ISRCTN ISRCTN17465143
DOI https://doi.org/10.1186/ISRCTN17465143
Protocol serial number MC7
Sponsor Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Funder NHS Cardiovascular Disease and Stroke National Research and Development Programme (UK)
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
30/08/2012
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

Prof Gareth Beevers
Scientific

University Department of Medicine
City Hospital
Dudley Rd
Birmingham
B18 7QH
United Kingdom

Phone +44 (0)121 507 5080

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesPrevious studies have demonstrated increased markers of thrombogenesis in patients with atrial fibrillation (AF), suggesting the presence of a hypercoaguable or prothromobotic state. The objective of this study was to determine the effects of introducing ultra-low-dose warfarin (1 mg), conventional warfarin, and aspirin (300 mg) therapy on thrombogenesis and platelet activation in AF.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedHeart disease
Intervention3 treatment arms:
1. Ultra-low-dose warfarin (1 mg)
2. Conventional warfarin
3. Aspirin (300 mg)
Intervention typeDrug
PhaseNot Specified
Drug / device / biological / vaccine name(s)Warfarin, aspirin
Primary outcome measure(s)

Platelet activation

Key secondary outcome measure(s)

Not provided at time of registration

Completion date01/04/1996

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Key inclusion criteriaPatients with atrial fibrillation
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment01/04/1994
Date of final enrolment01/04/1996

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

University Department of Medicine
Birmingham
B18 7QH
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 01/08/1996 Yes No