Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MC7
Study information
Scientific title
Acronym
Study hypothesis
Previous 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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Heart disease
Intervention
3 treatment arms:
1. Ultra-low-dose warfarin (1 mg)
2. Conventional warfarin
3. Aspirin (300 mg)
Intervention type
Drug
Phase
Not Specified
Drug names
Warfarin, aspirin
Primary outcome measures
Platelet activation
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/1994
Overall trial end date
01/04/1996
Reason abandoned
Eligibility
Participant inclusion criteria
Patients with atrial fibrillation
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/04/1994
Recruitment end date
01/04/1996
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Department of Medicine
Birmingham
B18 7QH
United Kingdom
Sponsor information
Organisation
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Cardiovascular Disease and Stroke National Research and Development Programme (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 1996 results in http://www.ncbi.nlm.nih.gov/pubmed/8759084
Publication citations
-
Results
Lip GY, Lip PL, Zarifis J, Watson RD, Bareford D, Lowe GD, Beevers DG, Fibrin D-dimer and beta-thromboglobulin as markers of thrombogenesis and platelet activation in atrial fibrillation. Effects of introducing ultra-low-dose warfarin and aspirin., Circulation, 1996, 94, 3, 425-431.