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Not yet recruiting NCT06476301

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

Phase IV Interventional Anticoagulation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rivaroxaban.
Who it may be relevant to
Registry conditions: Anticoagulation. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Safety of Rivaroxaban in the Early Postoperative Period for Patients With Bioprosthetic Valves: A Prospective, Randomized, Controlled Non-Inferiority Trial

Overview

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.

Interventions

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

Primary outcome measures

  • all-cause death [Time frame: 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) [Time frame: 0.5, 1, 3, and 6 months]
  • Major bleeding [Time frame: 0.5, 1, 3, and 6 months]
Secondary outcome measures (3)
  • Thromboembolic events (stroke, TIA, deep venous thrombosis, pulmonary embolism, non-CNS systemic embolism, valve thrombosis). [Time frame: 0.5, 1, 3, and 6 months]
  • Cardiovascular causes death [Time frame: 0.5, 1, 3, and 6 months]
  • Major bleeding events and clinically relevant non-major (CRNM) bleeding events and minor bleeding events [Time frame: 0.5, 1, 3, and 6 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • Uncontrolled severe hypertension
  • Active malignancy
  • Medication-related
  • Hypersensitivity or contraindications to Rivaroxaban, VKA, heparin.
  • Concomitant treatment with strong inhibitors of both CYP3A4 and P-gp (e.g., azole antifungals, such as ketoconazole and itraconazole, or HIV protease inhibitors, such as ritonavir)
  • Concomitant treatment with strong inducers of CYP3A4 (e.g., carbamazepine, phenytoin, rifampin, etc.)
  • HAS-BLED score>3
  • Others
  • Abnormal local laboratory results, such as Platelet count < 50 x109/L、Hemoglobin < 8 g/dL (5 mmol/L)
  • Female subjects of childbearing potential without using adequate contraception、
  • Female pregnant or breast-feeding
  • Participation is not likely to comply with the study procedures or will complete follow-up
  • Participation in another clinical trial that potentially interferes with the current study
  • Life expectancy less than 6 months beyond the targeted last visit

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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

Identifiers

NCT: NCT06476301 · IIT-2023-0325

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