Efficacy and Safety of Rivaroxaban in the Early Postoperative Period for Patients With Bioprosthetic Valves
NCT Number: NCT06476301
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Anticoagulation
Interventions: DRUG: Rivaroxaban
Sponsor: RenJi Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-01
Completion Date: 2026-12-31

Summary:
this study aims to comprehensively evaluate the efficacy and safety profiles of rivaroxaban and warfarin during the initial postoperative period following surgical bioprosthetic valve in patients.

Primary Outcome Measures: all-cause death, Patients will be scheduled for outpatient clinic or phone visits at intervals of 0.5, 1, 3, and 6 months following enrollment. During these visits, patients will be instructed to document any symptoms indicative of clinical thromboembolic or bleeding events. If such symptoms are reported, patients may undergo necessary diagnostic and laboratory testing. Cardiac CT and transthoracic echocardiography will be conducted at the 3-month and 6-month marks post-randomization., 0.5, 1, 3, and 6 months|Major cardiovascular events (stroke, transient ischemic attack (TIA), valve thrombosis, systemic embolism not related to the central nervous system (CNS), hospitalization due to heart failure), Patients will be scheduled for outpatient clinic or phone visits at intervals of 0.5, 1, 3, and 6 months following enrollment. During these visits, patients will be instructed to document any symptoms indicative of clinical thromboembolic or bleeding events. If such symptoms are reported, patients may undergo necessary diagnostic and laboratory testing. Cardiac CT and transthoracic echocardiography will be conducted at the 3-month and 6-month marks post-randomization., 0.5, 1, 3, and 6 months|Major bleeding, Patients will be scheduled for outpatient clinic or phone visits at intervals of 0.5, 1, 3, and 6 months following enrollment. During these visits, patients will be instructed to document any symptoms indicative of clinical thromboembolic or bleeding events. If such symptoms are reported, patients may undergo necessary diagnostic and laboratory testing. Cardiac CT and transthoracic echocardiography will be conducted at the 3-month and 6-month marks post-randomization., 0.5, 1, 3, and 6 months
Secondary Outcome Measures: Thromboembolic events (stroke, TIA, deep venous thrombosis, pulmonary embolism, non-CNS systemic embolism, valve thrombosis)., The Efficacy endpoint was defined as the composite of death from cardiovascular causes or Patients will be scheduled for outpatient clinic or phone visits at intervals of 0.5, 1, 3, and 6 months following enrollment. During these visits, patients will be instructed to document any symptoms indicative of clinical thromboembolic or bleeding events. If such symptoms are reported, patients may undergo necessary diagnostic and laboratory testing. Cardiac CT and transthoracic echocardiography will be conducted at the 3-month and 6-month marks post-randomization., 0.5, 1, 3, and 6 months|Cardiovascular causes death, Patients will be scheduled for outpatient clinic or phone visits at intervals of 0.5, 1, 3, and 6 months following enrollment. During these visits, patients will be instructed to document any symptoms indicative of clinical thromboembolic or bleeding events. If such symptoms are reported, patients may undergo necessary diagnostic and laboratory testing. Cardiac CT and transthoracic echocardiography will be conducted at the 3-month and 6-month marks post-randomization., 0.5, 1, 3, and 6 months|Major bleeding events and clinically relevant non-major (CRNM) bleeding events and minor bleeding events, Patients will be scheduled for outpatient clinic or phone visits at intervals of 0.5, 1, 3, and 6 months following enrollment. During these visits, patients will be instructed to document any symptoms indicative of clinical thromboembolic or bleeding events. If such symptoms are reported, patients may undergo necessary diagnostic and laboratory testing. Cardiac CT and transthoracic echocardiography will be conducted at the 3-month and 6-month marks post-randomization., 0.5, 1, 3, and 6 months