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Clopidogrel/Aspirin Interaction Study (INTERACTION)

This study has been completed.
Sponsor:
Information provided by:
Population Health Research Institute
ClinicalTrials.gov Identifier:
NCT01102439
First received: April 8, 2010
Last updated: March 23, 2011
Last verified: February 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Coronary Artery Disease
 Drug: Clopidogrel
Drug: Aspirin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Factorial Study to Explore Interaction Between Aspirin and Clopidogrel in Stable Patients With Previous Myocardial Infarction or Coronary Artery Stent

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Population Health Research Institute:

Primary Outcome Measures:
  • Blood concentrations of the active metabolite of clopidogrel [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inhibition of adenosine diphosphate (ADP) induced platelet aggregation [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: April 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard dose clopidogrel Drug: Clopidogrel
300 mg loading dose, then 75 mg daily
Other Name: Plavix
Experimental: Double dose clopidogrel Drug: Clopidogrel
600 mg loading dose, 150 mg daily day 2-7, then 75 mg daily
Other Name: Plavix
Active Comparator: Standard dose aspirin Drug: Aspirin
81 mg daily
Other Name: Entrophen
Experimental: High dose aspirin Drug: Aspirin
325 mg daily
Other Name: Novasen

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 ASA 325 mg/d as compared to ASA 81 mg/d.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > 1 month post 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01102439

Locations
Canada, Ontario
Population Health Research Institute
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
Population Health Research Institute
Investigators
Principal Investigator: Yan Liang, MD Population Health Research Institute
  More Information

No publications provided

Responsible Party: Dr. Yan Liang, Population Health Research Institute
ClinicalTrials.gov Identifier: NCT01102439     History of Changes
Other Study ID Numbers: 10-082
Study First Received: April 8, 2010
Last Updated: March 23, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Population Health Research Institute:
Clopidogrel
Aspirin
Interaction

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Ticlopidine
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013