AzTrials
AzTrials

Heart FailurePhase 3COMMANDER HFNCT01877915

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

A Phase 3 study testing Rivaroxaban in people with Heart Failure and Coronary Artery Disease, run by Janssen Research & Development, LLC at 562 sites in 32 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to assess the effectiveness and safety of rivaroxaban compared with placebo (inactive medication), in reducing the risk of death, myocardial infarction or stroke in participants with heart failure and significant coronary artery disease following an episode of decompensated heart failure. Read more about this study

Who is it for?
Ages 18 to 95 years
Conditions the study is for
Heart Failure, Coronary Artery Disease
What is being tested?
Rivaroxaban
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
5,081 participants
Where
562 sitesin 32 countries
Study dates
10 Sep 2013to 19 Apr 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must have symptomatic heart failure for at least 3 months prior to Screening
  • Participants must have an episode of decompensated heart failure (index event) requiring (a) an overnight stay [that is, staying past midnight] in a hospital, emergency department, or medical facility with the capability of treating with intravenous medications and observing heart failure patients before randomization or (b) an unscheduled outpatient visit to a heart failure management center, where parenteral therapy is required for heart failure stabilization. An episode of decompensated heart failure is defined as symptoms of worsening dyspnea or fatigue, objective signs of congestion such as peripheral edema or ascites, and/or adjustment of pre-hospitalization/outpatient visit heart failure medications. Participants are eligible for randomization at discharge from the facility treating the index event and up to 30 days after discharge if they are in stable condition
  • Must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40 percent (%) within 1 year before randomization
  • Must have evidence of significant coronary artery disease
  • Must be medically stable in terms of their heart failure clinical status at the time of randomization
  • Must have a brain natriuretic peptide (BNP) level greater than or equal to (>=) 200 picogram per milliliter (pg/mL) or N-terminal-proBNP (NT-proBNP) level >=800 pg/mL (preferred assay) during the Screening period and before randomization

Who cannot join

  • Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding, such as, but not limited to, active internal bleeding, clinically significant bleeding, bleeding at a noncompressible site, or bleeding diathesis within 28 days of randomization
  • Severe concomitant disease such as (a) atrial fibrillation (AFib) or another condition that requires chronic anticoagulation (participants with isolated transient AFib may be allowed at the discretion of the treating physician investigator) and (b) Documented acute myocardial infarction (MI) during index event
  • Prior stroke within 90 days of randomization
  • Has been hospitalized for longer than 21 days during the index event
  • Planned intermittent outpatient treatment with positive inotropic drugs administered intravenously

Trial locations and contacts

562 sites in 32 countries.

562 sites in 32 countries

United States115 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Alexander City, Alabama

  • Study site

    Anchorage, Alaska

  • Study site

    Anderson, Indiana

  • Study site

    Athens, Georgia

  • Study site

    Atlanta, Georgia

  • Study site

    Atlantis, Florida

  • Study site

    Aurora, Colorado

  • Study site

    Baltimore, Maryland

  • Study site

    Bartlesville, Oklahoma

  • Study site

    Bay City, Michigan

  • Study site

    Bellingham, Washington

  • Study site

    Beverly Hills, California

  • Study site

    Biddeford, Maine

  • Study site

    Birmingham, Alabama

  • Study site

    Bossier City, Louisiana

  • Study site

    Bridgewater, New Jersey

  • Study site

    Buffalo, New York

  • Study site

    Burlington, Vermont

  • Study site

    Canton, Ohio

  • Study site

    Charleston, South Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Chula Vista, California

