Stroke Trials Registry

EAFT
European Atrial Fibrillation Trial

Principal Investigator
Dr. Peter J. Koudstaal

PI Address
Department of Neurology, University Hospital Rotterdam, Rotterdam, Netherlands.

Contact Address
Dr. Peter J. Koudstaal, Department of Neurology, University Hospital Rotterdam, Dr Molewaterplein 40, 3015 GD Rotterdam, Netherlands.

Sponsor

Study Size Actual:	1007
Max Time from onset:	3 Months
Min Age:	25

Status:
Trial complete. Results published 11/93.

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

Interventions:

Aspirin (stroke prevention)
Antiplatelet agent; inhibits thromboxane A2

Warfarin
Anticoagulant (Vitamin K antagonist)

Location(s):
12 European countries and Israel

Year Published: 1993

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

Inclusion Criteria
Over 25 years of age, nonrheumatic atrial fibrillation and TIA or minor ischemic stroke within 3 months of entry.

Exclusion Criteria
Atrial fibrillation secondary to another disorder; contraindication or indication for aspirin; already taking non-steroid anti-inflammatory drugs, other anti-platelet-aggregating drugs, or oral anticoagulants; other sources of cardiac emboli, planned carotid endarterectomy or coronary surgery within next 3 months.

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.

Primary Outcome:
Vascular death, nonfatal stroke, nonfatal myocardial infarction or systemic embolism assessed every 4 months.

Secondary Outcome:
Death from all causes, non-fatal or fatal stroke of any cause, major thromboembolic events.

Results:
The rate of primary outcomes was significantly reduced in patients receiving oral anticoagulation (8%) compared to those in control group (17% per year). The difference was even more pronounced in the reduction in risk of stroke alone. Oral anticoagulation was found to be more effective than aspirin in preventing the occurrence of a primary event (p=0.008). Results of aspirin vs. placebo arms of both groups were combined. Patients assigned to aspirin had a lower risk of a primary outcome event and of stroke alone but neither effects were statistically significant.

Source of Information:
Lancet 1993;342:1255-1262.

Web Links and Publications:

Major bleeding during anticoagulation after cerebral ischemia: patterns and risk factors. Stroke Prevention In Reversible Ischemia Trial (SPIRIT). European Atrial Fibrillation Trial (EAFT) study groups.
Neurology. 1999 Oct 12;53(6):1319-27.

The efficacy of aspirin in patients with atrial fibrillation. Analysis of pooled data from 3 randomized trials. The Atrial Fibrillation Investigators.
Arch Intern Med. 1997 Jun 9;157(11):1237-40.

Silent brain infarction in nonrheumatic atrial fibrillation. EAFT Study Group. European Atrial Fibrillation Trial.
Neurology. 1996 Jan;46(1):159-65.

Optimal oral anticoagulant therapy in patients with nonrheumatic atrial fibrillation and recent cerebral ischemia. The European Atrial Fibrillation Trial Study Group.
N Engl J Med 1995 Jul 6;333(1):5-10.

Comparison of CT in patients with cerebral ischaemia with or without non-rheumatic atrial fibrillation. European Atrial Fibrillation Trial and Dutch T I A Trial Study Groups.
J Neurol Neurosurg Psychiatry. 1995 Aug;59(2):132-7.

Predictors of major vascular events in patients with a transient ischemic attack or minor ischemic stroke and with nonrheumatic atrial fibrillation. European Atrial Fibrillation Trial (EAFT) Study Group.
Stroke 1995 May;26(5):801-6.

Secondary prevention in non-rheumatic atrial fibrillation after transient ischaemic attack or minor stroke. EAFT (European Atrial Fibrillation Trial) Study Group.
Lancet 1993 Nov 20;342(8882):1255-62.

This information last updated on: 11/14/2000

UID: 151