AzTrials
AzTrials

Heart FailurePhase 3MARINERNCT02111564

A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients

A Phase 3 study testing Rivaroxaban, 10 mg and Rivaroxaban, 7.5 mg in people with Heart Failure and Respiratory Insufficiency, run by Janssen Research & Development, LLC at 593 sites in 37 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 evaluate the efficacy and safety of rivaroxaban compared with placebo in the prevention of symptomatic venous thromboembolism (VTE) events and VTE-related death post-hospital discharge in high-risk, medically ill patients. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Rivaroxaban, 10 mg and Rivaroxaban, 7.5 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12,024 participants
Where
593 sitesin 37 countries
Study dates
7 Jan 2014to 3 May 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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The duration of the index hospitalization must have been at least 3 and no more than 10 consecutive days
  • Must meet venous thromboembolism (VTE) risk criteria with a total modified Improve VTE Risk Score of: greater than or equal 4, or 3 with D-dimer > 2* upper limit of normal (ULN), or 2 with D-dimer > 2*ULN

Who cannot join

  • Any serious bleeding within 3 months prior to randomization or occurring during index hospitalization
  • Serious trauma (including head trauma) within 4 weeks before randomization
  • History of hemorrhagic stroke at any time in the past
  • Any medical condition that requires chronic use of any parenteral or oral anticoagulation

Trial locations and contacts

593 sites in 37 countries.

