National Study for Prevention of Embolism in Atrial Fibrillation "NASPEAF"

Completed

Phase N/A Results

Trial Description

To evaluate the efficacy and safety of the combination of antiplatelet and moderate-intensity anticoagulation therapy in patients with atrial fibrillation associated with recognized risk factors or mitral stenosis.

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

Prospective, multicenter, randomized open-label study.

Patient Involvement

Patients were divided in two groups: the high-risk group included nonvalvular plus prior embolism and patients with mitral stenosis with and with-out prior embolism and consisted of 495 patients (with a median follow-up 1,075 days); and the intermediate-risk group with 714 patients included patients with risk factors or over 60 years of age with a median follow-up 965 days. In the intermediate risk group 242 received the cyclooxygenase inhibitor triflusal, 237 received acenocumarol, and 235 received a combination of both. In the high risk group, 259 received anticoagulants and 236 received the combined therapy.

Outcomes

Type Measure Time Frame Safety Issue
Primary A composite of vascular mortality, transient ischemic attack (TIA), and nonfatal stroke or systemic embolism, whichever came first.
Secondary Severe bleeding, MI, nonvascular mortality, and non-severe bleeding. The composite of primary outcomes and severe bleeding was jointly analyzed to evaluate the benefit-to-risk ratio.

Sponsors

Spanish Society of Cardiology (Madrid) and Uriach Foundation (Barcelona).