Primary Prevention of Arterial Thromboembolism in Nonrheumatic Atrial Fibrillation "PATAF"

Completed

Phase 3 Results

Trial Description

To compare the preventive efficacy of low-intensity anticoagulation (AC), and regular-intensity AC therapies with that of aspirin for the occurrence of thromboembolism in non-rheumatic atrial fibrillation (AF) patients.

Interventions

  • Warfarin (Coumadin┬«)Drug
    Other Names: Coumadin; Acenocoumarol
    Intervention Desc: Anticoagulant (Vitamin K antagonist)

Trial Design

Randomized, primary-care based trial of 729 patients at 15 centers.

Patient Involvement

Patients eligible for regular-intensity AC were randomly assigned to aspirin at 150 mg/d, low-intensity AC, or regular AC in group I. In cases of noneligibility for regular AC, the trial randomized patients between aspirin and low-intensity AC (assigned to group II). Patients were followed by general practitioner every four months until the end of the study or earlier death.

Outcomes

Type Measure Time Frame Safety Issue
Primary Stroke (including intracranial hemorrhage), systemic embolism, major hemorrhage, or vascular death.
Secondary Nonfatal myocardial infarction (ECG registration and laboratory findings), retinal infarct, TIA, minor bleeding complication, and death by non-vascular cause.