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

Shanghai Jiao Tong University

Status and phase: Not yet enrolling; Phase 4

Conditions: Anticoagulation

Treatments: Drug: Rivaroxaban

Study type: Interventional

Funder types: Other

Identifiers

NCT06476301

IIT-2023-0325

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

warfarin group

No Intervention group

Description:

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 group

Description:

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).

Treatment:

Drug: Rivaroxaban