Rationale and Design of the H-REPLACE Study: Safety and Efficacy of LMWH Versus Rivaroxaban in ChinEse Patients HospitaL
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ORIGIN ARTICLE
Rationale and Design of the H-REPLACE Study: Safety and Efficacy of LMWH Versus Rivaroxaban in ChinEse Patients HospitaLized with Acute Coronary SyndromE Yichao Xiao 1 & Liang Tang 1 & Qiming Liu 1 & Xinqun Hu 1 & Zhenfei Fang 1 & Shenghua Zhou 1 Accepted: 7 September 2020 # Springer Science+Business Media, LLC, part of Springer Nature 2020
Abstract Background Acute coronary syndrome (ACS) is a serious and life-threatening condition. Anticoagulation during the acute phase of ACS is effective in reducing ischemic events. The most widely used parenteral anticoagulation agent in ACS patients is enoxaparin. Rivaroxaban is a novel oral anticoagulant with potent anti-Xa activity, which might be an attractive alternative drug to enoxaparin. In fact, rivaroxaban was consistently shown to be non-inferior to enoxaparin therapy in terms of reduction of recurrent venous thromboembolism events. Objective This prospective, randomized, open-label, active-controlled, multicenter study is designed to compare the safety and efficacy of rivaroxaban versus enoxaparin in patients with ACS, who missed the primary reperfusion therapy window and before selective revascularization. Methods and Results Up to 2055 participants receiving background treatment of aspirin plus clopidogrel or ticagrelor will be randomly assigned to either oral rivaroxaban 2.5 mg twice daily or rivaroxaban 5 mg twice daily or subcutaneous enoxaparin 1 mg/kg twice daily until hospital discharge for a maximum of 8 days or 12 h before revascularization therapy. The primary safety endpoint is the International Society on Thrombosis and Hemostasis definition of bleeding events [minor, clinically relevant nonmajor and major bleeding]. The primary efficacy endpoint is a composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction, re-revascularization or stroke, and major bleeding events. Secondary endpoints include cardiac-related rehospitalization and all-cause death. Patients will be followed for 12 months after randomization. Conclusions The H-REPLACE trial offers an opportunity to assess clinical outcomes of rivaroxaban versus enoxaparin during the acute phase of ACS and may provide an alternative anticoagulation strategy for ACS patients, who missed the primary reperfusion therapy window and before selective revascularization. Trial Registration ClinicalTrials.gov; NCT03363035. Keywords Acute coronary syndrome . Rivaroxaban . Enoxaparin . Antithrombotic therapy
Introduction Acute coronary syndrome (ACS) is a serious and lifethreatening condition characterized by the sudden onset of Electronic supplementary material The online version of this article (https://doi.org/10.1007/s10557-020-07076-9) contains supplementary material, which is available to authorized users. * Shenghua Zhou [email protected] 1
Department of Cardiology, The Second Xiangya Hospital of Central South University, Changsha, Hunan 410011, People’s Republic of China
coronary insufficiency because of thrombotic occlusion of one or more cor
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