drugset / Trial / NCT03363035
Safety and Efficacy of LMWH Versus Rivaroxaban in Chinese Patients Hospitalized With Acute Coronary Syndrome
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
Publications
- Zhang Q, Ding H, Dai Z, Yang R, Zhou S, Tai S. U-shaped association between plasma cyclic guanosine monophosphate-adenosine monophosphate (cGAMP) levels and myocardial infarction. BMC Cardiovasc Disord. 2025 Feb 19;25(1):116. doi: 10.1186/s12872-025-04543-9.
- Zhou S, Xiao Y, Zhou C, Zheng Z, Jiang W, Shen Q, Zhu C, Pan H, Liu C, Zeng G, Ge L, Zhang Y, Ouyang Z, Fu G, Pan G, Chen F, Huang L, Liu Q; H-REPLACE Investigators. Effect of Rivaroxaban vs Enoxaparin on Major Cardiac Adverse Events and Bleeding Risk in the Acute Phase of Acute Coronary Syndrome: The H-REPLACE Randomized Equivalence and Noninferiority Trial. JAMA Netw Open. 2023 Feb 1;6(2):e2255709. doi: 10.1001/jamanetworkopen.2022.55709.
- Xiao Y, Tang L, Liu Q, Hu X, Fang Z, Zhou S. Rationale and Design of the H-REPLACE Study: Safety and Efficacy of LMWH Versus Rivaroxaban in ChinEse Patients HospitaLized with Acute Coronary SyndromE. Cardiovasc Drugs Ther. 2022 Feb;36(1):69-73. doi: 10.1007/s10557-020-07076-9. Epub 2020 Sep 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Enoxaparin sodium | Other / unclassified | 1 mg/kg | Subcutaneous |
| Subject | Rivaroxaban | Other / unclassified | 2.5 mg | Oral |
| Subject | Rivaroxaban | Other / unclassified | 5 mg | Oral |