  • Study site

    Cincinnati, Ohio

  • Study site

    Columbia, Maryland

  • Study site

    Columbus, Ohio

  • Study site

    Cortlandt Manor, New York

  • Study site

    Cumming, Georgia

  • Study site

    Cypress, Texas

  • Study site

    Dallas, Texas

  • Study site

    Dayton, Ohio

  • Study site

    Daytona Beach, Florida

  • Study site

    Denver, Colorado

  • Study site

    Doylestown, Pennsylvania

  • Study site

    El Cajon, California

  • Study site

    Elizabethtown, Kentucky

  • Study site

    Elmer, New Jersey

  • Study site

    Evanston, Illinois

  • Study site

    Fairfield, Ohio

  • Study site

    Fairview Heights, Illinois

  • Study site

    Fort Worth, Texas

  • Study site

    Glendale, California

  • Study site

    Grand Blanc, Michigan

  • Study site

    Haddon Heights, New Jersey

  • Study site

    Hammond, Louisiana

  • Study site

    High Point, North Carolina

  • Study site

    Houston, Texas

  • Study site

    Huntington, West Virginia

  • Study site

    Huntsville, Texas

  • Study site

    Indianapolis, Indiana

  • Study site

    Iowa City, Iowa

  • Study site

    Jamaica, New York

  • Study site

    Jonesboro, Arkansas

  • Study site

    Jupiter, Florida

  • Study site

    Kettering, Ohio

  • Study site

    Kingwood, Texas

  • Study site

    La Mesa, California

  • Study site

    Las Vegas, Nevada

  • Study site

    Lexington, Kentucky

  • Study site

    Lincoln, Nebraska

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Lubbock, Texas

  • Study site

    Macon, Georgia

  • Study site

    Manalapan, New Jersey

  • Study site

    McKinney, Texas

  • Study site

    Merrillville, Indiana

  • Study site

    Mineola, New York

  • Study site

    Mobile, Alabama

  • Study site

    Mount Clemens, Michigan

  • Study site

    Munster, Indiana

  • Study site

    Nashville, Tennessee

  • Study site

    New Haven, Connecticut

  • Study site

    New York, New York

  • Study site

    Newport Beach, California

  • Study site

    Newport News, Virginia

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Orange, California

  • Study site

    Orlando, Florida

  • Study site

    Owensboro, Kentucky

  • Study site

    Peoria, Illinois

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pinehurst, North Carolina

  • Study site

    Pontiac, Michigan

  • Study site

    Portland, Oregon

  • Study site

    Randallstown, Maryland

  • Study site

    Ridgewood, New Jersey

  • Study site

    Rockford, Illinois

  • Study site

    Saint Paul, Minnesota

  • Study site

    Sayre, Pennsylvania

  • Study site

    Sellersville, Pennsylvania

  • Study site

    Sewell, New Jersey

  • Study site

    Shreveport, Louisiana

  • Study site

    Sioux Falls, South Dakota

  • Study site

    Slidell, Louisiana

  • Study site

    South Bend, Indiana

  • Study site

    Springfield, Missouri

  • Study site

    St Louis, Missouri

  • Study site

    St. Petersburg, Florida

  • Study site

    Stockton, California

  • Study site

    Tacoma, Washington

  • Study site

    Tallahassee, Florida

  • Study site

    Torrance, California

  • Study site

    Tucker, Georgia

  • Study site

    Tucson, Arizona

  • Study site

    Tulsa, Oklahoma

  • Study site

    Urbana, Illinois

  • Study site

    Washington, Missouri

  • Study site

    Wellington, Florida

  • Study site

    Winter Haven, Florida

  • Study site

    Wynnewood, Pennsylvania