593 sites in 37 countries

United States135 sites

  • Study site

    Abington, Pennsylvania

  • Study site

    Albany, New York

  • Study site

    Albuquerque, New Mexico

  • Study site

    Alexandria, Louisiana

  • Study site

    Amarillo, Texas

  • Study site

    Anaheim, California

  • Study site

    Annapolis, Maryland

  • Study site

    Athens, Tennessee

  • Study site

    Atlanta, Georgia

  • Study site

    Atlantic City, New Jersey

  • Study site

    Atlantis, Florida

  • Study site

    Austin, Texas

  • Study site

    Baltimore, Maryland

  • Study site

    Bay Pines, Florida

  • Study site

    Beverly Hills, California

  • Study site

    Birmingham, Alabama

  • Study site

    Boston, Massachusetts

  • Study site

    Bradenton, Florida

  • Study site

    Brandon, Florida

  • Study site

    Bridgeport, Connecticut

  • Study site

    Bridgeton, Missouri

  • Study site

    Bridgewater, New Jersey

  • Study site

    Buffalo, New York

  • Study site

    Camp Hill, Pennsylvania

  • Study site

    Canton, Ohio

  • Study site

    Celebration, Florida

  • Study site

    Chambersburg, Pennsylvania

  • Study site

    Channelview, Texas

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Clearwater, Florida

  • Study site

    Cleveland, Ohio

  • Study site

    Colorado Springs, Colorado

  • Study site

    Columbia, Missouri

  • Study site

    Columbia, South Carolina

  • Study site

    Columbus, Ohio

  • Study site

    Corsicana, Texas

  • Study site

    Cortlandt Manor, New York

  • Study site

    Dallas, Texas

  • Study site

    Danbury, Connecticut

  • Study site

    Daytona Beach, Florida

  • Study site

    Des Moines, Iowa

  • Study site

    Detroit, Michigan

  • Study site

    Doylestown, Pennsylvania

  • Study site

    Durham, North Carolina

  • Study site

    Fort Smith, Arkansas

  • Study site

    Fort Worth, Texas

  • Study site

    Fullerton, California

  • Study site

    Greensboro, North Carolina

  • Study site

    Hammond, Indiana

  • Study site

    Houston, Texas

  • Study site

    Huntington, West Virginia

  • Study site

    Idaho Falls, Idaho

  • Study site

    Jacksonville, Florida

  • Study site

    Jacksonville Beach, Florida

  • Study site

    Jamaica, New York

  • Study site

    Jefferson Hills, Pennsylvania

  • Study site

    Johnson City, New York

  • Study site

    Johnstown, Pennsylvania

  • Study site

    Kansas City, Kansas

  • Study site

    La Crosse, Wisconsin

  • Study site

    Lafayette, Indiana

  • Study site

    Lafayette, Louisiana

  • Study site

    Lancaster, Pennsylvania

  • Study site

    Langhorne, Pennsylvania

  • Study site

    Largo, Florida

  • Study site

    Las Vegas, Nevada

  • Study site

    Little Rock, Arkansas

  • Study site

    Los Angeles, California

  • Study site

    Manhasset, New York

  • Study site

    Marietta, Georgia

  • Study site

    Marlton, New Jersey

  • Study site

    Marshfield, Wisconsin

  • Study site

    Maumee, Ohio

  • Study site

    McAllen, Texas

  • Study site

    Metairie, Louisiana

  • Study site

    Miami, Florida

  • Study site

    Michigan City, Indiana

  • Study site

    Minden, Louisiana

  • Study site

    Minneapolis, Minnesota

  • Study site

    Mobile, Alabama

  • Study site

    New Haven, Connecticut

  • Study site

    New Hyde Park, New York

  • Study site

    New Orleans, Louisiana

  • Study site

    New York, New York

  • Study site

    Newark, New Jersey

  • Study site

    Newport Beach, California

  • Study site

    Norfolk, Virginia

  • Study site

    Normal, Illinois

  • Study site

    North Chicago, Illinois

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Omaha, Nebraska

  • Study site

    Orange, California

  • Study site

    Orlando, Florida

  • Study site

    Pawtucket, Rhode Island

  • Study site

    Pensacola, Florida

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Portland, Oregon

  • Study site

    Raleigh, North Carolina

  • Study site

    Richland, Washington

  • Study site

    Richmond, Virginia

  • Study site

    Roanoke, Virginia

  • Study site

    Rockport, Maine

  • Study site

    Royal Oak, Michigan

  • Study site

    Sacramento, California

  • Study site

    Saginaw, Michigan

  • Study site

    Saint Cloud, Florida

  • Study site

    Saint Paul, Minnesota

  • Study site

    San Jose, California

  • Study site

    San Marino, California

  • Study site

    Santa Ana, California

  • Study site

    Scottsdale, Arizona

  • Study site

    Seattle, Washington

  • Study site

    Sebring, Florida

  • Study site

    Sheffield, Alabama

  • Study site

    Shippensburg, Pennsylvania

  • Study site

    Shreveport, Louisiana

  • Study site

    Slidell, Louisiana

  • Study site

    Springfield, Ohio

  • Study site

