Clopidogrel/Aspirin Interaction Study

Coronary Artery Disease Clinical Trial

— INTERACTION  

Official title:

Randomized, Factorial Study 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: NCT01102439
• Other study ID #: 10-082
• Status: Completed
• Phase: Phase 4
• First received: April 8, 2010
• Last updated: April 27, 2015
• Start date: April 2010
• Est. completion date: February 2013

Study information

• Verified date: April 2015
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: February 2013
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Clopidogrel
300 mg loading dose, then 75 mg daily
• Clopidogrel
600 mg loading dose, 150 mg daily day 2-7, then 75 mg daily
• Aspirin
81 mg daily
• Aspirin
325 mg daily

Locations

Country	Name	City	State
Canada	Population Health Research Institute	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 concentrations of the active metabolite of clopidogrel		14 days	No
Secondary	Inhibition of adenosine diphosphate (ADP) induced platelet aggregation		14 days	No