A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction or Stroke in Participants With Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure

PHASE3CompletedINTERVENTIONAL
Enrollment

5,081

Participants

Timeline

Start Date

September 10, 2013

Primary Completion Date

April 19, 2018

Study Completion Date

April 19, 2018

Conditions
Heart FailureCoronary Artery Disease
Interventions
DRUG

Rivaroxaban

Each participant, randomly allocated to the rivaroxaban arm, will receive one 2.5 mg tablet of rivaroxaban orally (by mouth) twice daily (once in the morning and once in the evening at approximately the same time each day) until the global treatment end date (GTED) (defined as the date when 1200 primary efficacy outcome events have occurred). Rivaroxaban will be given with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).

DRUG

Placebo

Each participant, randomly allocated to the placebo arm, will receive one matching placebo tablet orally twice daily (once in the morning and once in the evening at approximately the same time each day) until the GTED. Placebo will be given with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).

OTHER

Standard of care for heart failure and coronary artery disease

Each participant's standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician) should be continued throughout the study.

Trial Locations (563)

Unknown

Niigata

Okayama

Okinawa

Osaka

Ōita

Saga

Saitama

Sapporo

Sendai

Shiga

Shimane

Shizuoka

Tachikawa

Takaraduka

Tochigi

Tokushima

Tokyo

Toyama

Toyoake

Tsu

Wakayama

Yamaguchi

Yatsushiro

Yokohama

Yonago

Daugavpils

Kuldīga

Liepāja

Riga

Sigulda

Ventspils

Alytus

Kaunas

Klaipėda

Panevezys

Šiauliai

Vilnius

Cheras

George Town

Johor Bahru

Kota Kinabalu

Kuala Lumpur

Kuala Selangor

Kuching

Selayang Baru Utara

Aguascalientes

Benito Juárez

Chihuahua City

Culiacán

Durango

Guadalajara

León

Mexico City

México

Oaxaca City

Pachuca

Puebla City

Querétaro

San Luis Potosí City

Tampico

Veracruz

Almere Stad

Amsterdam

Blaricum

Breda

Deventer

Doetinchem

Ede

Groningen

Heerlen

Helmond

Maastricht

Meppel

Tilburg

Będzin

Gdynia

Gliwice

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Inowrocław

Katowice

Kielce

Krakow

Kutno

Lodz

Lubin

Lublin

Myślenice

Olsztyn

Ostrowiec Świętokrzyski

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Oświęcim

Puławy

Płock

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Skierniewice

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Szczecin

Torun

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Wroclaw

Włocławek

Zabrze

Zamość

Łódż

Almada

Aveiro

Braga

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Covilha

Leiria

Lisbon

Matosinhos Municipality

Viana do Castelo

Vila Real

Bacau

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Brasov

Brăila

Bucharest

Buzău

Cluj-Napoca

Craiova

Focşani

Galati

Iași

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Piteşti

Sibiu

Târgu Mureş

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Perm

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Samara

Saratov

Syktyvkar

Tomsk

Tyumen

Voronezh

Yaroslavl

Yekaterinburg

Banská Bystrica

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Košice

Lučenec

Moldava nad Bodvou

Nitra

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Svidník

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TA1 5DA

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Praha 8 - Libe?

Slaný

Teplice

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Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

Janssen Research & Development, LLC

INDUSTRY