Dr Jonathan Mant
Department of Primary Care & General Practice
University of Birmingham
The Medical School
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
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.
NRES Committee North West - Lancaster, 21/03/2013, REC ref: 13/NW/0233
Randomised controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Atrial fibrillation in primary care
Patients will be randomised to:
1. Aspirin 75 mg daily
2. Warfarin, target international normalized ratio (INR) 2.5
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
Primary outcome measures
Fatal or non-fatal disabling stroke (ischaemic or haemorrhagic) or significant systemic embolism
Secondary outcome measures
1. Hospitalisation or death as a result of non-intracranial haemorrhage
2. Death (all cause)
3. Admission to hospital (all cause)
4. Quality of life (SF-12 & Euroqol 5D)
5. Disability (Rankin score)
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Age 75 or over
2. Non-rheumatic atrial fibrillation confirmed by electrocardiogram (ECG)
Target number of participants
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
Recruitment end date
Countries of recruitment
Trial participating centre
University of Birmingham
Medical Research Council (MRC) (UK)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
The results from the BAFTA(2) study will be submitted for planned publication in a high-impact peer reviewed journal.
IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
Participant level data
To be made available at a later date
Results - basic reporting
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
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.
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.
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.
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.
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.