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NCT Number: NCT06476301

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

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.

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Key information

Conditions

Anticoagulation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban

Drug

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

Primary outcomes

  1. all-cause death

    Time frame: 0.5, 1, 3, and 6 months

    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.

  2. 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

    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.

  3. Major bleeding

    Time frame: 0.5, 1, 3, and 6 months

    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.

Secondary outcomes

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

    Time frame: 0.5, 1, 3, and 6 months

    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.

  2. Cardiovascular causes death

    Time frame: 0.5, 1, 3, and 6 months

    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.

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

    Time frame: 0.5, 1, 3, and 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bo Xie

CONTACT

[email protected]

021-68383761

Xin Wang

CONTACT

[email protected]

13052395835

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 26, 2024
Registry last updated
Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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