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Trial record 14 of 412 for:    Recruiting, Not yet recruiting, Available Studies | "Heart Valve Diseases"

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

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ClinicalTrials.gov Identifier: NCT02303795
Recruitment Status : Recruiting
First Posted : December 1, 2014
Last Update Posted : December 16, 2016
Sponsor:
Information provided by (Responsible Party):
Hospital do Coracao

Brief Summary:
RIvaroxaban for Valvular heart diseasE and atRial fibrillation trial (RIVER trial).

Condition or disease Intervention/treatment Phase
Valvular Heart Disease Drug: Rivaroxaban Drug: Warfarin Phase 2

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 Bioprosthetic Mitral valves - RIVER.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Bioprosthetic Mitral Valves - RIVER
Study Start Date : August 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018


Arm Intervention/treatment
Active Comparator: Rivaroxaban 20mg
Oral Rivaroxaban, 20 mg od. Patients with a calculated creatinine clearance of 30 to 49 mL/min per 1.73 m2 received a reduced dose of rivaroxaban of 15 mg od.
Drug: Rivaroxaban
Patients assigned to rivaroxaban will receive oral rivaroxaban, 20 mg od. Patients with a calculated creatinine clearance of 30 to 49 mL/min per 1.73 m2 received a reduced dose of rivaroxaban of 15 mg od.

Drug: Warfarin

Patients will take the warfarin once daily (q.d.). The individual doses will be titrated as needed to maintain a target INR of 2.0-3.0.

Patients with 65 > years old, should take warfarin (2,5mg/day) and all others patients should take 5mg/day.


Active Comparator: Warfarin
Warfarin Warfarin once daily (q.d.). The individual doses will be titrated as needed to maintain a target INR of 2.0-3.0.
Drug: Rivaroxaban
Patients assigned to rivaroxaban will receive oral rivaroxaban, 20 mg od. Patients with a calculated creatinine clearance of 30 to 49 mL/min per 1.73 m2 received a reduced dose of rivaroxaban of 15 mg od.

Drug: Warfarin

Patients will take the warfarin once daily (q.d.). The individual doses will be titrated as needed to maintain a target INR of 2.0-3.0.

Patients with 65 > years old, should take warfarin (2,5mg/day) and all others patients should take 5mg/day.





Primary Outcome Measures :
  1. Major Clinical Events [ Time Frame: 12 months ]
    Combined Endpoint: disabling strokes, Major bleeding, all-cause death, valve thrombosis and non-CNS systemic embolism


Secondary Outcome Measures :
  1. Major bleeding [ Time Frame: 12 months ]
    Clinically overt bleeding associated with: fatal outcome, involving a critical site, or clinically overt bleeding associated with a fall in hemoglobin concentration of ≥2 g/dL, or leading to transfusion of ≥2 units of packed red blood cells or whole blood.

  2. Combined endpoint of nonfatal stroke, non-CNS systemic embolism, valve thrombosis, and vascular death [ Time Frame: 12 months ]

    Stroke: sudden, focal neurologic deficit from a presumed cerebrovascular cause, not reversible within 24 hours and not due to na identifiable cause.

    Non-CNS systemic embolism: abrupt vascular insufficiency associated with clinical or radiologic evidence of arterial occlusion.

    Valve thrombosis: any thrombus attached to or near an implanted valve that occludes part of the blood flow, interferes with function or warrant treatment.

    Mortality: Deaths any cause. Venous thromboembolism: verification by definitive diagnostic evaluation. Deep Vein Thrombosis: abnormal compression ultrasound or intraluminal filling defect on venography or autopsy.

    Pulmonary embolism: at least one: 1) intraluminal filling defect on CT scan; 2) intraluminal filling defect on pulmonary angiogram; 3) high- probability on v/p lung scan; 4)inconclusive spiral CT, pulmonary image with demonstration of DVT in the lower extremities; 5) autopsy




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female patients aged >18 and < 80 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02303795


Contacts
Contact: Otavio Berwanger, MD, PhD + 55 (11) 3053-6611 ext 8201 oberwanger@hcor.com.br
Contact: Hélio P Guimarães, MD, PhD + 55 (11) 3053-6611 ext 8210 heliopg@yahoo.com.br

Locations
Brazil
Associação do Sanatório Sírio - Hospital do Coração HCor Recruiting
São Paulo, SP, Brazil, 04004050
Contact: Hélio P Guimaraes, MD, PhD    +551130536611 ext 8235    heliopg@yahoo.com.br   
Contact: Leticia Kawano-Dourado, MD, PhD    +551130536611 ext 8209    ldourado@hcor.com.br   
Sponsors and Collaborators
Hospital do Coracao
Investigators
Study Chair: Otavio Berwanger, MD, PhD Hospital do Coracao
Study Chair: Ricardo Pavanello, MD, PhD Hospital do Coracao
Principal Investigator: Carlos C Magalhães, MD, PhD Hospital do Coracao

Responsible Party: Hospital do Coracao
ClinicalTrials.gov Identifier: NCT02303795     History of Changes
Other Study ID Numbers: RIVER01
First Posted: December 1, 2014    Key Record Dates
Last Update Posted: December 16, 2016
Last Verified: December 2016

Keywords provided by Hospital do Coracao:
bioprosthetic mitral valve
valvular heart disease
anticoagulant agents
NOACs
rivaroxaban
warfarin

Additional relevant MeSH terms:
Heart Valve Diseases
Atrial Fibrillation
Heart Diseases
Arrhythmias, Cardiac
Cardiovascular Diseases
Pathologic Processes
Warfarin
Rivaroxaban
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action