Condition category
Circulatory System
Date applied
23/10/2000
Date assigned
23/10/2000
Last edited
27/03/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.bham.ac.uk/

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Additional files

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.