  • Study site

    Yardley, Pennsylvania

  • Study site

    York, Pennsylvania

  • Study site

    Ypsilanti, Michigan

Other trials in United States

Japan51 sites

  • Study site

    Aichi

  • Study site

    Chiba

  • Study site

    Chikushino-shi

  • Study site

    Ehime

  • Study site

    Fukuoka

  • Study site

    Gifu

  • Study site

    Gunma

  • Study site

    Hatsukaichi

  • Study site

    Hitachi

  • Study site

    Hokkaido

  • Study site

    Hyōgo

  • Study site

    Ibaraki

  • Study site

    Ishikawa

  • Study site

    Izumo

  • Study site

    Kagawa

  • Study site

    Kahoku-District

  • Study site

    Kanagawa

  • Study site

    Kobe

  • Study site

    Komatsushima-shi

  • Study site

    Koshigaya-shi

  • Study site

    Kumamoto

  • Study site

    Kyoto

  • Study site

    Miyazaki

  • Study site

    Nagano

  • Study site

    Nagasaki

  • Study site

    Nagoya

  • Study site

    Niigata

  • Study site

    Ōita

  • Study site

    Okayama

  • Study site

    Okinawa

  • Study site

    Osaka

  • Study site

    Saga

  • Study site

    Saitama

  • Study site

    Sapporo

  • Study site

    Sendai

  • Study site

    Shiga

  • Study site

    Shimane

  • Study site

    Shizuoka

  • Study site

    Tachikawa

  • Study site

    Takaraduka

  • Study site

    Tochigi

  • Study site

    Tokushima

  • Study site

    Tokyo

  • Study site

    Toyama

  • Study site

    Toyoake

  • Study site

    Tsu

  • Study site

    Wakayama

  • Study site

    Yamaguchi

  • Study site

    Yatsushiro

  • Study site

    Yokohama

  • Study site

    Yonago

Other trials in Japan

Poland30 sites

  • Study site

    Będzin

  • Study site

    Gdynia

  • Study site

    Gliwice

  • Study site

    Grodzisk Mazowiecki

  • Study site

    Inowrocław

  • Study site

    Katowice

  • Study site

    Kielce

  • Study site

    Krakow

  • Study site

    Kutno

  • Study site

    Lodz

  • Study site

    Łódż

  • Study site

    Lubin

  • Study site

    Lublin

  • Study site

    Myślenice

  • Study site

    Olsztyn

  • Study site

    Ostrołęka

  • Study site

    Ostrowiec Świętokrzyski

  • Study site

    Oświęcim

  • Study site

    Płock

  • Study site

    Puławy

  • Study site

    Rabka-Zdrój

  • Study site

    Skierniewice

  • Study site

    Starogard Gdański

  • Study site

    Szczecin

  • Study site

    Torun

  • Study site

    Warsaw

  • Study site

    Włocławek

  • Study site

    Wroclaw

  • Study site

    Zabrze

  • Study site

    Zamość

Other trials in Poland

China27 sites

  • Study site

    Baotou

  • Study site

    Beijing

  • Study site

    Changchun

  • Study site

    Changsha

  • Study site

    Chengdu

  • Study site

    Daqing

  • Study site

    Guangzhou

  • Study site

    Haikou

  • Study site

    Hangzhou

  • Study site

    Hunan

  • Study site

    Jinan

  • Study site

    Jining

  • Study site

    Lanzhou

  • Study site

    Nanchang

  • Study site

    Nanjing

  • Study site

    Nanning

  • Study site

    Qingdao

  • Study site

    Shanghai

  • Study site

    Shenyang

  • Study site

    Shijiazhuang

  • Study site

    Suzhou

  • Study site

    Taiyuan

  • Study site

    Tianjin

  • Study site

    Wuhan

  • Study site

    Xi'an

  • Study site

    Yangzhou

  • Study site

    Yichang

Other trials in China

Russia27 sites

  • Study site

    Arkhangelsk

  • Study site

