It is widely recognized that atrial fibrillation (AF) predisposes patients to embolic stroke and systemic emboli. Although oral anticoagulant therapy has been suggested to decrease the incidence of embolic events, its benefits have not been proven and its attendent risks of hemorrhage prevent its application without confirmed benefits. The purpose of this study is to evaluate the benefits and risks of oral anticoagulant therapy in reducing embolic stroke and systemic emboli in patients with AF, without rheumatic heart disease. The benefits and risks of anticoagulation will be evaluated by a randomized, controlled trial assigning patients to treatment (anticoagulation) and no treatment groups. If treatment is beneficial, the annual incidence of embolic events should decrease from 5% in the control group to less than 1% in the treatment group. The incidence of hemorrhagic complications of the treatment and control groups will be quantitated to evaluate the risks of therapy.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project (R01)
Project #
5R01HL033233-02
Application #
3344868
Study Section
Clinical Trials Review Committee (CLTR)
Project Start
1985-07-01
Project End
1990-06-30
Budget Start
1986-07-01
Budget End
1987-06-30
Support Year
2
Fiscal Year
1986
Total Cost
Indirect Cost
Name
Massachusetts General Hospital
Department
Type
DUNS #
City
Boston
State
MA
Country
United States
Zip Code
02199