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

November 5, 2019 updated by: Janssen Research & Development, LLC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12024

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Bahia Blanca, Argentina
      • Buenos Aires, Argentina
      • Ciudad de Buenos Aires, Argentina
      • Cordoba, Argentina
      • Coronel Suarez, Argentina
      • Corrientes, Argentina
      • Córdoba, Argentina
      • Esperanza, Argentina
      • La Plata, Argentina
      • Merlo, Argentina
      • Moron, Argentina
      • Munro, Argentina
      • Rosario, Argentina
      • Santa Fe, Argentina
      • Santa Fé, Argentina
      • Tucuman, Argentina
  • Australia
      • Bedford Park, Australia
      • Box Hill, Australia
      • Caboolture, Australia
      • Cairns, Australia
      • Chermside, Australia
      • East Saint Kilda, Australia
      • Kogarah, Australia
      • Launceston, Australia
      • Lismore, Australia
      • Meadowbrook, Australia
      • Milton, Australia
      • Nedlands, Australia
      • Parkwood, Australia
      • Penrith, Australia
      • Redcliffe, Australia
      • South Brisbane, Australia
      • Sydney, Australia
      • VIC, Parkville, Australia
  • Austria
      • Feldkirch, Austria
      • Graz, Austria
      • Linz, Austria
      • Salzburg, Austria
      • Wien, Austria
  • Belarus
      • Gomel, Belarus
      • Grodno, Belarus
      • Minsk, Belarus
      • Mogilev, Belarus
      • Vitebsk, Belarus
      • Vychulki, Brest Region, Brest, Belarus
  • Bosnia and Herzegovina
      • Banja Luka, Bosnia and Herzegovina
      • Bihac, Bosnia and Herzegovina
      • Foca, Bosnia and Herzegovina
      • Mostar, Bosnia and Herzegovina
      • Sarajevo, Bosnia and Herzegovina
      • Tuzla, Bosnia and Herzegovina
      • Zenica, Bosnia and Herzegovina
  • Brazil
      • Belo Horizonte, Brazil
      • Blumenau, Brazil
      • Brasília, Brazil
      • Campina Grande do Sul, Brazil
      • Campinas, Brazil
      • Canoas, Brazil
      • Curitiba, Brazil
      • Itajaí, Brazil
      • Natal, Brazil
      • Passo Fundo, Brazil
      • Porto Alegre, Brazil
      • Recife, Brazil
      • Ribeirão Preto, Brazil
      • Salvador, Brazil
      • San Paulo, Brazil
      • Santo André, Brazil
      • Sao Paulo, Brazil
      • São José Do Rio Preto, Brazil
      • São Paulo, Brazil
      • Votuporanga, Brazil
  • Bulgaria
      • Blagoevgrad, Bulgaria
      • Burgas, Bulgaria
      • Dimitrovgrad, Bulgaria
      • Gabrovo, Bulgaria
      • Kozlodui, Bulgaria
      • Lom, Bulgaria
      • Lovech, Bulgaria
      • Montana, Bulgaria
      • Pernik, Bulgaria
      • Pleven, Bulgaria
      • Plovdiv, Bulgaria
      • Razlog, Bulgaria
      • Ruse, Bulgaria
      • Sandanski, Bulgaria
      • Sliven, Bulgaria
      • Sofia, Bulgaria
      • Veliko Tarnovo, Bulgaria
      • Vidin, Bulgaria
  • Canada
      • Quebec, Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • New Brunswick
      • Saint John, New Brunswick, Canada
    • Ontario
      • Hamilton, Ontario, Canada
      • London, Ontario, Canada
      • Ottawa, Ontario, Canada
      • Scarborough, Ontario, Canada
      • Toronto, Ontario, Canada
      • Waterloo, Ontario, Canada
    • Quebec
      • Greenfield Park, Quebec, Canada
      • Montreal, Quebec, Canada
      • Saint-Jerome, Quebec, Canada
      • Sherbrooke, Quebec, Canada
  • Colombia
      • Armenia, Colombia
      • Barranquilla, Colombia
      • Bogota, Colombia
      • Bogotá, Colombia
      • Cali, Colombia
      • Chia, Colombia
      • Floridablanca, Colombia
      • Medellin, Colombia
      • Medellín, Colombia
      • Villavicencio, Colombia
  • Croatia
      • Cakovec, Croatia
      • Karlovac, Croatia
      • Krapinske Toplice, Croatia
      • Osijek, Croatia
      • Pula, Croatia
      • Rijeka, Croatia
      • Sibenik, Croatia
      • Virovitica, Croatia
