A randomised controlled trial of warfarin vs aspirin for atrial fibrillation in an elderly (aged 75 and over) primary care population: Birmingham Atrial Fibrillation Treatment of the Aged study

Phase 4

Completed

• Conditions: Atrial fibrillation in primary care; Circulatory System; Atrial fibrillation

• Registration Number: ISRCTN89345269
• Lead Sponsor: niversity of Birmingham (UK)

Brief Summary

2003 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/12939169 2007 main results in: http://www.ncbi.nlm.nih.gov/pubmed/17693178 2007 secondary analysis in: http://www.ncbi.nlm.nih.gov/pubmed/16887213 2010 recruitment analysis in: http://www.ncbi.nlm.nih.gov/pubmed/20610490 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24692475

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2000-10-23
• Last Update Posted: 30 April 2018
• Study Completion: 2019-06-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 973

Inclusion Criteria

1. Age 75 or over
2. Non-rheumatic atrial fibrillation confirmed by electrocardiogram (ECG)

Exclusion Criteria

1. Already on warfarin
2. History of major haemorrhage
3. Recent peptic ulcer disease (previous year)
4. Sensitivity to any of the study medications
5. Rheumatic heart disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fatal or non-fatal disabling stroke (ischaemic or haemorrhagic) or significant systemic embolism

Secondary Outcome Measures

Name	Time	Method
1. Hospitalisation or death as a result of non-intracranial haemorrhage<br>2. Death (all cause)<br>3. Admission to hospital (all cause)<br>4. Quality of life (SF-12 & Euroqol 5D)<br>5. Disability (Rankin score)