    Barnaul

  • Study site

    Chita

  • Study site

    Ivanovo

  • Study site

    Izhevsk

  • Study site

    Kaluga

  • Study site

    Kemerovo

  • Study site

    Kirov

  • Study site

    Krasnoyarsk

  • Study site

    Kursk

  • Study site

    Moscow

  • Study site

    Moscow, Zelenograd

  • Study site

    Nizhny Novgorod

  • Study site

    Novosibirsk

  • Study site

    Orenburg

  • Study site

    Perm

  • Study site

    Rostov-on-Don

  • Study site

    Ryazan

  • Study site

    Saint Petersburg

  • Study site

    Samara

  • Study site

    Saratov

  • Study site

    Syktyvkar

  • Study site

    Tomsk

  • Study site

    Tyumen

  • Study site

    Voronezh

  • Study site

    Yaroslavl

  • Study site

    Yekaterinburg

Other trials in Russia

Spain26 sites

  • Study site

    A Coruña

  • Study site

    Alicante

  • Study site

    Almería

  • Study site

    Ávila

  • Study site

    Barcelona

  • Study site

    Burgos

  • Study site

    Cáceres

  • Study site

    Elche

  • Study site

    Granada

  • Study site

    Lorca

  • Study site

    Madrid

  • Study site

    Majadahonda

  • Study site

    Murcia

  • Study site

    Olot

  • Study site

    Orihuela

  • Study site

    Palma de Mallorca

  • Study site

    San Juan

  • Study site

    Sanlúcar de Barrameda

  • Study site

    Sant Joan Despí

  • Study site

    Santander

  • Study site

    Seville

  • Study site

    Terrassa

  • Study site

    Torrevieja

  • Study site

    Valencia

  • Study site

    Vigo

  • Study site

    Viladecans

Other trials in Spain

Brazil23 sites

  • Study site

    Belém

  • Study site

    Belo Horizonte

  • Study site

    Blumenal

  • Study site

    Brasília

  • Study site

    Campina Grande do Sul

  • Study site

    Campinas

  • Study site

    Campo Grande

  • Study site

    Canoas

  • Study site

    Curitiba

  • Study site

    Goiânia

  • Study site

    Marília

  • Study site

    Passo Fundo

  • Study site

    Porto Alegre

  • Study site

    Recife

  • Study site

    Ribeirão Preto

  • Study site

    Rio de Janeiro

  • Study site

    Salvador

  • Study site

    São Jose Do Rio Preto

  • Study site

    São Paulo

  • Study site

    São Pedro

  • Study site

    Tatuí

  • Study site

    Uberlândia

  • Study site

    Votuporanga

Other trials in Brazil

Germany19 sites

  • Study site

    Berlin

  • Study site

    Bielefeld

  • Study site

    Bonn

  • Study site

    Coburg

  • Study site

    Dresden

  • Study site

    Halle

  • Study site

    Hamburg

  • Study site

    Heidelberg

  • Study site

    Konstanz

  • Study site

    Langen

  • Study site

    Leipzig

  • Study site

    Ludwigshafen

  • Study site

    Magdeburg

  • Study site

    Mainz

  • Study site

    Markkleeberg

  • Study site

    Papenburg

  • Study site

    Stuttgart

  • Study site

    Ulm

  • Study site

    Witten

Other trials in Germany

Czechia17 sites

  • Study site

    Brno

  • Study site

    Hodonín

  • Study site

    Hradec Králové

  • Study site

    Hranice

  • Study site

    Karlovy Vary

  • Study site

    Kladno

  • Study site

    Kolín

  • Study site

    Litomyšl

  • Study site

    Mladá Boleslav

  • Study site

    Olomouc

  • Study site

    Plze?-Bory

  • Study site

    Prague

  • Study site

    Praha 8 - Libe?

  • Study site

    Slaný

  • Study site

    Teplice

  • Study site

    Uherské Hradišt?