    St Louis, Missouri

  • Study site

    Staten Island, New York

  • Study site

    Statesville, North Carolina

  • Study site

    Summerville, South Carolina

  • Study site

    Tampa, Florida

  • Study site

    Topeka, Kansas

  • Study site

    Troy, Michigan

  • Study site

    Tyler, Texas

  • Study site

    Valhalla, New York

  • Study site

    Vero Beach, Florida

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Waterbury, Connecticut

  • Study site

    Wellington, Florida

  • Study site

    West Palm Beach, Florida

  • Study site

    Willoughby, Ohio

Other trials in United States

Spain39 sites

  • Study site

    Alcalá de Henares

  • Study site

    Alicante

  • Study site

    Almería

  • Study site

    Alzira

  • Study site

    Aranjuez

  • Study site

    Ávila

  • Study site

    Balea

  • Study site

    Barcelona

  • Study site

    Burgos

  • Study site

    Cáceres

  • Study site

    Cartagena

  • Study site

    Don Benito

  • Study site

    Elche

  • Study site

    Getafe

  • Study site

    Granada

  • Study site

    Huelva

  • Study site

    Las Palmas de Gran Canaria

  • Study site

    Logroño

  • Study site

    Madrid

  • Study site

    Majadahonda-Madrid

  • Study site

    Málaga

  • Study site

    Móstoles

  • Study site

    Murcia

  • Study site

    Olot

  • Study site

    Oviedo

  • Study site

    Palma de Mallorca

  • Study site

    Pamplona

  • Study site

    PAU de Sanchinarro

  • Study site

    Sabadell

  • Study site

    San Cristóbal de La Laguna

  • Study site

    San Sebastián de los Reyes

  • Study site

    Sant Boi de Llobregat

  • Study site

    Sant Joan d'Alacant

  • Study site

    Santander

  • Study site

    Sarrià

  • Study site

    Seville

  • Study site

    Torrelavega Cantabria

  • Study site

    Valencia

  • Study site

    Zaragoza

Other trials in Spain

Hungary31 sites

  • Study site

    Ajka

  • Study site

    Baja

  • Study site

    Balassagyarmat

  • Study site

    Berettyóújfalú

  • Study site

    Budapest

  • Study site

    Cegléd

  • Study site

    Debrecen

  • Study site

    Eger

  • Study site

    Farkasgyepü

  • Study site

    Gödöllő

  • Study site

    Gyõr

  • Study site

    Gyula

  • Study site

    Hódmezővásárhely

  • Study site

    Kalocsa

  • Study site

    Kaposvár

  • Study site

    Kecskemét

  • Study site

    Keszthely

  • Study site

    Kistarcsa

  • Study site

    Komárom

  • Study site

    Miskolc

  • Study site

    Nagykanizsa

  • Study site

    Orosháza

  • Study site

    Pécs

  • Study site

    Sátoraljaújhely

  • Study site

    Szeged

  • Study site

    Székesfehérvár

  • Study site

    Szekszárd

  • Study site

    Szentes

  • Study site

    Szolnok

  • Study site

    Szombathely

  • Study site

    Zalaegerszeg

Other trials in Hungary

Czechia30 sites

  • Study site

    Boskovice

  • Study site

    Brno

  • Study site

    Český Krumlov

  • Study site

    Fryštát

  • Study site

    Jablonec Na Nisou

  • Study site

    Kladno

  • Study site

    Krnov

  • Study site

    Kyjov

  • Study site

    Liberec

  • Study site

    Litomyšl

  • Study site

    Městec Králové

  • Study site

    Nové Město na Moravě

  • Study site

    Nymburk

  • Study site

    Olomouc

  • Study site

    Opava

  • Study site

    Ostrava

  • Study site

    Pardubice

  • Study site

    Písek

  • Study site

    Prague

  • Study site

    Příbram

  • Study site

    Slaný

  • Study site

    Sternberk

  • Study site

    Svitavy

  • Study site

    Teplice

  • Study site

    Třinec

  • Study site

    Trutnov

  • Study site

    Uherské Hradiště

  • Study site

    Ústí nad Labem

  • Study site

    Ústí nad Orlicí

  • Study site

    Zlín

Other trials in Czechia

Poland30 sites

  • Study site

    Bialystok

  • Study site

    Bielsko-Biala

  • Study site

    Bydgoszcz

  • Study site

    Bystra

  • Study site

    Czeladź

  • Study site

    Gdynia

  • Study site

    Kielce

  • Study site

    Kłodzko

  • Study site

    Krakow

  • Study site

    Łęczna

  • Study site

    Lodz

  • Study site

    Lublin

  • Study site

    Oława

  • Study site

    Ostrołęka

  • Study site

    Ostrów Mazowiecka

  • Study site

    Pabianice

  • Study site

    Płock

  • Study site

    Poznan

  • Study site

    Proszowice

  • Study site

    Puławy

  • Study site

    Rabka-Zdrój

  • Study site

    Siedlce

  • Study site

    Sopot,Gdynia

  • Study site

    Sosnowiec

  • Study site

    Szczecin

  • Study site

    Tarn W N/a

  • Study site

    Torun

  • Study site

    Warsaw

  • Study site

    Węgrów

  • Study site

    Wroclaw

Other trials in Poland

Russia21 sites

  • Study site

    Arkhangelsk

  • Study site

    Chelyabinsk

  • Study site

    Irkutsk

  • Study site

    Kazan'

