Trial record 2 of 1176 for:    "Embolism and Thrombosis"

Boston Area Anticoagulation Trial for Atrial Fibrillation (BAATAF)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
J. Philip Kistler, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00000517
First received: October 27, 1999
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Arrhythmia
Atrial Fibrillation
Cardiovascular Diseases
Cerebral Embolism and Thrombosis
Cerebrovascular Disorders
Heart Diseases
Thrombophlebitis
Cerebrovascular Accident
Drug: warfarin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Study Start Date: July 1985
Study Completion Date: June 1991
Primary Completion Date: June 1991 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: J. Philip Kistler, Physician, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00000517     History of Changes
Other Study ID Numbers: 36, R01HL033233-06
Study First Received: October 27, 1999
Last Updated: April 9, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Embolism and Thrombosis
Intracranial Embolism and Thrombosis
Arrhythmias, Cardiac
Atrial Fibrillation
Cardiovascular Diseases
Intracranial Embolism
Cerebrovascular Disorders
Embolism
Heart Diseases
Cerebral Infarction
Stroke
Thrombophlebitis
Thrombosis
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Thromboembolism
Brain Infarction
Brain Ischemia
Venous Thrombosis
Phlebitis
Peripheral Vascular Diseases
Vasculitis
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014