NCT01341964

Clopidogrel and Aspirin Interaction Study-2

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 302 (actual)
• Sponsor: Population Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Drug Action Increased

Interventions

Type	Name	Description
DRUG	Clopidogrel	600mg (2 pills)
DRUG	Aspirin	325mg (1 pill)
DRUG	Aspirin	81mg (1 pill)

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2011-04-26
• Last updated: 2023-07-27
• Results posted: 2023-07-27

Locations

1 site across 1 country: Canada