      • Zabok, Croatia
      • Zadar, Croatia
      • Zagreb, Croatia
  • Czechia
      • Boskovice, Czechia
      • Brno, Czechia
      • Cesky Krumlov, Czechia
      • Jablonec Na Nisou, Czechia
      • Karvina, Czechia
      • Kladno, Czechia
      • Krnov, Czechia
      • Kyjov, Czechia
      • Liberec, Czechia
      • Litomysl, Czechia
      • Mestec Kralove, Czechia
      • Nove Mesto na Morave, Czechia
      • Nymburk N/a, Czechia
      • Olomouc, Czechia
      • Opava, Czechia
      • Ostrava, Czechia
      • Pardubice, Czechia
      • Praha 10, Czechia
      • Praha 2, Czechia
      • Praha 4, Czechia
      • Praha 5, Czechia
      • Praha 8, Czechia
      • Pribram, Czechia
      • Písek, Czechia
      • Slany, Czechia
      • Sternberk, Czechia
      • Svitavy, Czechia
      • Teplice, Czechia
      • Trinec, Czechia
      • Trutnov, Czechia
      • Uherske Hradiste, Czechia
      • Usti Nad Labem, Czechia
      • Usti nad Orlici, Czechia
      • Zlin, Czechia
  • Denmark
      • Aalborg, Denmark
      • Copenhagen, Denmark
      • Esbjerg, Denmark
      • Frederiksberg, Denmark
      • Hellerup, Denmark
      • Hilleroed, Denmark
      • Hvidovre, Denmark
      • København S, Denmark
      • Roskilde, Denmark
  • Estonia
      • Tallinn, Estonia
  • Georgia
      • Batumi, Georgia
      • Kutaisi, Georgia
      • Marneuli, Georgia
      • Rustavi, Georgia
      • T'bilisi, Georgia
      • Tbilisi, Georgia
      • Telavi, Georgia
  • Germany
      • Berlin, Germany
      • Coburg, Germany
      • Dresden, Germany
      • Esslingen, Germany
      • Frankfurt, Germany
      • Heidelberg, Germany
      • Jülich, Germany
      • Karlsbad, Germany
      • Leipzig, Germany
      • Limburg, Germany
      • Mannheim, Germany
      • Minden, Germany
      • Mönchengladbach, Germany
      • Neuwied, Germany
      • Troisdorf, Germany
      • Witten, Germany
  • Greece
      • Achaïa, Greece
      • Alexandroupolis, Greece
      • Athens, Greece
      • Heraklion, Greece
      • Ioannina, Greece
      • Kifisia, Athens, Greece
      • Magoula, Greece
      • Patra, Greece
      • Thessaloniki, Greece
      • Thessalonikis, Greece
      • Voula, Greece
  • Hungary
      • Ajka, Hungary
      • Baja, Hungary
      • Balassagyarmat, Hungary
      • Berettyóújfalú, Hungary
      • Budapest, Hungary
      • Cegléd, Hungary
      • Debrecen, Hungary
      • Eger, Hungary
      • Farkasgyepü, Hungary
      • Gyula, Hungary
      • Gyõr, Hungary
      • Gödöllő, Hungary
      • Hodmezovasarhely, Hungary
      • Kalocsa, Hungary
      • Kaposvar, Hungary
      • Kecskemet, Hungary
      • Kecskemet N/a, Hungary
      • Keszthely, Hungary
      • Kistarcsa, Hungary
      • Komarom, Hungary
      • Miskolc, Hungary
      • Nagykanizsa, Hungary
      • Orosháza, Hungary
      • Pecs, Hungary
      • Pécs, Hungary
      • Szeged, Hungary
      • Szekesfehervar, Hungary
      • Szekszárd, Hungary
      • Szentes, Hungary
      • Szolnok, Hungary
      • Szombathely, Hungary
      • Székesfehérvár, Hungary
      • Sátoraljaújhely, Hungary
      • Zalaegerszeg, Hungary
  • Israel
      • Beersheba, Israel
      • Hadera, Israel
      • Haifa, Israel
      • Holon, Israel
      • Jerusalem, Israel
      • Kfar-Saba, Israel
      • Modi'in, Israel
      • Nahariya, Israel
      • Petah Tikva, Israel
      • Petah Tiqwa, Israel
      • Rehovot, Israel
      • Safed, Israel
      • Tel-Hashomer, Israel
      • Tiberias, Israel
      • Zefat, Israel
  • Latvia
      • Balvi, Latvia
      • Daugavpils, Latvia
      • Jekabpils, Latvia
      • Jelgava, Latvia
      • Krāslavas Apriņķis, Latvia
      • Kuldiga, Latvia
      • Liepaja, Latvia
      • Riga, Latvia
      • Ventspils, Latvia
  • Lithuania
      • Kaunas, Lithuania
      • Klaipeda, Lithuania
      • Panevezys, Lithuania
      • Siauliai, Lithuania
      • Taurage, Lithuania
      • Utena, Lithuania