  • Study site

    Valašské Mezi?í?í

Other trials in Czechia

Argentina16 sites

  • Study site

    Bahía Blanca

  • Study site

    Buenos Aires

  • Study site

    Caba

  • Study site

    Córdoba

  • Study site

    La Plata

  • Study site

    Mar del Plata

  • Study site

    Mendoza

  • Study site

    Merlo

  • Study site

    Quilmes

  • Study site

    Resistencia

  • Study site

    Rosario

  • Study site

    San Miguel de Tucumán

  • Study site

    San Nicolás

  • Study site

    Santa Fe

  • Study site

    Santiago del Estero

  • Study site

    Vicente López

Other trials in Argentina

Mexico16 sites

  • Study site

    Aguascalientes

  • Study site

    Benito Juárez

  • Study site

    Chihuahua City

  • Study site

    Culiacán

  • Study site

    Durango

  • Study site

    Guadalajara

  • Study site

    León

  • Study site

    México

  • Study site

    Mexico City

  • Study site

    Oaxaca City

  • Study site

    Pachuca

  • Study site

    Puebla City

  • Study site

    Querétaro

  • Study site

    San Luis Potosí City

  • Study site

    Tampico

  • Study site

    Veracruz

Other trials in Mexico

Romania16 sites

  • Study site

    Bacau

  • Study site

    Baia Mare

  • Study site

    Brăila

  • Study site

    Brasov

  • Study site

    Bucharest

  • Study site

    Buzău

  • Study site

    Cluj-Napoca

  • Study site

    Craiova

  • Study site

    Focşani

  • Study site

    Galati

  • Study site

    Iași

  • Study site

    Oradea

  • Study site

    Piteşti

  • Study site

    Sibiu

  • Study site

    Târgu Mureş

  • Study site

    Timișoara

Other trials in Romania

Ukraine15 sites

  • Study site

    Cherkassy

  • Study site

    Cherkasy

  • Study site

    Dnipro

  • Study site

    Donetsk

  • Study site

    Kharkiv

  • Study site

    Kyiv

  • Study site

    Lutsk

  • Study site

    Lviv

  • Study site

    Odesa

  • Study site

    Poltava

  • Study site

    Sumy

  • Study site

    Vinnitsa

  • Study site

    Vinnytsia

  • Study site

    Zaporizhzhya

  • Study site

    Zhytomyr

Other trials in Ukraine

United Kingdom15 sites

  • Study site

    Aberdeen

  • Study site

    Airdrie

  • Study site

    Birmingham

  • Study site

    Chesterfield

  • Study site

    Chichester

  • Study site

    Clydebank

  • Study site

    Cottingham

  • Study site

    Dudley

  • Study site

    Dundee

  • Study site

    East Kilbride

  • Study site

    Exeter

  • Study site

    Inverness

  • Study site

    Manchester

  • Study site

    Metropolitan Borough of Wirral

  • Study site

    TA1 5DA

Other trials in United Kingdom

Netherlands13 sites

  • Study site

    Almere Stad

  • Study site

    Amsterdam

  • Study site

    Blaricum

  • Study site

    Breda

  • Study site

    Deventer

  • Study site

    Doetinchem

  • Study site

    Ede

  • Study site

    Groningen

  • Study site

    Heerlen

  • Study site

    Helmond

  • Study site

    Maastricht

  • Study site

    Meppel

  • Study site

    Tilburg

Other trials in Netherlands

Bulgaria12 sites

  • Study site

    Blagoevgrad

  • Study site

    Burgas

  • Study site

    Dimitrovgrad

  • Study site

    Kazanlak

  • Study site

    Pazardzhik

  • Study site

    Pleven

  • Study site

    Plovdiv

  • Study site

    Rousse

  • Study site

    Sofia

  • Study site

    Stara Zagora

  • Study site

    Varna

  • Study site

    Veliko Tarnovo

Other trials in Bulgaria

France12 sites

  • Study site

    Besançon

  • Study site

    Bron

  • Study site

    Chambray-lès-Tours

  • Study site

    Corbeil-Essonnes

  • Study site

    Lille

  • Study site

    Montpellier

  • Study site

    Nantes

  • Study site

    Nice

  • Study site

    Pau

  • Study site

    Rouen

  • Study site

    Toulouse

  • Study site

    Vandœuvre-lès-Nancy

Other trials in France

Canada11 sites

  • Study site

    Cambridge, Ontario

  • Study site

    Edmonton, Alberta

  • Study site

    Halifax, Nova Scotia

  • Study site

    Kitchener, Ontario

  • Study site

    London, Ontario

  • Study site

    Maple Ridge, British Columbia

  • Study site

    Montreal, Quebec

  • Study site

    Ottawa, Ontario

  • Study site

    Scarborough Village, Ontario

  • Study site

    St. John's, Newfoundland and Labrador

  • Study site

    Toronto, Ontario

Other trials in Canada

Portugal11 sites

  • Study site

    Almada

  • Study site

    Aveiro

  • Study site

    Braga

  • Study site

    Carnaxide

  • Study site

    Coimbra

  • Study site

    Covilha

  • Study site

    Leiria

  • Study site

    Lisbon

  • Study site

    Matosinhos Municipality

  • Study site

    Viana do Castelo

  • Study site

    Vila Real

Other trials in Portugal

Turkey (Türkiye)11 sites

  • Study site

    Ankara

  • Study site

    Bursa

  • Study site

    Diyarbakır

  • Study site

    Eskişehir

  • Study site

    Istanbul

  • Study site

    Kahramanmaraş

  • Study site

    Kirikkale

  • Study site

    Kocaeli

  • Study site

    Konya

  • Study site

    Mersin

  • Study site

    Sivas

Other trials in Turkey (Türkiye)

