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

NCT ID: NCT06476301

Last Updated: 2024-06-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

warfarin group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

rivaroxaban group

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).

Group Type: EXPERIMENTAL

Rivaroxaban

Intervention Type: DRUG

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

Interventions

Rivaroxaban

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Bo Xie

Role: CONTACT

xieborj@hotmail.com

021-68383761

Xin Wang

Role: CONTACT

15656594127@163.com

13052395835

References

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.

Reference Type: DERIVED

PMID: 39900192 (View on PubMed)

Other Identifiers

IIT-2023-0325

Identifier Type: -

Identifier Source: org_study_id