Efficacy and Safety of Rivaroxaban in the Early Postoperative Period for Patients With Bioprosthetic Valves

NCT06476301 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: IIT-2023-0325
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Anticoagulation

Keywords

warfarin; rivaroxaban; Bioprosthetic valve; anticoagulation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Thromboembolic events (stroke, TIA, deep venous thrombosis, pulmonary embolism, non-CNS systemic embolism, valve thrombosis).

  0.5, 1, 3, and 6 months

• Cardiovascular causes death

  0.5, 1, 3, and 6 months

• Major bleeding events and clinically relevant non-major (CRNM) bleeding events and minor bleeding events

  0.5, 1, 3, and 6 months

Study Arms (2)

warfarin group

NO INTERVENTION

A 3-6-month anticoagulation therapy with warfarin is recommended after the BPV surgery. Patients allocated to the warfarin group will adhere to a target INR range of 2 to 3. Patients 65 \> years old and low weight should take warfarin 2.5mg/day and all other patients should take 5mg/day. During hospitalization, the INR will be reassessed daily, and regular measurements (at least every four weeks) should be conducted post-discharge to ensure ongoing patient stability.

rivaroxaban group

EXPERIMENTAL

Patients allocated to the rivaroxaban group will be administered a dose of 20 mg orally once daily (to be taken with food), or 15 mg once daily in patients with moderate renal impairment at screening (defined as creatinine clearance rate, CrCl between 30 and 49 mL/min).

Drug: Rivaroxaban

Interventions

Rivaroxaban DRUG

To compare the efficacy and safety of rivaroxaban as an early anticoagulant therapy for BPV patients with the traditional postoperative anticoagulant warfarin

rivaroxaban group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 80 years
• Patients who underwent successful surgical bioprosthetic valve replacement or repair to either the mitral, aortic position or both
• Signed informed consent

You may not qualify if:

• Aged below 18 or over 80 years
• Mechanical heart valves (MHV)
• Bioprosthetic valve transcatheter valve replacement (TAVR)
• Hemorrhage risk-related criteria
• Active internal bleeding
• Major surgical procedure or trauma within 30 days before the randomization visit
• History of intracranial, intraocular, spinal, gastrointestinal, or atraumatic intra-articular bleeding
• Chronic hemorrhagic disorder
• Planned invasive procedure with potential for uncontrolled bleeding, including major surgery
• Concomitant conditions and therapies
• Clinically overt stroke within the past 3 months
• Major surgery within 1 month
• Acute coronary syndrome within 1 month
• Active infective endocarditis
• Severe hepatic impairment、hepatic disease associated with coagulopathy or Moderate and severe hepatic impairment (Child-Pugh Class B or C)

Sponsors & Collaborators

• RenJi Hospital: lead

Related Publications (1)

• Wang X, Zhang C, Pan MM, Lin HW, Xue S, Xie B, Gu ZC. Design and rationale of the multicenter randomized clinical trial (REVERSE): Efficacy and safety of rivaroxaban in the early postoperative period for patients with bioprosthetic valve replacement or valve repair. Int J Cardiol. 2025 Apr 15;425:133023. doi: 10.1016/j.ijcard.2025.133023. Epub 2025 Feb 1.

  PMID: 39900192 DERIVED

MeSH Terms

Interventions

Rivaroxaban

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Bo Xie

CONTACT

021-68383761; xieborj@hotmail.com

Xin Wang

CONTACT

13052395835; 15656594127@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 26, 2024
• Study Start: August 1, 2024
• Primary Completion: February 28, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share