Stroke Prevention in Reversible Ischemia Trial "SPIRIT"

Completed

Phase 3 Results

Trial Description

To compare the safety and efficacy of aspirin and oral anticoagulation.

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, open-label, controlled, clinical trial involving 1316 patients at 58 centers.

Patient Involvement

Patients were randomized to receive open treatment of aspirin (30 mg) or warfarin (INR 3.0 - 4.5).

Outcomes

Type Measure Time Frame Safety Issue
Primary Death from all vascular causes, or stroke, MI, or bleeding complication as measured every 6 months by clinic visit or telephone.
Secondary Death from all causes, death from vascular causes, and death from vascular causes or nonfatal stroke.