      • Vilniaus Apskritis, Lithuania
      • Vilnius, Lithuania
  • Mexico
      • Aguascalientes, Mexico
      • Cuernavaca, Mexico
      • Guadalajara, Mexico
      • Merida, Mexico
      • Monterrey, Mexico
      • San Pedro Garza Garcia, Mexico
  • Netherlands
      • Alkmaar, Netherlands
      • Almelo, Netherlands
      • Amsterdam, Netherlands
      • Arnhem, Netherlands
      • Den Haag, Netherlands
      • Harderwijk, Netherlands
      • Heerlen, Netherlands
      • Hoorn, Netherlands
      • Maastricht, Netherlands
      • Nieuwegein, Netherlands
      • Sittard-Geleen, Netherlands
      • Sneek, Netherlands
      • Tilburg, Netherlands
      • Veldhoven, Netherlands
      • Zutphen, Netherlands
      • Zwolle, Netherlands
      • s-Hertogenbosch, Netherlands
  • North Macedonia
      • Bitola, North Macedonia
      • Ohrid, North Macedonia
      • Skopje, North Macedonia
      • Struga, North Macedonia
      • Štip, North Macedonia
  • Peru
      • Callao, Peru
      • Lima, Peru
  • Poland
      • Bialystok, Poland
      • Bielsko-Biala, Poland
      • Bydgoszcz, Poland
      • Bystra, Poland
      • Czeladz, Poland
      • Gdynia, Poland
      • Kielce, Poland
      • Klodzko, Poland
      • Krakow, Poland
      • Kraków, Poland
      • Leczna, Poland
      • Lodz, Poland
      • Lublin, Poland
      • Olawa, Poland
      • Ostroleka, Poland
      • Ostrow Mazowiecka, Poland
      • Pabianice, Poland
      • Plock, Poland
      • Poznan, Poland
      • Proszowice, Poland
      • Pulawy, Poland
      • Rabka-Zdroj, Poland
      • Siedlce, Poland
      • Sopot,Gdynia, Poland
      • Sosnowiec, Poland
      • Szczecin, Poland
      • Tarn W N/a, Poland
      • Torun, Poland
      • Warszawa, Poland
      • Warszawa N/a, Poland
      • Wegrow, Poland
      • Wroclaw, Poland
  • Portugal
      • Braga, Portugal
      • Coimbra, Portugal
      • Covilhã, Portugal
      • Figueira da Foz, Portugal
      • Guimarães, Portugal
      • Lisboa, Portugal
      • Porto, Portugal
      • Vila Nova de Gaia, Portugal
  • Puerto Rico
      • San Juan, Puerto Rico
  • Romania
      • Bacau, Romania
      • Baia Mare, Romania
      • Braila, Romania
      • Brasov, Romania
      • Bucuresti, Romania
      • Bucureşti, Romania
      • Cluj-Napoca, Romania
      • Craiova, Romania
      • Focsani, Romania
      • Iasi, Romania
      • Iaşi, Romania
      • Oradea, Romania
      • Pitesti, Romania
      • Tg Mures, Romania
      • Timisoara, Romania
  • Russian Federation
      • Arkhangelsk, Russian Federation
      • Chelyabinsk, Russian Federation
      • Ekaterinburg, Russian Federation
      • Irkutsk, Russian Federation
      • Kazan, Russian Federation
      • Kemerovo, Russian Federation
      • Krasnodar, Russian Federation
      • Krasnoyarsk, Russian Federation
      • Moscow, Russian Federation
      • Moskva, Russian Federation
      • Novosibirsk, Russian Federation
      • Orenburg, Russian Federation
      • Penza, Russian Federation
      • Rostov on Don, Russian Federation
      • Saint Petersburg, Russian Federation
      • Saint-Petersburg, Russian Federation
      • Saratov, Russian Federation
      • Smolensk, Russian Federation
      • St. Petersburg, Russian Federation
      • Tomsk, Russian Federation
      • Ulyanovsk, Russian Federation
      • Vsevolzhsk, Russian Federation
      • Yaroslavl, Russian Federation
  • Serbia
      • Belgrade, Serbia
      • Beograd, Serbia
      • Cacak, Serbia
      • Cuprija, Serbia
      • Dedinje, Serbia
      • Kragujevac, Serbia
      • Leskovac, Serbia
      • Nis, Serbia
      • Novi Sad, Serbia
      • Sabac, Serbia
      • Smederevo, Serbia
      • Sremska Kamenica, Serbia
      • Subotica, Serbia
      • Valjevo, Serbia
      • Vranje, Serbia
      • Zaječar, Serbia
  • Slovakia
      • Kosice, Slovakia
      • Martin, Slovakia
      • Nitra, Slovakia
  • South Africa