  • Study site

    Kemerovo

  • Study site

    Krasnodar

  • Study site

    Krasnoyarsk

  • Study site

    Moscow

  • Study site

    Moskva

  • Study site

    Novosibirsk

  • Study site

    Orenburg

  • Study site

    Penza

  • Study site

    Rostov-on-Don

  • Study site

    Saint Petersburg

  • Study site

    Saratov

  • Study site

    Smolensk

  • Study site

    Tomsk

  • Study site

    Ulyanovsk

  • Study site

    Vsevolzhsk

  • Study site

    Yaroslavl

  • Study site

    Yekaterinburg

Other trials in Russia

Australia18 sites

  • Study site

    Bedford Park

  • Study site

    Box Hill

  • Study site

    Caboolture

  • Study site

    Cairns

  • Study site

    Chermside

  • Study site

    East Saint Kilda

  • Study site

    Kogarah

  • Study site

    Launceston

  • Study site

    Lismore

  • Study site

    Meadowbrook

  • Study site

    Milton

  • Study site

    Nedlands

  • Study site

    Parkwood

  • Study site

    Penrith

  • Study site

    Redcliffe

  • Study site

    South Brisbane

  • Study site

    Sydney

  • Study site

    VIC, Parkville

Other trials in Australia

Brazil18 sites

  • Study site

    Belo Horizonte

  • Study site

    Blumenau

  • Study site

    Brasília

  • Study site

    Campina Grande do Sul

  • Study site

    Campinas

  • Study site

    Canoas

  • Study site

    Curitiba

  • Study site

    Itajaí

  • Study site

    Natal

  • Study site

    Passo Fundo

  • Study site

    Porto Alegre

  • Study site

    Recife

  • Study site

    Ribeirão Preto

  • Study site

    Salvador

  • Study site

    Santo André

  • Study site

    São José do Rio Preto

  • Study site

    São Paulo

  • Study site

    Votuporanga

Other trials in Brazil

Bulgaria18 sites

  • Study site

    Blagoevgrad

  • Study site

    Burgas

  • Study site

    Dimitrovgrad

  • Study site

    Gabrovo

  • Study site

    Kozloduy

  • Study site

    Lom

  • Study site

    Lovech

  • Study site

    Montana

  • Study site

    Pernik

  • Study site

    Pleven

  • Study site

    Plovdiv

  • Study site

    Razlog

  • Study site

    Rousse

  • Study site

    Sandanski

  • Study site

    Sliven

  • Study site

    Sofia

  • Study site

    Veliko Tarnovo

  • Study site

    Vidin

Other trials in Bulgaria

Netherlands17 sites

  • Study site

    's-Hertogenbosch

  • Study site

    Alkmaar

  • Study site

    Almelo

  • Study site

    Amsterdam

  • Study site

    Arnhem

  • Study site

    Harderwijk

  • Study site

    Heerlen

  • Study site

    Hoorn

  • Study site

    Maastricht

  • Study site

    Nieuwegein

  • Study site

    Sittard-Geleen

  • Study site

    Sneek

  • Study site

    The Hague

  • Study site

    Tilburg

  • Study site

    Veldhoven

  • Study site

    Zutphen

  • Study site

    Zwolle

Other trials in Netherlands

Germany16 sites

  • Study site

    Berlin

  • Study site

    Coburg

  • Study site

    Dresden

  • Study site

    Esslingen am Neckar

  • Study site

    Frankfurt

  • Study site

    Heidelberg

  • Study site

    Jülich

  • Study site

    Karlsbad

  • Study site

    Leipzig

  • Study site

    Limburg

  • Study site

    Mannheim

  • Study site

    Minden

  • Study site

    Mönchengladbach

  • Study site

    Neuwied

  • Study site

    Troisdorf

  • Study site

    Witten

Other trials in Germany

Ukraine16 sites

  • Study site

    Cherkasy

  • Study site

    Chernihiv

  • Study site

    Dnipropetrovsk

  • Study site

    Ivano-Frankivsky

  • Study site

    Kharkiv

  • Study site

    Kherson

  • Study site

    Kyiv

  • Study site

    Lutsk

  • Study site

    Lviv

  • Study site

    Odesa

  • Study site

    Poltava

  • Study site

    Sumy

  • Study site

    Uzhhorod

  • Study site

    Vinnytsia

  • Study site

    Zaporizhzhya

  • Study site

    Zhytomyr

Other trials in Ukraine

Serbia15 sites

  • Study site

    Belgrade

  • Study site

    Čačak

  • Study site

    Ćuprija

  • Study site

    Dedinje

  • Study site

    Kamenitz

  • Study site

    Kragujevac

  • Study site

    Leskovac

  • Study site

    Niš

  • Study site

    Novi Sad

  • Study site

    Šabac

  • Study site

    Smederevo

  • Study site

    Subotica

  • Study site

    Valjevo

  • Study site

    Vranje

  • Study site

    Zaječar

Other trials in Serbia

Argentina14 sites

  • Study site

    Bahía Blanca

  • Study site

    Buenos Aires

  • Study site

    Ciudad de Buenos Aires

  • Study site

    Córdoba

  • Study site

    Coronel Suárez

  • Study site

    Corrientes

  • Study site

    Esperanza

