Efficacy and Safety of Aspirin and Clopidogrel in the Atrial Fibrillation With Low or Moderate Stroke Risk "CESAC-AF"

Not yet recruiting

Phase 3 Results N/A

Trial Description

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.

Conditions

Interventions

  • Clopidogrel (Plavix┬«)Drug
    Other Names: Plavix
    ARM 1: Kind: Experimental
    Label: Intervention: Clopidogrel
    Description: Case management with clopidogrel 75mg once daily is provided for stroke prevention in AF patient.
  • Aspirin Drug
    Other Names: Aspirin at bedtime
    ARM 1: Kind: Experimental
    Label: Control: Aspirin
    Description: Usual care with aspirin 100mg once daily is provided for stroke prevention in AF patient.

Outcomes

Type Measure Time Frame Safety Issue
Primary Major Cerebrovascular and cardiac events including stroke, CV death, MI 1 year after randomization
Primary Major gastrointestinal event including peptic ulcer disease and bleeding 1 year after randomization

Sponsors