Clopidogrel and Aspirin Interaction Study-2 (Interaction2)

Population Health Research Institute (PHRI)

Status and phase: Completed; Phase 4

Conditions: Drug Action Increased

Treatments: Drug: Aspirin; Drug: Clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT01341964

11-090

Details and patient eligibility

About

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.

Full 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.

Enrollment: 302 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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302 participants in 2 patient groups

Higher dose aspirin group

Experimental group

Description:

Clopidogrel 600 mg plus aspirin 325mg

Treatment:

Drug: Aspirin

Drug: Clopidogrel

Drug: Aspirin

Low dose aspirin group

Active Comparator group

Description:

Clopidogrel 600mg plus aspirin 81mg

Treatment:

Drug: Aspirin

Drug: Clopidogrel

Drug: Aspirin