Contact information
Type
Scientific
Primary contact
Dr Jonathan Mant
ORCID ID
Contact details
Department of Primary Care & General Practice
University of Birmingham
The Medical School
Vincent Drive
Edgbaston
Birmingham
B15 2TT
United Kingdom
-
abc@email.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9900264
Study information
Scientific title
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
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
NRES Committee North West - Lancaster, 21/03/2013, REC ref: 13/NW/0233
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a 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 measure
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
01/10/1999
Overall trial end date
01/06/2019
Reason abandoned (if study stopped)
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
University of Birmingham
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
University of Birmingham (UK)
Sponsor details
Edgbaston
Birmingham
B15 2TT
United Kingdom
-
abc@email.com
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
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
01/02/2020
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
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
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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.