ISRCTN ISRCTN76146656
DOI https://doi.org/10.1186/ISRCTN76146656
Protocol serial number D15
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
22/02/2008
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 John Cleland
Scientific

Castle Hill Hospital
University of Hull
Cottingham
Kingston upon Hull
HU16 5UQ
United Kingdom

Phone +44 (0)1482 624 083/084
Email J.G.Cleland@hull.ac.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific titleWhat is the most cost effective anti-thrombotic strategy to reduce mortality in heart failure? The WASH Study
Study acronymWASH Study
Study objectivesHeart failure is common and causes appreciable morbidity and mortality. It is associated with recurrent myocardial infarcts, strokes, and other thrombo-embolic events. For these reasons anti-thrombotic therapy using aspirin or warfarin is seen as normal clinical practice. However aspirin has a number of side-effects, and warfarin requires regular blood tests, increasing its cost and inconvenience for patients. Thus using these agents should be justified by clinical benefit. The aim of this study was to see if it would be possible to organise a trial of aspirin, warfarin, and no anti-thrombotic treatment.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedHeart disease
Intervention1. Aspirin
2. Wafarin
3. No anti-thrombotic treatment
Intervention typeOther
Primary outcome measure(s)

1. Deaths
2. Myocardial infarction
3. Stroke
4. Bleeding episodes
5. Dyspepsia
6. A number of laboratory tests

Key secondary outcome measure(s)

Not provided at time of registration

Completion date30/09/1998

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration279
Key inclusion criteriaPatients were being treated for heart failure, and had evidence of ventricular dysfunction to a defined level on echocardiography.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/11/1995
Date of final enrolment30/09/1998

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Castle Hill Hospital
Kingston upon Hull
HU16 5UQ
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 01/07/2004 Yes No