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Trial NCT00000517

Resource URI: http://static.linkedct.org/resource/trials/NCT00000517
linkedct:brief_title Boston Area Anticoagulation Trial for Atrial Fibrillation (BAATAF)
linkedct:condition <http://static.linkedct.org/resource/condition/1156>
linkedct:condition <http://static.linkedct.org/resource/condition/12992>
linkedct:condition <http://static.linkedct.org/resource/condition/1306>
linkedct:condition <http://static.linkedct.org/resource/condition/2312>
linkedct:condition <http://static.linkedct.org/resource/condition/2448>
linkedct:condition <http://static.linkedct.org/resource/condition/2470>
linkedct:condition <http://static.linkedct.org/resource/condition/2475>
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
linkedct:criteria Men and women, 18 years of age or older, with non-rheumatic atrial fibrillation.
linkedct:description 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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 18 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000517
rdfs:label Trial NCT00000517
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000517
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 36
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000517>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/20054>
linkedct:reference <http://static.linkedct.org/resource/reference/37352>
linkedct:reference <http://static.linkedct.org/resource/reference/38564>
linkedct:reference <http://static.linkedct.org/resource/reference/48535>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date July 1985
linkedct:study_design Prevention, Randomized
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date May 2000