  • Study site

    La Plata

  • Study site

    Merlo

  • Study site

    Morón

  • Study site

    Munro

  • Study site

    Rosario

  • Study site

    San Miguel de Tucumán

  • Study site

    Santa Fe

Other trials in Argentina

South Africa14 sites

  • Study site

    Bellville

  • Study site

    Bloemfontein

  • Study site

    Cape Town

  • Study site

    Durban

  • Study site

    Durban Kwa Zulu Natal

  • Study site

    Gatesville Cape Town

  • Study site

    Groenkloof, Pretoria

  • Study site

    Johannesburg

  • Study site

    Kempton Park

  • Study site

    Kuils River

  • Study site

    Pretoria

  • Study site

    Somerset West

  • Study site

    Stellenbosch

  • Study site

    Worcester

Other trials in South Africa

Canada13 sites

  • Study site

    Edmonton, Alberta

  • Study site

    Greenfield Park, Quebec

  • Study site

    Hamilton, Ontario

  • Study site

    London, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Ottawa, Ontario

  • Study site

    Québec, Quebec

  • Study site

    Saint John, New Brunswick

  • Study site

    Saint-Jérôme, Quebec

  • Study site

    Scarborough Village, Ontario

  • Study site

    Sherbrooke, Quebec

  • Study site

    Toronto, Ontario

  • Study site

    Waterloo, Ontario

Other trials in Canada

Israel13 sites

  • Study site

    Beersheba

  • Study site

    Hadera

  • Study site

    Haifa

  • Study site

    Holon

  • Study site

    Jerusalem

  • Study site

    Kfar Saba

  • Study site

    Modiin

  • Study site

    Nahariya

  • Study site

    Petah Tikva

  • Study site

    Rehovot

  • Study site

    Safed

  • Study site

    Tel HaShomer

  • Study site

    Tiberias

Other trials in Israel

Romania13 sites

  • Study site

    Bacau

  • Study site

    Baia Mare

  • Study site

    Brăila

  • Study site

    Brasov

  • Study site

    Bucharest

  • Study site

    Cluj-Napoca

  • Study site

    Craiova

  • Study site

    Focşani

  • Study site

    Iași

  • Study site

    Oradea

  • Study site

    Piteşti

  • Study site

    Tg Mures

  • Study site

    Timișoara

Other trials in Romania

Croatia11 sites

  • Study site

    Čakovec

  • Study site

    Karlovac

  • Study site

    Krapinske Toplice

  • Study site

    Osijek

  • Study site

    Pula

  • Study site

    Rijeka

  • Study site

    Šibenik

  • Study site

    Virovitica

  • Study site

    Zabok

  • Study site

    Zadar

  • Study site

    Zagreb

Other trials in Croatia

Greece11 sites

  • Study site

    Achaïa

  • Study site

    Alexandroupoli

  • Study site

    Athens

  • Study site

    Heraklion

  • Study site

    Ioannina

  • Study site

    Kifisia, Athens

  • Study site

    Magoula

  • Study site

    Pátrai

  • Study site

    Thessaloniki

  • Study site

    Thessalonikis

  • Study site

    Voula

Other trials in Greece

Denmark9 sites

  • Study site

    Aalborg

  • Study site

    Copenhagen

  • Study site

    Esbjerg

  • Study site

    Frederiksberg

  • Study site

    Hellerup

  • Study site

    Hilleroed

  • Study site

    Hvidovre

  • Study site

    København S

  • Study site

    Roskilde

Other trials in Denmark

Latvia9 sites

  • Study site

    Balvi

  • Study site

    Daugavpils

  • Study site

    Jēkabpils

  • Study site

    Jelgava

  • Study site

    Krāslavas Apriņķis

  • Study site

    Kuldīga

  • Study site

    Liepāja

  • Study site

    Riga

  • Study site

    Ventspils

Other trials in Latvia

Colombia8 sites

  • Study site

    Armenia

  • Study site

    Barranquilla

  • Study site

    Bogotá

  • Study site

    Cali

  • Study site

    Chía

  • Study site

    Floridablanca

  • Study site

    Medellín

  • Study site

    Villavicencio

Other trials in Colombia

Lithuania8 sites

  • Study site

    Kaunas

  • Study site

    Klaipėda

  • Study site

    Panevezys

  • Study site

    Šiauliai

  • Study site

    Tauragė

  • Study site

    Utena

  • Study site

    Vilniaus Apskritis

  • Study site

    Vilnius

Other trials in Lithuania

Portugal8 sites

  • Study site

    Braga

  • Study site

    Coimbra

  • Study site

    Covilha

  • Study site

    Figueira da Foz Municipality

  • Study site

    Guimarães

  • Study site

    Lisbon

  • Study site

    Porto

  • Study site

    Vila Nova de Gaia

Other trials in Portugal

Turkey (Türkiye)8 sites

  • Study site

    Adana

  • Study site

    Ankara

  • Study site

    Antalya

  • Study site

    Istanbul

  • Study site

    Izmir

  • Study site

    Konya

  • Study site

    Rize

  • Study site

    Samsun

Other trials in Turkey (Türkiye)

