Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
82 participants
INTERVENTIONAL
2010-04-30
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Standard dose clopidogrel
300 mg Loading x 1 day, 75 mg/d x 13 days
Clopidogrel
300 mg loading dose, then 75 mg daily
Double dose clopidogrel
600 mg Loading x 1 day, 150 mg/d x 6 days, 75 mg/d x 7 days
Clopidogrel
600 mg loading dose, 150 mg daily day 2-7, then 75 mg daily
Standard dose aspirin
Aspirin 81mg/d x 14 days
Aspirin
81 mg daily
High dose aspirin
Aspirin 325 mg/d x 14 days
Aspirin
325 mg daily
Interventions
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Clopidogrel
300 mg loading dose, then 75 mg daily
Clopidogrel
600 mg loading dose, 150 mg daily day 2-7, then 75 mg daily
Aspirin
81 mg daily
Aspirin
325 mg daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Receiving regular ASA (81mg/d) and clopidogrel (75mg/d) for at least 1 week
* Written informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Population Health Research Institute
OTHER
Responsible Party
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John Eikelboom
MD.
Principal Investigators
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Yan Liang, MD
Role: PRINCIPAL_INVESTIGATOR
Population Health Research Institute
John Eikelboom, MD.
Role: STUDY_DIRECTOR
Population Health Research Institute
Locations
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Population Health Research Institute
Hamilton, Ontario, Canada
Countries
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Other Identifiers
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10-082
Identifier Type: -
Identifier Source: org_study_id
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