Australia10 sites

  • Study site

    Bedford

  • Study site

    Cairns

  • Study site

    Concord

  • Study site

    Darlinghurst

  • Study site

    Hobart

  • Study site

    Launceston

  • Study site

    Perth

  • Study site

    Sydney

  • Study site

    Wollongong

  • Study site

    Woolloongabba

Other trials in Australia

Hungary10 sites

  • Study site

    Balatonfüred

  • Study site

    Berettyóújfalu

  • Study site

    Budapest

  • Study site

    Győr

  • Study site

    Miskolc

  • Study site

    Nagykanizsa

  • Study site

    Székesfehérvár

  • Study site

    Szekszárd

  • Study site

    Szolnok

  • Study site

    Zalaegerszeg

Other trials in Hungary

Malaysia8 sites

  • Study site

    Cheras

  • Study site

    George Town

  • Study site

    Johor Bahru

  • Study site

    Kota Kinabalu

  • Study site

    Kuala Lumpur

  • Study site

    Kuala Selangor

  • Study site

    Kuching

  • Study site

    Selayang Baru Utara

Other trials in Malaysia

Slovakia8 sites

  • Study site

    Banská Bystrica

  • Study site

    Bardejov

  • Study site

    Košice

  • Study site

    Lučenec

  • Study site

    Moldava nad Bodvou

  • Study site

    Nitra

  • Study site

    Považská Bystrica

  • Study site

    Svidník

Other trials in Slovakia

South Korea8 sites

  • Study site

    Busan

  • Study site

    Cheongju-si

  • Study site

    Daegu

  • Study site

    Daejeon

  • Study site

    Gwangju

  • Study site

    Seongnam-si

  • Study site

    Seoul

  • Study site

    Wŏnju

Other trials in South Korea

South Africa7 sites

  • Study site

    Bloemfontein

  • Study site

    Cape Town

  • Study site

    Centurion

  • Study site

    Durban

  • Study site

    Pinelands

  • Study site

    Pretoria

  • Study site

    Tongaat

Other trials in South Africa

Latvia6 sites

  • Study site

    Daugavpils

  • Study site

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    Køge

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    Voula

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    Uppsala

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About this study

Official title: A Randomized, Double-blind, Event-driven, Multicenter Study Comparing the Efficacy and Safety of Rivaroxaban With Placebo for Reducing the Risk of Death, Myocardial Infarction or Stroke in Subjects With Heart Failure and Significant Coronary Artery Disease Following an Episode of Decompensated Heart Failure

The purpose of this study is to assess the effectiveness and safety of rivaroxaban compared with placebo (inactive medication), in reducing the risk of death, myocardial infarction or stroke in participants with heart failure and significant coronary artery disease following an episode of decompensated heart failure.

Read the detailed description

This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), parallel group (each participant group receives different treatments simultaneously), event driven (the study duration is determined by the time taken for a specific number of events to occur), multicenter study to assess the effectiveness and safety of rivaroxaban compared with placebo, in reducing the risk of death, myocardial infarction or stroke in participants with heart failure and significant coronary artery disease following an episode of decompensated heart failure. Participants will be randomly assigned in a 1:1 ratio to receive either rivaroxaban or placebo (each in addition to standard of care for heart failure and coronary artery disease as prescribed by their managing physician). The study will consist of a screening phase, a double-blind treatment phase, and a follow-up after the sponsor-announced global treatment end date (GTED, defined as the date when 1200 primary efficacy outcome events are predicted to have occurred). The double-blind treatment phase is estimated to last for 6 to 54 months. Participants will discontinue study drug after taking both their morning and evening doses on the GTED and will return to the study center for the end-of-study visit (between 15 and 45 days but no sooner than 15 days after the GTED). Patient safety will be monitored throughout the study. The average study duration for participants is expected to be approximately 29 months. The study drug, rivaroxaban, is approved in the United States and in multiple countries around the world for the prevention and treatment of a number of thrombosis-mediated conditions.

Being tested
Rivaroxaban, Placebo, Standard of care for heart failure and coronary artery disease
Keywords
Heart Failure, Coronary Artery Disease, Stroke, Myocardial Infarction, Anticoagulation
Medical subject headings
Heart Failure, Coronary Artery Disease, Stroke, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RivaroxabanDrug

    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).

