Abstract | AIMS:
Thrombin is a critical element of crosstalk between pathways contributing to worsening of established heart failure (HF). The aim of this study is to explore the efficacy and safety of rivaroxaban 2.5 mg bid compared with placebo (with standard care) after an exacerbation of HF in patients with reduced ejection fraction (HF-rEF) and documented coronary artery disease. METHODS: This is an international prospective, multicentre, randomized, double-blind, placebo-controlled, event-driven study of approximately 5000 patients for a targeted 984 events. Patients must have a recent symptomatic exacerbation of HF, increased plasma concentrations of natriuretic peptides ( B-type natriuretic peptide ≥200 pg/mL or N-terminal pro- B-type natriuretic peptide ≥800 pg/mL), with left ventricular ejection fraction ≤40% and coronary artery disease. Patients requiring anticoagulation for atrial fibrillation or other conditions will be excluded. After an index event (overnight hospitalization, emergency department or observation unit admission, or unscheduled outpatient parenteral treatment for worsening HF), patients will be randomized 1:1 to rivaroxaban or placebo (with standard of care). The primary efficacy outcome event is a composite of all-cause mortality, myocardial infarction or stroke. The principal safety outcome events are the composite of fatal bleeding or bleeding into a critical space with potential permanent disability, bleeding events requiring hospitalization and major bleeding events according to International Society on Thrombosis and Haemostasis bleeding criteria. CONCLUSION:
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Authors | Faiez Zannad, Barry Greenberg, John G F Cleland, Mihai Gheorghiade, Dirk J van Veldhuisen, Mandeep R Mehra, Stefan D Anker, William M Byra, Min Fu, Roger M Mills |
Journal | European journal of heart failure
(Eur J Heart Fail)
Vol. 17
Issue 7
Pg. 735-42
(Jul 2015)
ISSN: 1879-0844 [Electronic] England |
PMID | 25919061
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2015 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology. |
Chemical References |
- Factor Xa Inhibitors
- Rivaroxaban
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Topics |
- Administration, Oral
- Coronary Artery Disease
(drug therapy, mortality)
- Double-Blind Method
- Factor Xa Inhibitors
(therapeutic use)
- Heart Failure
(drug therapy, mortality)
- Humans
- Myocardial Infarction
(prevention & control)
- Prospective Studies
- Research Design
- Risk Factors
- Rivaroxaban
(therapeutic use)
- Stroke
(prevention & control)
- Survival Rate
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