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Boston Area Anticoagulation Trial for Atrial Fibrillation (BAATAF)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000517
First Posted: October 28, 1999
Last Update Posted: April 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
J. Philip Kistler, Massachusetts General Hospital
October 27, 1999
October 28, 1999
April 10, 2014
July 1985
June 1991   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00000517 on ClinicalTrials.gov Archive Site
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Boston Area Anticoagulation Trial for Atrial Fibrillation (BAATAF)
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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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Prevention
  • Arrhythmia
  • Atrial Fibrillation
  • Cardiovascular Diseases
  • Cerebral Embolism and Thrombosis
  • Cerebrovascular Disorders
  • Heart Diseases
  • Thrombophlebitis
  • Cerebrovascular Accident
Drug: warfarin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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June 1991
June 1991   (Final data collection date for primary outcome measure)
Men and women, 18 years of age or older, with non-rheumatic atrial fibrillation.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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NCT00000517
36
R01HL033233-06 ( U.S. NIH Grant/Contract )
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J. Philip Kistler, Massachusetts General Hospital
Massachusetts General Hospital
National Heart, Lung, and Blood Institute (NHLBI)
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Massachusetts General Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP