Rationale and design of a randomized, double‐blind, event‐driven, multicentre study comparing the efficacy and safety of oral rivaroxaban with placebo for reducing the risk of death, myocardial infarction or stroke in subjects with heart failure and significant coronary artery disease following an exacerbation of heart failure: the COMMANDER HF trial

Autor:	Stefan D. Anker, Mandeep R. Mehra, William M. Byra, Roger M. Mills, John G.F. Cleland, Faiez Zannad, Barry H. Greenberg, Mihai Gheorghiade, Dirk J. van Veldhuisen, Min Fu
Přispěvatelé:	Centre d'investigation clinique [Nancy] (CIC), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Défaillance Cardiovasculaire Aiguë et Chronique (DCAC), Department of Medicine [San Diego], University of California [San Diego] (UC San Diego), University of California-University of California, National Heart & Lung Institute, Imperial College London, Center for Cardiovascular Innovation, Feinberg School of Medicine, Northwestern University [Evanston]-Northwestern University [Evanston], University Medical Center Groningen [Groningen] (UMCG), Brigham and Women's Hospital [Boston], University Medical Center Göttingen (UMG), Janssen Research & Development, Cardiovascular Centre (CVC)
Rok vydání:	2015
Předmět:	Cardiac & Cardiovascular Systems Exacerbation IMPACT Myocardial Infarction Administration Oral heart failure Coronary Artery Disease Cardiorespiratory Medicine and Haematology antithrombotic Cardiovascular Coronary artery disease Rivaroxaban Risk Factors MESH: Risk Factors MESH: Double-Blind Method Prospective Studies MESH: Coronary Artery Disease Myocardial infarction THROMBIN GENERATION rivaroxaban OUTCOMES Ejection fraction MESH: Research Design Atrial fibrillation thrombin Thrombosis 3. Good health Stroke Survival Rate MESH: Myocardial Infarction Heart Disease Research Design 6.1 Pharmaceuticals Administration MESH: Administration Oral Cardiology Patient Safety MESH: Factor Xa Inhibitors Cardiology and Cardiovascular Medicine Life Sciences & Biomedicine MESH: Rivaroxaban coronary artery disease medicine.drug Oral medicine.medical_specialty MESH: Survival Rate Clinical Trials and Supportive Activities ANTICOAGULANTS COAGULATION 1102 Cardiovascular Medicine And Haematology MESH: Stroke WARFARIN Double-Blind Method [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system Clinical Research Internal medicine MANAGEMENT medicine Humans Heart Disease - Coronary Heart Disease Heart Failure Science & Technology MESH: Humans business.industry MORTALITY Evaluation of treatments and therapeutic interventions medicine.disease R1 MESH: Prospective Studies ASPIRIN Cardiovascular System & Hematology Heart failure MESH: Heart Failure Cardiovascular System & Cardiology business Factor Xa Inhibitors
Zdroj:	European Journal of Heart Failure European Journal of Heart Failure, Oxford University Press (OUP), 2015, 17 (7), pp.735-742. ⟨10.1002/ejhf.266⟩ European journal of heart failure, vol 17, iss 7 European Journal of Heart Failure, 17(7), 735-742. Wiley
ISSN:	1879-0844 1388-9842
Popis:	Aims: \ud \ud 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.\ud Methods: \ud \ud 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.\ud Conclusion: \ud \ud COMMANDER HF is the first prospective study of a target-specific oral antithrombotic agent in HF. It will provide important information regarding rivaroxaban use following an HF event in an HF-rEF patient population with coronary artery disease.
Databáze:	OpenAIRE
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