It is uncertain whether anti-thrombotic treatment reduces the incidence
of thrombo-embolism in patients with heart failure, so there is a need
for a large scale controlled study to assess the effects of
anti-thrombotic therapy in this setting. We report the design of a
randomized controlled multicenter double blind trial examining the
effects of aspirin, warfarin and placebo in patients with heart failure
on the risk of thrombo-embolism. We planned to recruit 6000 patients
with heart failure without contraindications to anticoagulants or
antiplatelet agents and to follow them for a mean time of 2 years
following randomization. The study was planned to determine the rate of
thrombo-embolic and haemorrhagic events and death among patients
randomized to aspirin, warfarin and placebo, stratified according to the
presence or absence of underlying coronary disease. Ancillary studies
parallel to the main study will attempt to identify clinical and
echocardiographic risk factors for thrombo-embolism and will also
examine whether hemostatic or neurohormonal mechanisms contribute to an
increase in the risk of thrombo-embolism in patients with heart failure.
We hoped that the results of the study would improve the clinical
management and cost-effectiveness of treatment for patients with heart
failure. However, the recruitment of patients proved more difficult than
expected and a number of centers decided not to participate. To avoid a
great delay it was decided by the principal investigators and submitted
to the executive committee to terminate enrolment in this study when 300
patients had been enrolled, and accept that this is a pilot study. (C)
1999 European Society of Cardiology. All rights reserved.
