NCT02303795

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,005

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2015

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 1, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

5 years

First QC Date

November 19, 2014

Last Update Submit

April 4, 2022

Conditions

Valvular Heart Disease

Keywords

bioprosthetic mitral valvevalvular heart diseaseanticoagulant agentsNOACsrivaroxabanwarfarin

Outcome Measures

Primary Outcomes (1)

  • Major Clinical Events

    Combined Endpoint of major clinical events as defined by strokes (CVA), transient ischemic attack (TIA), major bleeding, all-cause death, valve thrombosis and non-CNS systemic embolism, hospitalization due to cardiac failure.

    12 months

Secondary Outcomes (2)

  • Major bleeding

    12 months

  • Combined endpoint of nonfatal stroke (CVA), transient ischemic attack (TIA), systemic embolism, valve thrombosis, venous thromboembolism and vascular causes death.thrombosis, and vascular death

    12 months

Study Arms (2)

Rivaroxaban 20mg

ACTIVE COMPARATOR

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: RivaroxabanDrug: Warfarin

Warfarin

ACTIVE COMPARATOR

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: RivaroxabanDrug: Warfarin

Interventions

RivaroxabanDRUG

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.

Rivaroxaban 20mgWarfarin
WarfarinDRUG

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.

Rivaroxaban 20mgWarfarin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Persistent or paroxysmal Atrial Fibrillation or flutter with bioprosthetic mitral valves.
  • The patient must be able to give informed consent

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Associação do Sanatório Sírio - Hospital do Coração HCor

São Paulo, São Paulo, 04004050, Brazil

Location

Related Publications (2)

  • Guimaraes HP, Lopes RD, de Barros E Silva PGM, Liporace IL, Sampaio RO, Tarasoutchi F, Hoffmann-Filho CR, de Lemos Soares Patriota R, Leiria TLL, Lamprea D, Precoma DB, Atik FA, Silveira FS, Farias FR, Barreto DO, Almeida AP, Zilli AC, de Souza Neto JD, Cavalcante MA, Figueira FAMS, Kojima FCS, Damiani L, Santos RHN, Valeis N, Campos VB, Saraiva JFK, Fonseca FH, Pinto IM, Magalhaes CC, Ferreira JFM, Alexander JH, Pavanello R, Cavalcanti AB, Berwanger O; RIVER Trial Investigators. Rivaroxaban in Patients with Atrial Fibrillation and a Bioprosthetic Mitral Valve. N Engl J Med. 2020 Nov 26;383(22):2117-2126. doi: 10.1056/NEJMoa2029603. Epub 2020 Nov 14.

    PMID: 33196155DERIVED

  • Guimaraes HP, de Barros E Silva PGM, Liporace IL, Sampaio RO, Tarasoutchi F, Paixao M, Hoffmann-Filho CR, Patriota R, Leiria TLL, Lamprea D, Precoma DB, Atik FA, Silveira FS, Farias FR, Barreto DO, Almeida AP, Zilli AC, de Souza Neto JD, Cavalcante MA, Figueira FAMS, Junior RA, Moises VA, Mesas CE, Ardito RV, Kalil PSA, Paiva MSMO, Maldonado JGA, de Lima CEB, D'Oliveira Vieira R, Laranjeira L, Kojima F, Damiani L, Nakagawa RH, Dos Santos JRY, Sampaio BS, Campos VB, Saraiva JFK, Fonseca FH, Pinto IM, Magalhaes CC, Ferreira JFM, Lopes RD, Pavanello R, Cavalcanti AB, Berwanger O; RIVER (RIvaroxaban for Valvular Heart diseasE and atRial Fibrillation Trial -RIVER Trial) Investigators. A randomized clinical trial to evaluate the efficacy and safety of rivaroxaban in patients with bioprosthetic mitral valve and atrial fibrillation or flutter: Rationale and design of the RIVER trial. Am Heart J. 2021 Jan;231:128-136. doi: 10.1016/j.ahj.2020.10.001. Epub 2020 Oct 10.

    PMID: 33045224DERIVED

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

RivaroxabanWarfarin

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Otavio Berwanger, MD, PhD

    Hospital do Coracao

    STUDY CHAIR

  • Ricardo Pavanello, MD, PhD

    Hospital do Coracao

    STUDY CHAIR

  • Helio P Guimarães, MD, PhD

    Hospital do Coracao

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2014

First Posted

December 1, 2014

Study Start

August 1, 2015

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

April 12, 2022

Record last verified: 2022-04

Locations

BR(1)