The WASH study (Warfarin/Aspirin Study in Heart failure) rationale, designand end-points

Background: Athero-thrombotic events are common among patients with heart f ailure but there is no evidence that anti-thrombotic therapy is safe or eff ective in this clinical setting. Aims and Methods: The WASH study is a pros pective, randomised, open-label, blinded-end-point pilot study comparing th e outcome of management without anti-thrombotic therapy compared to treatme nt with aspirin or warfarin in three parallel arms in patients with chronic heart failure due to left ventricular systolic dysfunction. The primary ai m of the study is to assess the feasibility of conducting a large study in which one-third of patients would be randomised to no anti-thrombotic thera py. The principal secondary aim of the study is to compare the effects of t reatment on the combined end-point of death, non-fatal myocardial infarctio n and non-fatal stroke. Results: 279 patients have been randomised and by s tudy close there were 626 patient-years of follow-up. The majority of patie nts randomised had heart failure secondary to coronary artery disease. We e xpect to commence data analysis in early 1999 and report later in that year . Conclusions: This pilot study demonstrated that it is technically feasibl e to conduct a study that included a no anti-thrombotic treatment arm but t hat recruitment to such a study would be slow and costly. A large trial com paring the effects of aspirin, warfarin and clopidogrel in three separate g roups without a placebo arm is now intended. (C) 1999 European Society of C ardiology. All rights reserved.