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Completed

NCT Number: NCT01102439

Clopidogrel/Aspirin Interaction Study

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Population Health Research Institute

Hamilton, Ontario, L8L 2X2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clopidogrel

Drug

300 mg loading dose, then 75 mg daily

Other names: Plavix

Aspirin

Drug

81 mg daily

Other names: Entrophen

Primary outcomes

  1. Blood concentrations of the active metabolite of clopidogrel

    Time frame: 14 days

Secondary outcomes

  1. Inhibition of adenosine diphosphate (ADP) induced platelet aggregation

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Official study title

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

Acronym: INTERACTION

Important dates

Study start
2010
Primary completion
2010
Study completion
2013
First posted
Apr 13, 2010
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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