A comparison of warfarin and aspirin for stroke prevention in octogenarians in atrial fibrillation study

ISRCTN ISRCTN36280307
DOI https://doi.org/10.1186/ISRCTN36280307
Protocol serial number N0164097348
Sponsor Department of Health (UK)
Funder Northern General Hospital NHS Trust (UK)
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
06/01/2009
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 KS Channer
Scientific

Royal Hallamshire Hospital NHS Trust
M Floor
Glossop Road
Sheffield
S10 2JF
United Kingdom

Phone +44 (0)114 271 3473

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesTo determine whether warfarin or aspirin is better in the prevention of strokes.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCardiovascular: Stroke
InterventionWwarfarin or aspirin
Intervention typeOther
Primary outcome measure(s)

1. Comparative frequency of embolic events
2. Comparative frequency of serious bleeding
3. Death
4. Refusal to continue
5. Adverse events

Key secondary outcome measure(s)

Not provided at time of registration

Completion date24/04/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration200
Key inclusion criteria200 patients in total aged between 80 and 89 years, with persistant or permanent atrial fibrillation.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment24/04/2001
Date of final enrolment24/04/2003

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Royal Hallamshire Hospital NHS Trust
Sheffield
S10 2JF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/03/2007 Yes No