Clopidogrel/Aspirin Interaction Study (INTERACTION)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Clopidogrel
Clopidogrel
Aspirin
Aspirin
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Clopidogrel, Aspirin, Interaction
Eligibility 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
Sites / Locations
- Population Health Research Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Active Comparator
Experimental
Arm Label
Standard dose clopidogrel
Double dose clopidogrel
Standard dose aspirin
High dose aspirin
Arm Description
300 mg Loading x 1 day, 75 mg/d x 13 days
600 mg Loading x 1 day, 150 mg/d x 6 days, 75 mg/d x 7 days
Aspirin 81mg/d x 14 days
Aspirin 325 mg/d x 14 days
Outcomes
Primary Outcome Measures
Blood concentrations of the active metabolite of clopidogrel
Secondary Outcome Measures
Inhibition of adenosine diphosphate (ADP) induced platelet aggregation
Full Information
NCT ID
NCT01102439
First Posted
April 8, 2010
Last Updated
April 27, 2015
Sponsor
Population Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01102439
Brief Title
Clopidogrel/Aspirin Interaction Study
Acronym
INTERACTION
Official Title
Randomized, Factorial Study to Explore Interaction Between Aspirin and Clopidogrel in Stable Patients With Previous Myocardial Infarction or Coronary Artery Stent
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Population Health Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will explore the effect of different doses of aspirin on the effects of double-dose or standard dose clopidogrel.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Clopidogrel, Aspirin, Interaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard dose clopidogrel
Arm Type
Active Comparator
Arm Description
300 mg Loading x 1 day, 75 mg/d x 13 days
Arm Title
Double dose clopidogrel
Arm Type
Experimental
Arm Description
600 mg Loading x 1 day, 150 mg/d x 6 days, 75 mg/d x 7 days
Arm Title
Standard dose aspirin
Arm Type
Active Comparator
Arm Description
Aspirin 81mg/d x 14 days
Arm Title
High dose aspirin
Arm Type
Experimental
Arm Description
Aspirin 325 mg/d x 14 days
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
Plavix
Intervention Description
300 mg loading dose, then 75 mg daily
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
Plavix
Intervention Description
600 mg loading dose, 150 mg daily day 2-7, then 75 mg daily
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
Entrophen
Intervention Description
81 mg daily
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
Novasen
Intervention Description
325 mg daily
Primary Outcome Measure Information:
Title
Blood concentrations of the active metabolite of clopidogrel
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Inhibition of adenosine diphosphate (ADP) induced platelet aggregation
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Liang, MD
Organizational Affiliation
Population Health Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Eikelboom, MD.
Organizational Affiliation
Population Health Research Institute
Official's Role
Study Director
Facility Information:
Facility Name
Population Health Research Institute
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
12. IPD Sharing Statement
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Clopidogrel/Aspirin Interaction Study
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