Anticoagulation
Conditions
Keywords
warfarin, rivaroxaban, Bioprosthetic valve, anticoagulation
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.
Interventions
DRUGRivaroxaban
To compare the efficacy and safety of rivaroxaban as an early anticoagulant therapy for BPV patients with the traditional postoperative anticoagulant warfarin
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| all-cause death | 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. |
| 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) | 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. |
| Major bleeding | 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
| Measure | Time frame | Description |
|---|---|---|
| Thromboembolic events (stroke, TIA, deep venous thrombosis, pulmonary embolism, non-CNS systemic embolism, valve thrombosis). | 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. |
| Cardiovascular causes death | 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. |
| Major bleeding events and clinically relevant non-major (CRNM) bleeding events and minor bleeding events | 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. |
Contacts
Primary ContactBo Xie
Backup ContactXin Wang
Outcome results
None listed