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
| ISRCTN | ISRCTN89345269 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89345269 |
| Protocol serial number | G9900264 |
| Sponsor | University of Birmingham (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- Submission date
- 23/10/2000
- Registration date
- 23/10/2000
- Last edited
- 27/03/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jonathan Mant
Scientific
Scientific
Department of Primary Care & General Practice
University of Birmingham
The Medical School
Vincent Drive
Edgbaston
Birmingham
B15 2TT
United Kingdom
| abc@email.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study acronym | BAFTA |
| Study objectives | 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(s) | NRES Committee North West - Lancaster, 21/03/2013, REC ref: 13/NW/0233 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Warfarin, aspirin |
| Primary outcome measure(s) | Fatal or non-fatal disabling stroke (ischaemic or haemorrhagic) or significant systemic embolism |
| Key secondary outcome measure(s) | 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) |
| Completion date | 01/06/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 973 |
| Key inclusion criteria | 1. Age 75 or over 2. Non-rheumatic atrial fibrillation confirmed by electrocardiogram (ECG) |
| Key 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 |
| Date of first enrolment | 01/10/1999 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University of Birmingham
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | main results | 11/08/2007 | Yes | No | |
| Results article | results | 01/05/2014 | Yes | No | |
| Protocol article | protocol | 26/08/2003 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | secondary analysis | 25/04/2007 | Yes | No | |
| Other publications | recruitment analysis | 01/12/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
27/03/2018: Ethics approval information, publication and dissemination plan and IPD sharing statement added.
23/03/2018: The overall trial end date was changed from 31/12/2006 to 01/06/2019.