United Kingdom8 sites

  • Study site

    Angus

  • Study site

    Cardiff

  • Study site

    Craigavon

  • Study site

    Glasgow

  • Study site

    Leeds

  • Study site

    Manchester

  • Study site

    Norwich

  • Study site

    Plymouth

Other trials in United Kingdom

Bosnia and Herzegovina7 sites

  • Study site

    Banja Luka

  • Study site

    Bihać

  • Study site

    Foca

  • Study site

    Mostar

  • Study site

    Sarajevo

  • Study site

    Tuzla

  • Study site

    Zenica

Other trials in Bosnia and Herzegovina

Belarus6 sites

  • Study site

    Grodno

  • Study site

    Homyel

  • Study site

    Minsk

  • Study site

    Mogilev

  • Study site

    Vitebsk

  • Study site

    Vychulki, Brest Region, Brest

Other trials in Belarus

Georgia6 sites

  • Study site

    Batumi

  • Study site

    Kutaisi

  • Study site

    Marneuli

  • Study site

    Rustavi

  • Study site

    Tbilisi

  • Study site

    Telavi

Other trials in Georgia

Mexico6 sites

  • Study site

    Aguascalientes

  • Study site

    Cuernavaca

  • Study site

    Guadalajara

  • Study site

    Mérida

  • Study site

    Monterrey

  • Study site

    San Pedro Garza García

Other trials in Mexico

Austria5 sites

  • Study site

    Feldkirch

  • Study site

    Graz

  • Study site

    Linz

  • Study site

    Salzburg

  • Study site

    Vienna

Other trials in Austria

North Macedonia5 sites

  • Study site

    Bitola

  • Study site

    Ohrid

  • Study site

    Shtip

  • Study site

    Skopje

  • Study site

    Struga

Other trials in North Macedonia

Slovakia3 sites

  • Study site

    Košice

  • Study site

    Martin

  • Study site

    Nitra

Other trials in Slovakia

Peru2 sites

  • Study site

    Callao

  • Study site

    Lima

Other trials in Peru

Estonia1 site

  • Study site

    Tallinn

Other trials in Estonia

Puerto Rico1 site

  • Study site

    San Juan

Other trials in Puerto Rico

About this study

Official title: Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk

The purpose of this study is to evaluate the efficacy and safety of rivaroxaban compared with placebo in the prevention of symptomatic venous thromboembolism (VTE) events and VTE-related death post-hospital discharge in high-risk, medically ill patients.

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), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect)-controlled, event-driven, multicenter study in patients who are hospitalized for a specific acute medical illness and have other risk factors for venous thromboembolism (VTE). The study is designed to evaluate rivaroxaban in the prevention of symptomatic VTE events and VTE-related deaths for a period of 45 days post-hospital discharge. The study will consist of a screening phase, a 45-day double-blind treatment phase, and a 30-day follow-up phase. Study drug will start at randomization (Day 1), and will continue until Day 45 (inclusive). A total of approximately 12000 patients will be randomly assigned to either rivaroxaban or placebo in a 1:1 ratio. The total duration for a patient who completes the study after randomization is expected to be 75 days.

Being tested
Rivaroxaban, 10 mg, Rivaroxaban, 7.5 mg, Placebo
Keywords
Heart Failure, Respiratory Insufficiency, Stroke Acute, Infectious Diseases, Rheumatic Diseases, Medically ill Patient, Rivaroxaban, Thromboembolism, Prophylactic Anti-Coagulation
Medical subject headings
Heart Failure, Respiratory Insufficiency, Stroke, Communicable Diseases, Rheumatic Diseases, Thromboembolism

What participants receive

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

  • Rivaroxaban, 10 mgDrug

    Also called Xarelto, BAY59-7939

    Patients, randomly allocated to the rivaroxaban arm, with a creatinine clearance at screening greater than or equal to (>=)50 mL/min will receive 10 mg rivaroxaban tablet with or without food.

