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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
Population Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Clopidogrel, Aspirin, Interaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 8, 2010
Last Updated
April 27, 2015
Sponsor
Population Health Research Institute
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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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