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
Secondary identifying numbers	G9900264

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

Department of Primary Care & General Practice
University of Birmingham
The Medical School
Vincent Drive
Edgbaston
Birmingham
B15 2TT
United Kingdom

Email	abc@email.com

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient 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
Pharmaceutical study type(s)
Phase	Phase IV
Drug / device / biological / vaccine name(s)	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 study start date	01/10/1999
Completion date	01/06/2019

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	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

England
United Kingdom

Study participating centre

University of Birmingham

Birmingham
B15 2TT
United Kingdom

Sponsor information

University of Birmingham (UK)
University/education

Edgbaston
Birmingham
B15 2TT
England
United Kingdom

Email	abc@email.com
Website	http://www.bham.ac.uk/
"ROR"	https://ror.org/03angcq70

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date	01/02/2020
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
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 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?
Protocol article	protocol	26/08/2003		Yes	No
Other publications	secondary analysis	25/04/2007		Yes	No
Results article	main results	11/08/2007		Yes	No
Other publications	recruitment analysis	01/12/2010		Yes	No
Results article	results	01/05/2014		Yes	No
HRA research summary			28/06/2023	No	No

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.