  • PlaceboDrug

    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).

  • Standard of care for heart failure and coronary artery diseaseOther

    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.

Study groups in NCT01877915
Study groupRoleWhat they receive
Rivaroxaban 2.5 mgExperimentalEach participant will receive 2.5 mg of rivaroxaban twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
Receives: Drug: Rivaroxaban; Other: Standard of care for heart failure and coronary artery disease
PlaceboPlacebo comparatorEach participant will receive matching placebo twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
Receives: Drug: Placebo; Other: Standard of care for heart failure and coronary artery disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event Rate of All-Cause Mortality, Myocardial Infarction (MI), or Stroke

    Event Rate of all-cause mortality (ACM), MI, or stroke were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 patient [pt]-year [yr]) = 100*n/(total risk exposure), where n is the number of events.

    Measured: Up to Global treatment end date (approximately 54 months)

  2. Event Rate of Either Fatal Bleeding or Bleeding Into a Critical Space With Potential for Permanent Disability

    Event rate of either fatal bleeding or bleeding into critical space with potential for permanent disability were assessed. Fatal bleeding event was death within 7 days after a bleeding event which required hospitalization or met International Society on Thrombosis and Haemostasis(ISTH) major bleeding definition criteria. Fatal bleeding events included those met criteria in 3 categories: 1: Any ISTH major bleeding event consider primary cause of death by investigator; 2: Any ISTH major bleeding event not considered to be primary cause of death by investigator but resulted in death within 7 days;3: Any bleeding event resulted in hospital stay and death within 7 days. Bleeding into critical space with potential for permanent disability included 7 critical spaces: intracranial, intraspinal, intraocular. Event rate estimated based on time to first occurrence of event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.

    Measured: Up to 227 Weeks

Secondary outcomes (7)

  1. Event Rate of Cardio Vascular Death or Re-Hospitalization for Worsening of Heart Failure (RHHF)

    Event rate of cardio vascular (CV) death or re-hospitalization for worsening of heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.

    Measured: Up to Global treatment end date (approximately 54 months)

  2. Event Rate of Cardio Vascular Death

    Event rate of cardio vascular death were assessed. CV death included deaths due to spontaneous bleeding, MI, stroke, worsening HF and arrhythmias, death due to CV procedures and sudden death. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.

    Measured: Up to Global treatment end date (approximately 54 months)

  3. Event Rate of Re-Hospitalization for Worsening of Heart Failure

    Event rate of re-hospitalization for worsening of heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.

    Measured: Up to Global treatment end date (approximately 54 months)

  4. Event Rate of Re-Hospitalization for Cardio Vascular Events (RHCV)

    Event rate due to cardio vascular events were assessed. Hospitalization for a CV Event required that participants be hospitalized (in-patient or emergency department) for greater than 24 hours and must have met the following criterion:Discharge summary with primary reason for admission listed as CV in nature (example, bleeding, arrhythmia, ACS, MI) other than HF which was captured in the HF re-hospitalization. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.

    Measured: Up to Global treatment end date (approximately 54 months)

  5. Event Rate of All-Cause Mortality (ACM) or Re-Hospitalization for Worsening Heart Failure

    Event rate of all-Cause Mortality (ACM) or re-Hospitalization for worsening heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.

    Measured: Up to Global treatment end date (approximately 54 months)

  6. Event Rate of Bleeding Events That Requiring Hospitalization

    Event rate of bleeding events and required Hospitalization were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.

    Measured: Up to 227 Weeks

  7. Event Rate of International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding Event

    Event rate of ISTH major bleeding event were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.

    Measured: Up to 227 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2013 (estimated)
  2. Study start10 Sep 2013
  3. Primary completion19 Apr 2018
  4. Study completion19 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
5,081 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01877915
Sponsor's protocol ID
CR101940
Other IDs
RIVAROXHFA3001, 2013-000046-19
Acronym
COMMANDER HF
Status last verified
Apr 2019
First submitted
12 Jun 2013
Last updated
10 May 2019
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Sharma A, Caldeira D, Razaghizad A, Pinto FJ, van Veldhuisen DJ, Mehra MR, Lam CSP, Cleland J, Anker SD, Greenberg B, Ferreira JP, Zannad F. Cardiovascular effects of rivaroxaban in heart failure patients with sinus rhythm and coronary disease with and without diabetes: a retrospective international cohort study from COMMANDER-HF. BMJ Open. 2023 Aug 11;13(8):e068865. doi: 10.1136/bmjopen-2022-068865.

