NCT00000517

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jul 1985

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1985

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 1991

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 1991

Completed
8.4 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

April 10, 2014

Status Verified

April 1, 2014

Enrollment Period

5.9 years

First QC Date

October 27, 1999

Last Update Submit

April 9, 2014

Conditions

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Men and women, 18 years of age or older, with non-rheumatic atrial fibrillation.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (4)

  • Boston Area Anticoagulation Trial for Atrial Fibrillation Investigators; Singer DE, Hughes RA, Gress DR, Sheehan MA, Oertel LB, Maraventano SW, Blewett DR, Rosner B, Kistler JP. The effect of low-dose warfarin on the risk of stroke in patients with nonrheumatic atrial fibrillation. N Engl J Med. 1990 Nov 29;323(22):1505-11. doi: 10.1056/NEJM199011293232201.

    PMID: 2233931BACKGROUND
  • Lancaster TR, Singer DE, Sheehan MA, Oertel LB, Maraventano SW, Hughes RA, Kistler JP. The impact of long-term warfarin therapy on quality of life. Evidence from a randomized trial. Boston Area Anticoagulation Trial for Atrial Fibrillation Investigators. Arch Intern Med. 1991 Oct;151(10):1944-9.

    PMID: 1929681BACKGROUND
  • Singer DE, Hughes RA, Gress DR, Sheehan MA, Oertel LB, Maraventano SW, Blewett DR, Rosner B, Kistler JP. The effect of aspirin on the risk of stroke in patients with nonrheumatic atrial fibrillation: The BAATAF Study. Am Heart J. 1992 Dec;124(6):1567-73. doi: 10.1016/0002-8703(92)90074-6.

    PMID: 1462916BACKGROUND
  • Kistler JP, Singer DE, Millenson MM, Bauer KA, Gress DR, Barzegar S, Hughes RA, Sheehan MA, Maraventano SW, Oertel LB, et al. Effect of low-intensity warfarin anticoagulation on level of activity of the hemostatic system in patients with atrial fibrillation. BAATAF Investigators. Stroke. 1993 Sep;24(9):1360-5. doi: 10.1161/01.str.24.9.1360.

    PMID: 8362431BACKGROUND

MeSH Terms

Conditions

Arrhythmias, CardiacAtrial FibrillationCardiovascular DiseasesIntracranial Embolism and ThrombosisCerebrovascular DisordersHeart DiseasesThrombophlebitisStroke

Interventions

Warfarin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesThromboembolismEmbolism and ThrombosisVenous ThrombosisThrombosisPhlebitisPeripheral Vascular DiseasesVasculitis

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
PREVENTION
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

July 1, 1985

Primary Completion

June 1, 1991

Study Completion

June 1, 1991

Last Updated

April 10, 2014

Record last verified: 2014-04