Warfarin versus Aspirin in Reduced Ejection Fraction (WARCEF) - Project description
Background
Patients with severe chronic heart failure have a poor prognosis for survival and high morbidity. The stroke volume and ejection fraction are standard measurements for the degree of reduction in cardiac function. Thus, in patients with chronic heart failure a reduced ejection fraction less than or equal to 35 percent represents a significant risk factor for mortality and the occurrence of a stroke. However, it is still unclear what the optimal treatment strategy for the prevention of a stroke in patients with heart failure and/or a reduced ejection fraction is. Several international studies have compared the effects of the anticoagulant substances warfarin and aspirin in reducing the frequency of strokes and mortality. However, these were not heart failure studies.
The WATCH study (Warfarin and Antiplatelet Therapy in Chronic Heart Failure), the goal of which was to compare the effectiveness of warfarin, aspirin and clopidogrel specifically against the background of cardiac insufficiency, was discontinued without a clear result due to lack of recruitment.
Objective
The study was designed to investigate whether there is a difference between treatment with aspirin and warfarin in patients with a reduced stroke volume and/or a low ejection fraction within three to five years with regard to the occurrence of the combined end point death and/or ischemic stroke and/or intracerebral hemorrhaging.
Implementation
WARCEF is a two-arm, double-blind, randomized, multicentric and international clinical trial with a total of 3,000 patients in over 80 centers in the United States and in more than 80 centers in Europe. Patients with a reduced ejection fraction (LVEF ≤ 35%) receive either warfarin or aspirin after randomization.
Added value via networking
In Germany, Poland and the Netherlands, a total of 850 patients were to be enrolled in the study. After nearly 4 years (December 2004 – September 2008) a total of 450 patients in 10 German, 12 Polish and 9 Dutch centers were enrolled.
The networking in the Heart Failure Competence Network was intended to ensure successful recruitment. The research resources of the National Institutes of Health were to support the German research perspective. As a result of the collaboration among German, Polish and Dutch study centers, an extensive blood database has been established.