Clopidogrel and Aspirin Interaction Study-2

Drug Action Increased Clinical Trial

— Interaction2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01341964
• Other study ID #: 11-090
• Status: Completed
• Phase: Phase 4
• Start date: May 2011
• Est. completion date: April 2013

Study information

• Verified date: September 2022
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Action Increased

Intervention

Drug:
• Clopidogrel
600mg (2 pills)
• Aspirin
325mg (1 pill)
• Aspirin
81mg (1 pill)

Locations

Country	Name	City	State
Canada	Population Health Research Institute, Hamilton General Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Population Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Concentration of the Active Metabolite of Clopidogrel	Clopidogrel active metabolite concentration will be measured by liquid chromatography tandem mass spectrometry (LC/MS) methods.	1 hour after loading dose of study medications