  • Rivaroxaban, 7.5 mgDrug

    Also called Xarelto, BAY59-7939

    Patients, randomly allocated to the rivaroxaban arm, with a creatinine clearance at screening from >=30 to less than (<)50 mL/min will receive 7.5 mg rivaroxaban tablet with or without food.

  • PlaceboDrug

    All patients, randomly allocated to the placebo arm, will receive one placebo tablet with or without food.

Study groups in NCT02111564
Study groupRoleWhat they receive
RivaroxabanExperimentalEach patient will receive either 10 mg or 7.5 mg rivaroxaban tablet once daily orally (by mouth) for 45 days. The dosing will depend on a creatinine clearance at screening.
Receives: Drug: Rivaroxaban, 10 mg; Drug: Rivaroxaban, 7.5 mg
PlaceboPlacebo comparatorEach patient will receive matching placebo tablet once daily orally (by mouth) for 45 days.
Receives: Drug: Placebo

What is being measured

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

  1. Time From Randomization to First Occurrence of Composite of All Symptomatic Venous Thromboembolism (VTE) and VTE Related Death Adjudicated by Clinical Event Committee (CEC)

    Symptomatic VTE included lower extremity deep vein thrombosis (DVT) and non-fatal pulmonary embolism (PE). Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.

    Measured: Up to Day 45

  2. Event Rate Based on Time From Randomization to the First Occurrence of Major Bleeding Adjudicated by CEC

    A major bleeding event was defined using validated International Society on Thrombosis and Haemostasis (ISTH) bleeding criteria. A major bleeding event was defined as overt bleeding that was associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more, or a transfusion of 2 or more units of packed red blood cells or whole blood, or a critical site defined as intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or a fatal outcome. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or last dose + 2 days.

    Measured: From randomization to 2 days after the last dose (Day 45)

Secondary outcomes (5)

  1. Event Rate Based on Time From Randomization to First Occurrence of VTE-Related Death Adjudicated by CEC

    Event rate based on time from randomization to first occurrence of VTE-related death (adjudicated by CEC) was assessed. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.

    Measured: Up to Day 45

  2. Event Rate Based on Time From Randomization to the First Occurrence of a Symptomatic Venous Thromboembolism Event (VTE) Adjudicated by CEC

    Event rate based on time from randomization to the first occurrence of a symptomatic VTE (adjudicated by CEC) was assessed. Symptomatic VTE included lower extremity DVT and non-fatal PE. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.

    Measured: Up to Day 45

  3. Event Rate Based on Time From Randomization to the First Occurrence of a Composite of Symptomatic VTE and All-Cause Mortality (ACM) Adjudicated by CEC

    Event rate based on time from randomization to the first occurrence of a composite of symptomatic VTE and ACM (adjudicated by CEC) was assessed. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.

    Measured: Up to Day 45

  4. Event Rate Based on Time From Randomization to the First Occurrence of a Composite of Symptomatic VTE, Myocardial Infarction (MI), Non-Hemorrhagic Stroke, and Cardiovascular (CV) Death Adjudicated by CEC

    Event rate based on time from randomization to the first occurrence of a composite of symptomatic VTE (lower extremity DVT and non-fatal PE), MI, non-hemorrhagic stroke, and CV death (death due to a known CV cause and death in which a CV cause cannot be ruled out; by this definition, a VTE-related death was considered a CV death) as adjudicated by CEC was reported. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.

    Measured: Up to Day 45

  5. Event Rate Based on Time From Randomization to First Occurrence of All-Cause Mortality (ACM) Adjudicated by CEC

    Event rate based on time from randomization to first occurrence of ACM (adjudicated by CEC) was assessed. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.

    Measured: Up to Day 45

Timeline

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

  1. First posted11 Apr 2014 (estimated)
  2. Study start7 Jan 2014
  3. Primary completion6 Mar 2018
  4. Study completion3 May 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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
12,024 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02111564
Sponsor's protocol ID
CR103834
Other IDs
2014-000305-13, RIVAROXDVT3002, 2014
Acronym
MARINER
Status last verified
Nov 2019
First submitted
31 Mar 2014
Last updated
25 Nov 2019
Data monitoring committee
Yes
FDA-regulated device
No

Publications

  • Raskob GE, Spyropoulos AC, Zrubek J, Ageno W, Albers G, Elliott CG, Halperin J, Haskell L, Hiatt WR, Maynard GA, Peters G, Spiro T, Steg PG, Suh EY, Weitz JI. The MARINER trial of rivaroxaban after hospital discharge for medical patients at high risk of VTE. Design, rationale, and clinical implications. Thromb Haemost. 2016 Jun 2;115(6):1240-8. doi: 10.1160/TH15-09-0756. Epub 2016 Feb 4.

