Comparison of Efficacy and Safety Between Aspirin and Clopidogrel in the Atrial Fibrillation With Low or Moderate Stroke Risk
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 1,500
- Primary Endpoint
- Major Cerebrovascular and cardiac events including stroke, CV death, MI
Study Overview
Brief Summary
This study was designed in order to evaluate and compare the efficacy and safety between aspirin and clopidogrel in the patient with low stroke risk Atrial Fibrillation (AF).
Detailed Description
Efficacy outcome will be evaluated the major cerebro-cardiovascular event including stroke, cardiovascular death, and myocardial infarction during 1 year-medication period. In addition, safety outcome will be evaluated the gastrointestinal responses including peptic ulcer and upper gastrointestinal bleeding events to both study drugs by repeated gastroenteroscopic examinations before and after medication by GI specialist.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Man or Women > 20 years old
- •newly detected AF (CHA2DS2VASc index score: 1)
- •Patient who needs antiplatelet therapy using aspirin clopidogrel for stroke prevention
- •volunteer only
- •childbearing aged women who takes proper oral contraceptive
Exclusion Criteria
- •No specific contraindication or any history of hypersensitivity of Clopidogrel or aspirin
- •Patient with active GI bleeding or bleeding tendency or major bleeding history
- •less than 1 year of residual expected life
- •Pregnant or breast-feeding women
- •Other causes, determined by charged physician
- •Patient with definite GERD who needs special treatment
- •Patient who needs to take NSAID (Non-Steroidal Anti-Inflammatory Drug) for more than 2 weeks
Arms & Interventions
Intervention: Clopidogrel
Case management with clopidogrel 75mg once daily is provided for stroke prevention in AF patient.
Intervention: Clopidogrel (Drug)
Control: Aspirin
Usual care with aspirin 100mg once daily is provided for stroke prevention in AF patient.
Intervention: Aspirin (Drug)
Outcomes
Primary Outcomes
Major Cerebrovascular and cardiac events including stroke, CV death, MI
Time Frame: 1 year after randomization
Number of each event
Major gastrointestinal event including peptic ulcer disease and bleeding
Time Frame: 1 year after randomization
Number of each event
Secondary Outcomes
No secondary outcomes reported
Investigators
Sang Min Park
Professor
Chuncheon Sacred Heart Hospital