Overview

RIvaroxaban for Valvular Heart diseasE and atRial Fibrillation Trial -RIVER Trial

Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
0
Participant gender:
All
Summary
RIvaroxaban for Valvular heart diseasE and atRial fibrillation trial (RIVER trial).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hospital do Coracao
Treatments:
Rivaroxaban
Warfarin
Criteria
Inclusion Criteria:

1. Male and female patients aged >18 years at time of inclusion

2. Patients with Persistent or paroxysmal Atrial Fibrillation or flutter with
bioprosthetic mitral valves.

- The patient must be able to give informed consent

Exclusion Criteria:

1. Cardiovascular-related conditions as known presence of cardiac thrombus or tumor

- Active endocarditis

- Uncontrolled hypertension

2. Hemorrhage risk-related criteria

- Active internal bleeding

- History of, or condition associated with, increased bleeding risk

3. 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.