Ignite Creation Date:
2024-05-06 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03363035
Status:
COMPLETED
Last Update Posted:
2022-02-22
First Post:
2017-11-29
Brief Title:
Safety and Efficacy of LMWH Versus Rivaroxaban in Chinese Patients Hospitalized With Acute Coronary Syndrome
Sponsor:
Second Xiangya Hospital of Central South University
Organization:
Second Xiangya Hospital of Central South University
Study Overview
Official Title:
Safety and Efficacy of Low Molecular Weight Heparin Versus Rivaroxaban in Chinese Patients Hospitalized With Acute Coronary SyndromeH-REPLACE a Prospective Randomized Open-label Active-controlled Multicenter Trial
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
H-REPLACE
Brief 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 25 mg twice daily or rivaroxaban 5 mg twice daily or subcutaneous SC enoxaparin 1mgkg twice daily until hospital discharge or 12 hours before revascularization therapy for a maximum of 8 days
Detailed Description:
Acute coronary syndrome ACS is a serious and life threatening condition Anticoagulation during the acute phase of ACS is effective in reducing ischaemic events The combination regimen of anticoagulation with dual antiplatelet therapy DAPT strategy is more effective than either treatment alone The most widely used parenteral anticoagulation agent in ACS patients is enoxaparin 1 mgkg administered subcutaneously twice daily
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 aimed to reduce the event of recurrent venous thromboembolism Moreover the bleeding risk of low dose of rivaroxaban is low and acceptable 10-25 during the acute phase of ACS as shown by ATLAS ACS-TIMI 46 Trial and the bleeding risk of enoxaparin during the acute phase of ACS was 43 as shown in a meta-analysis
We thus hypothesized that the safety and efficacy of rivaroxaban during the acute phase of ACS is non-inferior to enoxaparin and designed this prospective randomized open-label active-controlled multicenter study in participants with ACS STEMI or NSTEMI or unstable angina All eligible participants receiving background treatment of aspirin plus clopidogrel or ticagrelor will be randomly assigned to either receive oral rivaroxaban 25 mg twice daily or oral rivaroxaban 5 mg twice daily or enoxaparin 1mgkg twice daily SC until hospital discharge or 12 hours before revascularization therapy for a maximum of 8 days
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 aimed to reduce the event of recurrent venous thromboembolism Moreover the bleeding risk of low dose of rivaroxaban is low and acceptable 10-25 during the acute phase of ACS as shown by ATLAS ACS-TIMI 46 Trial and the bleeding risk of enoxaparin during the acute phase of ACS was 43 as shown in a meta-analysis
We thus hypothesized that the safety and efficacy of rivaroxaban during the acute phase of ACS is non-inferior to enoxaparin and designed this prospective randomized open-label active-controlled multicenter study in participants with ACS STEMI or NSTEMI or unstable angina All eligible participants receiving background treatment of aspirin plus clopidogrel or ticagrelor will be randomly assigned to either receive oral rivaroxaban 25 mg twice daily or oral rivaroxaban 5 mg twice daily or enoxaparin 1mgkg twice daily SC until hospital discharge or 12 hours before revascularization therapy for a maximum of 8 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None