Clinical Trial: Boston Area Anticoagulation Trial for Atrial Fibrillation (BAATAF)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title:
Brief Summary: To determine the benefits and risks of oral anticoagulant therapy in reducing embolic stroke and systemic emboli in patients with atrial fibrillation without rheumatic heart disease.
Detailed Summary:
BACKGROUND:
The efficacy of oral anticoagulation therapy in reducing the risk of embolic stroke in patients with atrial fibrillation and rheumatic heart disease was well known. The value of anticoagulant therapy in patients with atrial fibrillation without rheumatic heart disease had not been established. Several studies strongly suggested that although the risk of stroke in patients with atrial fibrillation was greatest in the presence of valvular disease, the risk of stroke in the absence of valvular disease was also much greater in patients with atrial fibrillation than those without this arrhythmia. What was lacking was a detailed controlled study assessing the degree of reduction in stroke risk by anticoagulation of fibrillating patients without valvular disease.
The second question asked was whether the added potential morbidity or mortality associated with long-term anticoagulation therapy justified its use in the prophylactic treatment of neurologically asymptomatic patients with atrial fibrillation, even if it did reduce stroke risk. Gastrointestinal, urinary tract, cutaneous and joint hemorrhages were all potential serious complications, as was cerebral hemorrhage, including bleeding into areas of recent cerebral infarction. Interest had again focused on hemorrhagic complications of stroke in anticoagulated patients and among risk factors for hemorrhage were large, recent infarcts. No one suggested that anticoagulation, even if very successful in reducing stroke risk, would eliminate it altogether, and thus hemorrhagic infarction was an important potential problem, as was assessment of risk of primary intracerebral hemorrhage.
DESIGN NARRATIVE:
Randomized non-blind. Recruitment began in September 1985 and ended in
Sponsor: Massachusetts General Hospital
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Massachusetts General Hospital
Dates:
Date Received: October 27, 1999
Date Started: July 1985
Date Completion:
Last Updated: April 9, 2014
Last Verified: April 2014
