drugset / Trial / NCT03363035

Safety and Efficacy of LMWH Versus Rivaroxaban in Chinese Patients Hospitalized With Acute Coronary Syndrome

NCT03363035

Phase 4 Completed 2055 enrolled Second Xiangya Hospital of Central South University
RandomizedParallel-groupOpen-labelTreatment

Summary

H-REPLACE trial is a prospective, randomized, open-label, active-controlled, multicenter study in participants with ACS (STEMI or NSTEMI, unstable angina). All eligible 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 (SC) enoxaparin 1mg/kg twice daily until hospital discharge or 12 hours before revascularization therapy for a maximum of 8 days.

Timeline

Start
2018-01-15
Primary completion
2021-11-11
Completion
2021-11-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Enoxaparin sodium Other / unclassified 1 mg/kg Subcutaneous
Subject Rivaroxaban Other / unclassified 2.5 mg Oral
Subject Rivaroxaban Other / unclassified 5 mg Oral