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Clopidogrel and Aspirin Interaction Study-2 (Interaction2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yan Liang, Population Health Research Institute
ClinicalTrials.gov Identifier:
NCT01341964
First received: April 25, 2011
Last updated: May 15, 2013
Last verified: May 2013

April 25, 2011
May 15, 2013
May 2011
April 2013   (final data collection date for primary outcome measure)
Blood concentration of the active metabolite of clopidogrel [ Time Frame: 1 hour after loading dose of study medications ] [ Designated as safety issue: No ]
Clopidogrel active metabolite concentration will be measured by liquid chromatography tandem mass spectrometry (LC/MS) methods.
Same as current
Complete list of historical versions of study NCT01341964 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Clopidogrel and Aspirin Interaction Study-2
Randomized Controlled Trial to Explore Interaction Between Aspirin and Clopidogrel in Stable Patients With Previous Myocardial Infarction or Coronary Artery Stent

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Drug Action Increased
  • Drug: Clopidogrel
    600mg (2 pills)
    Other Name: Plavix
  • Drug: Aspirin
    325mg (1 pill)
    Other Name: Novasen
  • Drug: Aspirin
    81mg (1 pill)
    Other Name: Entrophen
  • Experimental: Higher dose aspirin group
    Clopidogrel 600 mg plus aspirin 325mg
    Interventions:
    • Drug: Clopidogrel
    • Drug: Aspirin
  • Active Comparator: Low dose aspirin group
    Clopidogrel 600mg plus aspirin 81mg
    Interventions:
    • Drug: Clopidogrel
    • Drug: Aspirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01341964
11-090
No
Yan Liang, Population Health Research Institute
Yan Liang
Not Provided
Principal Investigator: Yan Liang, MD Population Health Research Institute
Study Director: John Eikelboom, MD Population Health Research Institute
Population Health Research Institute
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP