Clopidogrel/Aspirin Interaction Study

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will explore the effect of different doses of aspirin on the effects of double-dose or standard dose clopidogrel.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Population Health Research Institute
• Treatments: Aspirin; Clopidogrel; Ticlopidine

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