Stroke Prevention in Atrial Fibrillation III "SPAF III"

Completed

Phase N/A Results

Trial Description

To compare low-intensity, fixed-dose warfarin plus aspirin with conventional adjusted-dose warfarin in patients with atrial fibrillation (AF) at high risk of stroke.

Interventions

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

Trial Design

Randomized, clinical trial of 1044 patients at 20 centers in USA and Canada.

Patient Involvement

Patients were randomized to receive either low-intensity fixed-dose warfarin (INR 1.2-1.5 for initial dose adjustment) and aspirin (325 mg/day) or adjusted-dose warfarin (INR 2.0-3.0).

Outcomes

Type Measure Time Frame Safety Issue
Primary Ischemic stroke and systemic embolism as measured during monthly telephone interview, clinic follow-up every 3 months, and yearly standard symptom questionnaire..
Secondary Transient ischemic attack, intracranial hemorrhage, disabling or fatal stroke.

Sponsors

National Institute for Neurological Disorders and Stroke, NIH