosine diphosphate (ADP) induced platelet aggregation
Detailed description:
Study Hypothesis: Patients receiving double-dose compared with standard-dose clopidogrel
will have increased blood concentrations of the active metabolite of clopidogrel and greater
inhibition of ADP-induced platelet aggregation when also treated with acetylsalicylic acid
(ASA) 325 mg/d as compared to ASA 81 mg/d.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- > 1 month post myocardial infarction (MI), unstable angina or stent patients with
stable condition
- Receiving regular ASA (81mg/d) and clopidogrel (75mg/d) for at least 1 week
- Written informed consent
Exclusion Criteria:
- Age < 18 years old
- Liver disease with transaminases and/or bilirubin > 1. 5x upper limits of normal (ULN)
(within 3 months of randomization)
- Renal impairment with creatinine clearance < 30 ml/min (within 3 months of
randomization)
- Platelet count < 100x109/L and/or Hb< 100g/L (within 3 months of randomization)
- Use of oral anticoagulants or nonsteroidal antiinflammatory drug (NSAID) within the
last 10 days or planned use during the study
- Use of antiplatelet agent other than aspirin and clopidogrel within the last 10 days
- High risk of bleeding (e. g. recent gastrointestinal bleeding, bleeding diathesis)
- Uncontrolled hypertension (> 180/110mmHg)
- Current smoker with ≥ 5 cigarettes/day
- Previously entered in this study or just finished other study within 2 weeks before
recruitment
- Medical, geographic, or social factors making study participation impractical, or
inability to provide written informed consent
Locations and Contacts
Population Health Research Institute, Hamilton, Ontario L8L 2X2, Canada
Additional Information
Starting date: April 2010
Last updated: April 27, 2015
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