European Atrial Fibrillation Trial "EAFT"

Completed

Phase N/A Results

Trial Description

To study the value of anticoagulation in the secondary prevention of stroke in patients with non-rheumatic atrial fibrillation.

Interventions

  • Aspirin (stroke prevention) Drug
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
  • Warfarin (Coumadin┬«)Drug
    Other Names: Coumadin; Acenocoumarol
    Intervention Desc: Anticoagulant (Vitamin K antagonist)

Trial Design

Randomized, placebo-controlled, international trial of 455 patients at 108 centers.

Patient Involvement

Patients eligible for anticoagulation were randomized to receive either open-label oral anticoagulants or double-blind treatment with aspirin or placebo. Patients ineligible for anticoagulation, based on unwillingness of physician or patient, were randomized to receive either double-blind treatment with aspirin (300mg) or matching placebo. Physicians were allowed to choose the type of oral anticoagulant but treatment was adjusted to International Normalized Ratios (INR) or 2.5-4.0.

Outcomes

Type Measure Time Frame Safety Issue
Primary Vascular death, nonfatal stroke, nonfatal myocardial infarction or systemic embolism assessed every 4 months.
Secondary Death from all causes, non-fatal or fatal stroke of any cause, major thromboembolic events.

Sponsors

Netherlands Heart Foundation, Bayer Germany and Bayer subsidiaries in participating countries, UK Stroke Association, University Hospitals of Utrecht and Rotterdam.