Clinical trial NCT06476301: Efficacy and Safety of Rivaroxaban in the Early Postoperative Period for Patients With Bioprosthetic Valves
Official title: Efficacy and Safety of Rivaroxaban in the Early Postoperative Period for Patients With Bioprosthetic Valves: A Prospective, Randomized, Controlled Non-Inferiority Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Anticoagulation
Keywords: warfarin
rivaroxaban
Bioprosthetic valve
anticoagulation
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

  1. Active internal bleeding
  2. Major surgical procedure or trauma within 30 days before the randomization visit
  3. History of intracranial, intraocular, spinal, gastrointestinal, or atraumatic intra-articular bleeding
  4. Chronic hemorrhagic disorder
  5. Planned invasive procedure with potential for uncontrolled bleeding, including major surgery
* Concomitant conditions and therapies

  1. Clinically overt stroke within the past 3 months
  2. Major surgery within 1 month
  3. Acute coronary syndrome within 1 month
  4. Active infective endocarditis
  5. Severe hepatic impairment、hepatic disease associated with coagulopathy or Moderate and severe hepatic impairment (Child-Pugh Class B or C)
  6. Uncontrolled severe hypertension
  7. Active malignancy
* Medication-related

  1. Hypersensitivity or contraindications to Rivaroxaban, VKA, heparin.
  2. 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)
  3. Concomitant treatment with strong inducers of CYP3A4 (e.g., carbamazepine, phenytoin, rifampin, etc.)
* HAS-BLED score\>3
* Others

  1. Abnormal local laboratory results, such as Platelet count \< 50 x109/L、Hemoglobin \< 8 g/dL (5 mmol/L)
  2. Female subjects of childbearing potential without using adequate contraception、
  3. Female pregnant or breast-feeding
  4. Participation is not likely to comply with the study procedures or will complete follow-up
  5. Participation in another clinical trial that potentially interferes with the current study
  6. Life expectancy less than 6 months beyond the targeted last visit

Primary outcomes:
measure: all-cause death
timeFrame: 0.5, 1, 3, and 6 months
measure: 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)
timeFrame: 0.5, 1, 3, and 6 months
measure: Major bleeding
timeFrame: 0.5, 1, 3, and 6 months
Secondary outcomes:
measure: Thromboembolic events (stroke, TIA, deep venous thrombosis, pulmonary embolism, non-CNS systemic embolism, valve thrombosis).
timeFrame: 0.5, 1, 3, and 6 months
measure: Cardiovascular causes death
timeFrame: 0.5, 1, 3, and 6 months
measure: Major bleeding events and clinically relevant non-major (CRNM) bleeding events and minor bleeding events
timeFrame: 0.5, 1, 3, and 6 months
Other outcomes:
Locations:
Study officials:
References: