Contact information
Type
Scientific
Primary contact
Prof John Cleland
ORCID ID
Contact details
Castle Hill Hospital
University of Hull
Cottingham
Kingston upon Hull
HU16 5UQ
United Kingdom
+44 (0)1482 624 083/084
J.G.Cleland@hull.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
D15
Study information
Scientific title
What is the most cost effective anti-thrombotic strategy to reduce mortality in heart failure? The WASH Study
Acronym
WASH Study
Study hypothesis
Heart 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
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
1. Aspirin
2. Wafarin
3. No anti-thrombotic treatment
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Deaths
2. Myocardial infarction
3. Stroke
4. Bleeding episodes
5. Dyspepsia
6. A number of laboratory tests
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/1995
Overall trial end date
30/09/1998
Reason abandoned
Eligibility
Participant inclusion criteria
Patients were being treated for heart failure, and had evidence of ventricular dysfunction to a defined level on echocardiography.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
279
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/11/1995
Recruitment end date
30/09/1998
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Castle Hill Hospital
Kingston upon Hull
HU16 5UQ
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
Results in http://www.ncbi.nlm.nih.gov/pubmed/15215806
Publication citations
-
Results
Cleland JG, Findlay I, Jafri S, Sutton G, Falk R, Bulpitt C, Prentice C, Ford I, Trainer A, Poole-Wilson PA, The Warfarin/Aspirin Study in Heart failure (WASH): a randomized trial comparing antithrombotic strategies for patients with heart failure., Am. Heart J., 2004, 148, 1, 157-164, doi: 10.1016/j.ahj.2004.03.010.