Clopidogrel/Aspirin Interaction Study

Population Health Research Institute82 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Coronary Artery Disease

Interventions

ClopidogrelDRUG

300 mg loading dose, then 75 mg daily

ClopidogrelDRUG

600 mg loading dose, 150 mg daily day 2-7, then 75 mg daily

AspirinDRUG

81 mg daily

Aspirin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (1)

Population Health Research Institute

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

Blood concentrations of the active metabolite of clopidogrel

Time frame: 14 days

Secondary Outcomes

Inhibition of adenosine diphosphate (ADP) induced platelet aggregation

Time frame: 14 days

Data from ClinicalTrials.gov

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