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

Launched by RENJI HOSPITAL · Jun 20, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the effectiveness and safety of two blood-thinning medications, rivaroxaban and warfarin, for patients who have recently undergone surgery to replace or repair heart valves made of biological materials (bioprosthetic valves). The goal is to understand which medication works better and is safer during the early weeks after surgery.

To participate in this study, individuals should be between 18 and 80 years old and must have had successful surgery for a bioprosthetic valve. Participants will need to sign an agreement to join the trial and will be closely monitored throughout the study. It’s important to note that certain people will not be eligible, such as those with mechanical heart valves or specific health conditions that could increase their risk of bleeding. This trial is not yet recruiting participants, but it aims to help improve care for patients recovering from heart valve surgery.

Gender

ALL

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