    PubMed 37567750

  • Ferreira JP, Cleland JG, Lam CSP, Anker SD, Mehra MR, van Veldhuisen DJ, Byra WM, La Police DA, Pitt B, Greenberg B, Zannad F. Heart failure re-hospitalizations and subsequent fatal events in coronary artery disease: insights from COMMANDER-HF, EPHESUS, and EXAMINE. Clin Res Cardiol. 2021 Oct;110(10):1554-1563. doi: 10.1007/s00392-021-01830-1. Epub 2021 Mar 8.

    PubMed 33686472

  • Ferreira JP, Cleland JGF, Lam CSP, van Veldhuisen DJ, Byra WM, La Police DA, Anker SD, Mehra MR, Leroy C, Eschwege V, Toussaint-Hacquard M, Rossignol P, Greenberg B, Zannad F. Impact of Geographic Region on the COMMANDER-HF Trial. JACC Heart Fail. 2021 Mar;9(3):201-211. doi: 10.1016/j.jchf.2020.11.007. Epub 2021 Feb 3.

    PubMed 33549557

  • Cunningham JW, Ferreira JP, Deng H, Anker SD, Byra WM, Cleland JGF, Gheorghiade M, Lam CSP, La Police D, Mehra MR, Neaton JD, Spiro TE, van Veldhuisen DJ, Greenberg B, Zannad F. Natriuretic Peptide-Based Inclusion Criteria in a Heart Failure Clinical Trial: Insights From COMMANDER HF. JACC Heart Fail. 2020 May;8(5):359-368. doi: 10.1016/j.jchf.2019.12.009. Epub 2020 Mar 11.

    PubMed 32171760

  • Mehra MR, Vaduganathan M, Fu M, Ferreira JP, Anker SD, Cleland JGF, Lam CSP, van Veldhuisen DJ, Byra WM, Spiro TE, Deng H, Zannad F, Greenberg B. A comprehensive analysis of the effects of rivaroxaban on stroke or transient ischaemic attack in patients with heart failure, coronary artery disease, and sinus rhythm: the COMMANDER HF trial. Eur Heart J. 2019 Nov 21;40(44):3593-3602. doi: 10.1093/eurheartj/ehz427.

    PubMed 31461239

  • Greenberg B, Neaton JD, Anker SD, Byra WM, Cleland JGF, Deng H, Fu M, La Police DA, Lam CSP, Mehra MR, Nessel CC, Spiro TE, van Veldhuisen DJ, Vanden Boom CM, Zannad F. Association of Rivaroxaban With Thromboembolic Events in Patients With Heart Failure, Coronary Disease, and Sinus Rhythm: A Post Hoc Analysis of the COMMANDER HF Trial. JAMA Cardiol. 2019 Jun 1;4(6):515-523. doi: 10.1001/jamacardio.2019.1049.

    PubMed 31017637

  • Zannad F, Anker SD, Byra WM, Cleland JGF, Fu M, Gheorghiade M, Lam CSP, Mehra MR, Neaton JD, Nessel CC, Spiro TE, van Veldhuisen DJ, Greenberg B; COMMANDER HF Investigators. Rivaroxaban in Patients with Heart Failure, Sinus Rhythm, and Coronary Disease. N Engl J Med. 2018 Oct 4;379(14):1332-1342. doi: 10.1056/NEJMoa1808848. Epub 2018 Aug 27.

    PubMed 30146935

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rivaroxaban in people with Heart Failure and Coronary Artery Disease, run by Janssen Research & Development, LLC at 562 sites in 32 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 562 sites in United States, Japan, Poland, China, Russia and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event Rate of All-Cause Mortality, Myocardial Infarction (MI), or Stroke (time frame: Up to Global treatment end date (approximately 54 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01877915, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2019; AzTrials last refreshed its copy on 8 Nov 2026.

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