Status:
COMPLETED
RIvaroxaban for Valvular Heart diseasE and atRial Fibrillation Trial -RIVER Trial
Lead Sponsor:
Hospital do Coracao
Conditions:
Valvular Heart Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RIvaroxaban for Valvular heart diseasE and atRial fibrillation trial (RIVER trial).
Detailed Description
A Phase 2, Randomized, Open label, Non-Inferiority Clinical Trial to Explore the Safety and Efficacy of Rivaroxaban compared with vitamin K antagonism in Patients with Atrial Fibrillation with Biopros...
Eligibility Criteria
Inclusion
- Male and female patients aged \>18 years at time of inclusion
- Patients with Persistent or paroxysmal Atrial Fibrillation or flutter with bioprosthetic mitral valves.
- The patient must be able to give informed consent
Exclusion
- Cardiovascular-related conditions as known presence of cardiac thrombus or tumor
- Active endocarditis
- Uncontrolled hypertension
- Hemorrhage risk-related criteria
- Active internal bleeding
- History of, or condition associated with, increased bleeding risk
- Concomitant conditions and therapies
- History of previous thromboembolism with high risk of bleeding:
- Severe, disabling stroke (modified Rankin score of 4-5, inclusive) within 3 months
- Acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to randomization
- Acute MI within the last 14 days prior to randomization
- Treatment with: Chronic aspirin therapy \> 100 mg daily or dual antiplatelet therapy; Intravenous antiplatelets; Fibrinolytics; Anticipated need for long-term treatment with a nonsteroidal antiinflammatory drug; Systemic treatment with a strong inhibitor of cytochrome P450 3A4, such as ketoconazole or protease inhibitors; Treatment with a strong inducer of cytochrome P450 3A4, such as rifampicin, phenytoin, phenobarbital, or carbamazepine.
- Anemia
- Pregnancy or breastfeeding or women of reproductive age not using effective contraceptive methods
- Calculated creatinine clearance bellow 30 mL/min
- Known significant liver disease or alanine aminotransferase N3× the upper limit of normal
- Previous participation in this study.
Key Trial Info
Start Date :
August 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2020
Estimated Enrollment :
1005 Patients enrolled
Trial Details
Trial ID
NCT02303795
Start Date
August 1 2015
End Date
August 1 2020
Last Update
April 12 2022
Active Locations (1)
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1
Associação do Sanatório Sírio - Hospital do Coração HCor
São Paulo, São Paulo, Brazil, 04004050