Clopidogrel/Aspirin Interaction Study (INTERACTION)

April 27, 2015 updated by: John Eikelboom, Population Health Research Institute

Randomized, Factorial Study to Explore Interaction Between Aspirin and Clopidogrel in Stable Patients With Previous Myocardial Infarction or Coronary Artery Stent

This study will explore the effect of different doses of aspirin on the effects of double-dose or standard dose clopidogrel.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Population Health Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard dose clopidogrel
300 mg Loading x 1 day, 75 mg/d x 13 days
Drug: Clopidogrel
300 mg loading dose, then 75 mg daily
Other Names:
  • Plavix
Drug: Clopidogrel
600 mg loading dose, 150 mg daily day 2-7, then 75 mg daily
Other Names:
  • Plavix
Experimental: Double dose clopidogrel
600 mg Loading x 1 day, 150 mg/d x 6 days, 75 mg/d x 7 days
Drug: Clopidogrel
300 mg loading dose, then 75 mg daily
Other Names:
  • Plavix
Drug: Clopidogrel
600 mg loading dose, 150 mg daily day 2-7, then 75 mg daily
Other Names:
  • Plavix
Active Comparator: Standard dose aspirin
Aspirin 81mg/d x 14 days
Drug: Aspirin
81 mg daily
Other Names:
  • Entrophen
Drug: Aspirin
325 mg daily
Other Names:
  • Novasen
Experimental: High dose aspirin
Aspirin 325 mg/d x 14 days
Drug: Aspirin
81 mg daily
Other Names:
  • Entrophen
Drug: Aspirin
325 mg daily
Other Names:
  • Novasen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood concentrations of the active metabolite of clopidogrel
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Inhibition of adenosine diphosphate (ADP) induced platelet aggregation
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Population Health Research Institute

Investigators

  • Study Director: John Eikelboom, MD., Population Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

April 8, 2010

First Submitted That Met QC Criteria

April 12, 2010

First Posted (Estimate)

April 13, 2010

Study Record Updates

Last Update Posted (Estimate)

April 28, 2015

Last Update Submitted That Met QC Criteria

April 27, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-082

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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