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ISRCTN
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ISRCTN89345269
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DOI
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10.1186/ISRCTN89345269
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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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
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Scientific title
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Acronym
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BAFTA
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Serial number at source
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G9900264
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Study hypothesis
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To address the question is warfarin better than aspirin in the treatment of patients aged 75 or over identified in general practice with atrial fibrillation? Specifically to test whether:
1. Adjusted dose warfarin (target INR 2.5) will lead to a significantly lower incidence of fatal or disabling stroke (ischaemic or haemorrhagic) or systemic embolus as compared to aspirin (75mg/day)?
2. There will be no significant difference in the incidence of major non-intracranial haemorrhage (a bleeding event requiring hospital admission or causing death) in the two groups?
3. There will be no significant difference in the death rate (all cause) or hospitalisation rate (all cause) in the two groups?
4. A secondary null hypothesis to be tested is that for the patients randomised to warfarin:
there will be no difference in the proportion of time spent within the target INR range between patients managed in general practice using near patient testing and computerised decision support software and patients managed by a traditional hospital anticoagulation clinic.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Atrial fibrillation in primary care
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Participants - inclusion criteria
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1. Age 75 or over
2. Non-rheumatic atrial fibrillation confirmed by electrocardiogram (ECG)
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Participants - exclusion criteria
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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
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Anticipated start date
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01/10/1999
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Anticipated end date
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31/12/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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973
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Interventions
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Patients will be randomised to:
1. Aspirin 75 mg daily
2. Warfarin, target international normalized ratio (INR) 2.5.
Follow-up:
1. Review of GP records at six monthly intervals
2. Annual patient questionnaires
3. Flagging at NHS Central Register
4. Six monthly Review by GP
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Primary outcome measure(s)
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Fatal or non-fatal disabling stroke (ischaemic or haemorrhagic) or significant systemic embolism.
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Secondary outcome measure(s)
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Hospitalisation or death as a result of non-intracranial haemorrhage; death (all cause); admission to hospital (all cause); quality of life (SF-12 & Euroquol 5D); Disability (Rankin score).
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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1. 2003 protocol in http://www.ncbi.nlm.nih.gov/pubmed/12939169
2. 2007 main results in http://www.ncbi.nlm.nih.gov/pubmed/17693178
3. 2007 secondary analysis in http://www.ncbi.nlm.nih.gov/pubmed/16887213
4. 2010 recruitment analysis in http://www.ncbi.nlm.nih.gov/pubmed/20610490
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Contact name
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Dr
Jonathan
Mant
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Address
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Department of Primary Care & General Practice
University of Birmingham
The Medical School
Vincent Drive
Edgbaston
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City/town
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Birmingham
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Zip/Postcode
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B15 2TT
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Country
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United Kingdom
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Email
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Sponsor
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University of Birmingham (UK)
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Address
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Edgbaston
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City/town
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Birmingham
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Zip/Postcode
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B15 2TT
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Country
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United Kingdom
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Email
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Sponsor website:
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http://www.bham.ac.uk/
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Date applied
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23/10/2000
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Last edited
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02/08/2010
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Date ISRCTN assigned
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23/10/2000
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