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Clopidogrel/Aspirin Interaction Study

Information source: Population Health Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Artery Disease

Intervention: Clopidogrel (Drug); Clopidogrel (Drug); Aspirin (Drug); Aspirin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Population Health Research Institute

Official(s) and/or principal investigator(s):
Yan Liang, MD, Principal Investigator, Affiliation: Population Health Research Institute
John Eikelboom, MD., Study Director, Affiliation: Population Health Research Institute

Summary

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

Clinical Details

Official title: Randomized, Factorial Study to Explore Interaction Between Aspirin and Clopidogrel in Stable Patients With Previous Myocardial Infarction or Coronary Artery Stent

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

Primary outcome: Blood concentrations of the active metabolite of clopidogrel

Secondary outcome: Inhibition of adenosine diphosphate (ADP) induced platelet aggregation

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Population Health Research Institute, Hamilton, Ontario L8L 2X2, Canada
Additional Information

Starting date: April 2010
Last updated: April 27, 2015

Page last updated: August 23, 2015

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