Skip to main content
OpenTrials
Completed

NCT Number: NCT01341964

Clopidogrel and Aspirin Interaction Study-2

Clopidogrel and aspirin are commonly used in combination to prevent heart attacks and to prevent blockage of stents. Both clopidogrel and aspirin work by preventing platelets (sticky cells that circulate in the blood) from forming blood clots in the arteries supplying oxygen to the heart and in stents. The investigators hypothesize that aspirin 325mg compared with aspirin 81 mg will increase blood levels of the active metabolite of clopidogrel in patients with a history of coronary artery disease who receive a 600mg loading dose of clopidogrel.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Drug Action Increased

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Population Health Research Institute, Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

About this study

Eligible patients will be randomized to receive clopidogrel 600mg + aspirin 325mg (Group A) or clopidogrel 600mg + aspirin 81mg (Group B). Patients will be fasted for at least 8 hours prior to study drug administration. Blood samples will be collected at 1 hour after study drug administration for measurement of clopidogrel active metabolite levels and genotyping.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Stable patients >1 month post ACS (including ST elevated myocardial infarction, non-ST elevated myocardial infarction or unstable angina) or stent
  • Receiving regular ASA (81mg/d) and clopidogrel (75mg/d) for at least 1 week
  • Written informed consent

Exclusion criteria

  • Age < 18 years
  • Liver disease with ALT or bilirubin >2x upper limits of normal (ULN)*
  • Renal impairment with creatinine clearance <30 ml/min*
  • Deemed to be at high risk of bleeding (e.g., recent bleeding, platelet count<100x109/L or hemoglobin <100g/L)*
  • Anticoagulant or NSAID therapy within the last 5 days
  • Antiplatelet agent other than aspirin and clopidogrel within the last 10 days
  • Uncontrolled hypertension (>=180/110mmHg)
  • within 3 months of planned randomization

Treatment and study plan

clopidogrel

Drug

600mg (2 pills)

Other names: Plavix

Aspirin

Drug

325mg (1 pill)

Other names: Novasen

Primary outcomes

  1. Blood Concentration of the Active Metabolite of Clopidogrel

    Time frame: 1 hour after loading dose of study medications

    Clopidogrel active metabolite concentration will be measured by liquid chromatography tandem mass spectrometry (LC/MS) methods.

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Official study title

Randomized Controlled Trial to Explore Interaction Between Aspirin and Clopidogrel in Stable Patients With Previous Myocardial Infarction or Coronary Artery Stent

Acronym: Interaction2

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 26, 2011
Registry last updated
Jul 27, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.