Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9900264
Study information
Scientific title
Acronym
BAFTA
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Atrial fibrillation in primary care
Intervention
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
Intervention type
Drug
Phase
Phase IV
Drug names
Warfarin, aspirin
Primary outcome measures
Fatal or non-fatal disabling stroke (ischaemic or haemorrhagic) or significant systemic embolism.
Secondary outcome measures
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).
Overall trial start date
01/10/1999
Overall trial end date
31/12/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age 75 or over
2. Non-rheumatic atrial fibrillation confirmed by electrocardiogram (ECG)
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
973
Participant 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
Recruitment start date
01/10/1999
Recruitment end date
31/12/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Primary Care & General Practice
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
University of Birmingham (UK)
Sponsor details
Edgbaston
Birmingham
B15 2TT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication 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
Publication citations
-
Recruitment analysis
Fletcher K, Mant J, Roalfe A, Hobbs FD, Impact of study design on recruitment of patients to a primary care trial: an observational time series analysis of the Birmingham Atrial Fibrillation Treatment of the Aged (BAFTA) study., Fam Pract, 2010, 27, 6, 691-697, doi: 10.1093/fampra/cmq050.
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Results
Mavaddat N, Roalfe A, Fletcher K, Lip GY, Hobbs FD, Fitzmaurice D, Mant J, Warfarin versus aspirin for prevention of cognitive decline in atrial fibrillation: randomized controlled trial (Birmingham Atrial Fibrillation Treatment of the Aged Study)., Stroke, 2014, 45, 5, 1381-1386, doi: 10.1161/STROKEAHA.113.004009.
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Mant JW, Richards SH, Hobbs FD, Fitzmaurice D, Lip GY, Murray E, Banting M, Fletcher K, Rahman J, Allan T, Raftery J, Bryan S, , Protocol for Birmingham Atrial Fibrillation Treatment of the Aged study (BAFTA): a randomised controlled trial of warfarin versus aspirin for stroke prevention in the management of atrial fibrillation in an elderly primary care population [ISRCTN89345269]., BMC Cardiovasc Disord, 2003, 3, 9, doi: 10.1186/1471-2261-3-9.
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Mant J, Hobbs FD, Fletcher K, Roalfe A, Fitzmaurice D, Lip GY, Murray E, , , Warfarin versus aspirin for stroke prevention in an elderly community population with atrial fibrillation (the Birmingham Atrial Fibrillation Treatment of the Aged Study, BAFTA): a randomised controlled trial., Lancet, 2007, 370, 9586, 493-503, doi: 10.1016/S0140-6736(07)61233-1.
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Hurley V, Ireson R, Fletcher K, Lip GY, Hobbs FD, Mant J, , A cross-sectional study of hypertension in an elderly population (75 years and over) with atrial fibrillation: secondary analysis of data from the Birmingham Atrial Fibrillation in the Aged (BAFTA) randomised controlled trial., Int. J. Cardiol., 2007, 117, 2, 152-156, doi: 10.1016/j.ijcard.2006.04.061.