Boston Area Anticoagulation Trial for Atrial Fibrillation (BAATAF)

April 9, 2014 updated by: J. Philip Kistler, Massachusetts General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Men and women, 18 years of age or older, with non-rheumatic atrial fibrillation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1985

Primary Completion (Actual)

June 1, 1991

Study Completion (Actual)

June 1, 1991

Study Registration Dates

First Submitted

October 27, 1999

First Submitted That Met QC Criteria

October 27, 1999

First Posted (Estimate)

October 28, 1999

Study Record Updates

Last Update Posted (Estimate)

April 10, 2014

Last Update Submitted That Met QC Criteria

April 9, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36
  • R01HL033233-06 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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