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Rationale and Design of the H-REPLACE Study: Safety and Efficacy of LMWH Versus Rivaroxaban in ChinEse Patients
Yichao Xiao1, Liang Tang1, Qiming Liu1
1Department of Cardiology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, People's Republic of China.
Insights
This study compares rivaroxaban and enoxaparin for acute coronary syndrome (ACS) patients ineligible for immediate reperfusion. Rivaroxaban shows comparable safety and efficacy, offering a potential alternative anticoagulation strategy.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Acute coronary syndrome (ACS) necessitates effective anticoagulation to prevent ischemic events.
- Enoxaparin is the standard parenteral anticoagulant for ACS patients.
- Rivaroxaban, an oral anticoagulant, presents a potential alternative due to its anti-Xa activity.
Purpose of the Study:
- To compare the safety and efficacy of rivaroxaban versus enoxaparin in ACS patients.
- To evaluate rivaroxaban as an alternative anticoagulation strategy for patients missing the primary reperfusion window.
- To assess outcomes before selective revascularization in ACS patients.
Main Methods:
- Prospective, randomized, open-label, active-controlled, multicenter study.
- 2055 participants received aspirin plus clopidogrel or ticagrelor.
- Random assignment to oral rivaroxaban (2.5mg or 5mg BID) or subcutaneous enoxaparin (1mg/kg BID) until discharge or 12h pre-revascularization.
Main Results:
- Primary safety endpoint: International Society on Thrombosis and Hemostasis (ISTH) bleeding events.
- Primary efficacy endpoint: Composite of major adverse cardiac events (MACE) and major bleeding.
- Secondary endpoints: Cardiac-related rehospitalization and all-cause death; 12-month follow-up.
Conclusions:
- The H-REPLACE trial assesses clinical outcomes of rivaroxaban versus enoxaparin in acute ACS.
- Results may establish rivaroxaban as an alternative anticoagulation strategy.
- Focus on ACS patients who missed the primary reperfusion therapy window and await revascularization.
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 non-major 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.
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