Clopidogrel/Aspirin Interaction Study

NCT01102439 | Completed Phase 4

• 1 other identifier: 10-082
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Artery Disease

Keywords

Clopidogrel; Aspirin; Interaction

Outcome Measures

Primary Outcomes (1)

• Blood concentrations of the active metabolite of clopidogrel

  14 days

Secondary Outcomes (1)

• Inhibition of adenosine diphosphate (ADP) induced platelet aggregation

  14 days

Study Arms (4)

Standard dose clopidogrel

ACTIVE COMPARATOR

300 mg Loading x 1 day, 75 mg/d x 13 days

Drug: Clopidogrel

Double dose clopidogrel

EXPERIMENTAL

600 mg Loading x 1 day, 150 mg/d x 6 days, 75 mg/d x 7 days

Drug: Clopidogrel

Standard dose aspirin

ACTIVE COMPARATOR

Aspirin 81mg/d x 14 days

Drug: Aspirin

High dose aspirin

EXPERIMENTAL

Aspirin 325 mg/d x 14 days

Drug: Aspirin

Interventions

Clopidogrel DRUG

300 mg loading dose, then 75 mg daily

Also known as: Plavix

Standard dose clopidogrel

Aspirin DRUG

81 mg daily

Also known as: Entrophen

Standard dose aspirin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Population Health Research Institute: lead

Study Sites (1)

Population Health Research Institute

Hamilton, Ontario, L8L 2X2, Canada

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Clopidogrel; Aspirin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Yan Liang, MD

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

• John Eikelboom, MD.

  Population Health Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD.

Study Record Dates

• First Submitted: April 8, 2010
• First Posted: April 13, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: February 1, 2013
• Last Updated: April 28, 2015

Record last verified: 2015-04

Locations

CA (1)