    PubMed 26842902

  • Raskob GE, Ageno W, Albers G, Elliott CG, Halperin J, Maynard G, Steg PG, Weitz JI, Albanese J, Yuan Z, Levitan B, Lu W, Suh EY, Spiro T, Lipardi C, Barnathan ES, Spyropoulos AC. Benefit-Risk Assessment of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness. J Am Heart Assoc. 2022 Oct 18;11(20):e026229. doi: 10.1161/JAHA.122.026229. Epub 2022 Oct 7.

    PubMed 36205248

  • Spyropoulos AC, Raskob GE, Cohen AT, Ageno W, Weitz JI, Spiro TE, Lu W, Lipardi C, Albers GW, Elliott CG, Halperin JL, Hiatt WR, Maynard G, Steg PG, Sugarmann C, Barnathan ES. Association of Bleeding Severity With Mortality in Extended Thromboprophylaxis of Medically Ill Patients in the MAGELLAN and MARINER Trials. Circulation. 2022 May 10;145(19):1471-1479. doi: 10.1161/CIRCULATIONAHA.121.057847. Epub 2022 Apr 7.

    PubMed 35389229

  • Raskob GE, Spyropoulos AC, Spiro TE, Lu W, Yuan Z, Levitan B, Suh E, Barnathan ES. Benefit-Risk of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness: Pooled Analysis From MAGELLAN and MARINER. J Am Heart Assoc. 2021 Nov 16;10(22):e021579. doi: 10.1161/JAHA.121.021579. Epub 2021 Nov 10.

    PubMed 34755519

  • Jamil A, Jamil U, Singh K, Khan F, Chi G. Extended Thromboprophylaxis With Betrixaban or Rivaroxaban for Acutely Ill Hospitalized Medical Patients: Meta-Analysis of Prespecified Subgroups. Crit Pathw Cardiol. 2021 Mar 1;20(1):16-24. doi: 10.1097/HPC.0000000000000232.

    PubMed 32657973

  • Spyropoulos AC, Ageno W, Albers GW, Elliott CG, Halperin JL, Hiatt WR, Maynard GA, Steg PG, Weitz JI, Lu W, Spiro TE, Barnathan ES, Raskob GE. Post-Discharge Prophylaxis With Rivaroxaban Reduces Fatal and Major Thromboembolic Events in Medically Ill Patients. J Am Coll Cardiol. 2020 Jun 30;75(25):3140-3147. doi: 10.1016/j.jacc.2020.04.071.

    PubMed 32586587

  • Weitz JI, Raskob GE, Spyropoulos AC, Spiro TE, De Sanctis Y, Xu J, Lu W, Suh E, Argenti D, Yang H, Albanese J, Lipardi C, Barnathan ES. Thromboprophylaxis with Rivaroxaban in Acutely Ill Medical Patients with Renal Impairment: Insights from the MAGELLAN and MARINER Trials. Thromb Haemost. 2020 Mar;120(3):515-524. doi: 10.1055/s-0039-1701009. Epub 2020 Jan 23.

    PubMed 31975354

  • Spyropoulos AC, Ageno W, Albers GW, Elliott CG, Halperin JL, Hiatt WR, Maynard GA, Steg PG, Weitz JI, Suh E, Spiro TE, Barnathan ES, Raskob GE; MARINER Investigators. Rivaroxaban for Thromboprophylaxis after Hospitalization for Medical Illness. N Engl J Med. 2018 Sep 20;379(12):1118-1127. doi: 10.1056/NEJMoa1805090. Epub 2018 Aug 26.

    PubMed 30145946

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rivaroxaban, 10 mg and Rivaroxaban, 7.5 mg in people with Heart Failure and Respiratory Insufficiency, run by Janssen Research & Development, LLC at 593 sites in 37 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 2 inclusion and 4 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 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 593 sites in United States, Spain, Hungary, Czechia, Poland and 32 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 25 Nov 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?

Time From Randomization to First Occurrence of Composite of All Symptomatic Venous Thromboembolism (VTE) and VTE Related Death Adjudicated by Clinical Event Committee (CEC) (time frame: Up to Day 45). 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 NCT02111564, which also lists 8 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 25 Nov 2019; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in