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Interaction2: Clopidogrel and Aspirin Interaction Study-2

Sponsor
Population Health Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01341964
Collaborator
(none)
220
Enrollment
1
Location
2
Arms
23
Duration (Months)
9.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Clopidogrel and aspirin are commonly used in combination to prevent heart attacks and to prevent blockage of stents. Both clopidogrel and aspirin work by preventing platelets (sticky cells that circulate in the blood) from forming blood clots in the arteries supplying oxygen to the heart and in stents. The investigators hypothesize that aspirin 325mg compared with aspirin 81 mg will increase blood levels of the active metabolite of clopidogrel in patients with a history of coronary artery disease who receive a 600mg loading dose of clopidogrel.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Eligible patients will be randomized to receive clopidogrel 600mg + aspirin 325mg (Group A) or clopidogrel 600mg + aspirin 81mg (Group B). Patients will be fasted for at least 8 hours prior to study drug administration. Blood samples will be collected at 1 hour after study drug administration for measurement of clopidogrel active metabolite levels and genotyping.

Study Design

Study Type:
Interventional
Actual Enrollment :
220 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Controlled Trial to Explore Interaction Between Aspirin and Clopidogrel in Stable Patients With Previous Myocardial Infarction or Coronary Artery Stent
Study Start Date :
May 1, 2011
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
Apr 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Higher dose aspirin group

Clopidogrel 600 mg plus aspirin 325mg

Drug: Clopidogrel
600mg (2 pills)
Other Names:
  • Plavix

    • Drug: Aspirin
    325mg (1 pill)
    Other Names:
  • Novasen

    		•
    Active Comparator: Low dose aspirin group

    Clopidogrel 600mg plus aspirin 81mg

    Drug: Clopidogrel
    600mg (2 pills)
    Other Names:
  • Plavix

    • Drug: Aspirin
    81mg (1 pill)
    Other Names:
  • Entrophen

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Blood concentration of the active metabolite of clopidogrel [1 hour after loading dose of study medications]

      Clopidogrel active metabolite concentration will be measured by liquid chromatography tandem mass spectrometry (LC/MS) methods.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Stable patients >1 month post ACS (including ST elevated myocardial infarction, non-ST elevated myocardial infarction or unstable angina) or stent

    • Receiving regular ASA (81mg/d) and clopidogrel (75mg/d) for at least 1 week

    • Written informed consent

    Exclusion Criteria:

    • Age < 18 years

    • Liver disease with ALT or bilirubin >2x upper limits of normal (ULN)*

    • Renal impairment with creatinine clearance <30 ml/min*

    • Deemed to be at high risk of bleeding (e.g., recent bleeding, platelet count<100x109/L or hemoglobin <100g/L)*

    • Anticoagulant or NSAID therapy within the last 5 days

    • Antiplatelet agent other than aspirin and clopidogrel within the last 10 days

    • Uncontrolled hypertension (>=180/110mmHg)

    • within 3 months of planned randomization

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Population Health Research Institute, Hamilton General Hospital Hamilton Ontario Canada L8L 2X2

    Sponsors and Collaborators

    • Population Health Research Institute

    Investigators

    • Principal Investigator: Yan Liang, MD, Population Health Research Institute
    • Study Director: John Eikelboom, MD, Population Health Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    John Eikelboom, Dr, Population Health Research Institute
    ClinicalTrials.gov Identifier:
    NCT01341964
    Other Study ID Numbers:
    • 11-090
    First Posted:
    Apr 26, 2011
    Last Update Posted:
    Apr 28, 2015
    Last Verified:
    Apr 1, 2015
    Keywords provided by John Eikelboom, Dr, Population Health Research Institute
    Clopidogrel
    Aspirin
    Interaction
    Additional relevant MeSH terms:
    Aspirin
    Clopidogrel

    Study Results

    No Results Posted as of Apr 28, 2015