Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
30/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Gareth Beevers

ORCID ID

Contact details

University Department of Medicine
City Hospital
Dudley Rd
Birmingham
B18 7QH
United Kingdom
+44 (0)121 507 5080

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes