Cardiovascular Diseases Clinical Trial
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.
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 June 1989. The
experimental group of 212 patients received long-term, low-dose warfarin. The control group
of 208 patients did not receive warfarin but could choose to take aspirin. Average follow-up
was 2.2 years. The primary endpoint was non-hemorrhage stroke. At entry and annually, the
history was recorded and patients underwent a physical examination focusing on neurologic
factors. Every year, beginning at six months, patients were sent a questionnaire on
neurologic symptoms, bleeding episodes, and other medical conditions. Study nurses contacted
all patients to review their responses. Each patient's referring physician was contacted at
three months and nine months during each year of follow-up.
Participating institutions in the multicenter trial were organized into three groups. At
Group I institutions, on-site investigators performed all clinical evaluations. In Group II,
personnel from the central site hospital, the Massachusetts General Hospital, traveled to
the local hospitals to evaluate, randomize, and follow patients. Group III institutions
referred patients directly to the Massachusetts General Hospital for all procedures.
;
Allocation: Randomized, Primary Purpose: Prevention
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