      • Bellville, South Africa
      • Bloemfontein, South Africa
      • Cape Town, South Africa
      • Durban, South Africa
      • Durban Kwa Zulu Natal, South Africa
      • Gatesville Cape Town, South Africa
      • Groenkloof, Pretoria, South Africa
      • Johannesburg, South Africa
      • Kempton Park, South Africa
      • Kuils River, South Africa
      • Pretoria, South Africa
      • Somerset West, South Africa
      • Stellenbosch, South Africa
      • Worcester, South Africa
  • Spain
      • Alcalá de Henares, Spain
      • Alicante, Spain
      • Almeria, Spain
      • Alzira, Spain
      • Aranjuez, Spain
      • Avila, Spain
      • Balea, Spain
      • Barcelona, Spain
      • Burgos, Spain
      • Cartagena, Spain
      • Cáceres, Spain
      • Don Benito, Spain
      • Elche, Spain
      • Getafe, Spain
      • Granada, Spain
      • Huelva N/a, Spain
      • La Laguna, Spain
      • Las Palmas de Gran Canaria, Spain
      • Logroño, Spain
      • Madrid, Spain
      • Majadahonda-Madrid, Spain
      • Malaga, Spain
      • Murcia, Spain
      • Móstoles, Spain
      • Olot, Spain
      • Oviedo, Spain
      • Palma de Mallorca, Spain
      • Pamplona, Spain
      • Sabadell, Spain
      • San Sebastian de los Reyes, Spain
      • Sanchinarro, Spain
      • Sant Boi de Llobregat, Spain
      • Sant Joan d'Alacant, Spain
      • Santander N/a, Spain
      • Sarrià, Spain
      • Sevilla, Spain
      • Torrelavega Cantabria, Spain
      • Valencia, Spain
      • Zaragoza, Spain
  • Turkey
      • Adana, Turkey
      • Ankara, Turkey
      • Antalya, Turkey
      • Istanbul, Turkey
      • Izmir, Turkey
      • Konya, Turkey
      • Rize, Turkey
      • Samsun, Turkey
  • Ukraine
      • Cherkasy, Ukraine
      • Chernihiv, Ukraine
      • Dnipropetrovsk, Ukraine
      • Ivano-Frankivsky, Ukraine
      • Kharkiv, Ukraine
      • Kherson, Ukraine
      • Kyiv, Ukraine
      • Lutsk, Ukraine
      • Lviv, Ukraine
      • Odessa, Ukraine
      • Poltava, Ukraine
      • Sumy, Ukraine
      • Uzhgorod, Ukraine
      • Vinnytsia, Ukraine
      • Zaporizhzhia, Ukraine
      • Zaporizhzhya, Ukraine
      • Zhytomyr, Ukraine
  • United Kingdom
      • Angus, United Kingdom
      • Cardiff, United Kingdom
      • Craigavon, United Kingdom
      • Glasgow, United Kingdom
      • Leeds, United Kingdom
      • Manchester, United Kingdom
      • Norwich, United Kingdom
      • Plymouth, United Kingdom
  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Mobile, Alabama, United States
      • Sheffield, Alabama, United States
    • Arizona
      • Scottsdale, Arizona, United States
    • Arkansas
      • Fort Smith, Arkansas, United States
      • Little Rock, Arkansas, United States
    • California
      • Anaheim, California, United States
      • Beverly Hills, California, United States
      • Fullerton, California, United States
      • Los Angeles, California, United States
      • Newport Beach, California, United States
      • Orange, California, United States
      • Sacramento, California, United States
      • San Jose, California, United States
      • San Marino, California, United States
      • Santa Ana, California, United States
    • Colorado
      • Colorado Springs, Colorado, United States
    • Connecticut
      • Bridgeport, Connecticut, United States
      • Danbury, Connecticut, United States
      • New Haven, Connecticut, United States
      • Waterbury, Connecticut, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Atlantis, Florida, United States
      • Bay Pines, Florida, United States
      • Bradenton, Florida, United States
      • Brandon, Florida, United States
      • Celebration, Florida, United States
      • Clearwater, Florida, United States
      • Daytona Beach, Florida, United States
      • Jacksonville, Florida, United States
      • Jacksonville Beach, Florida, United States
      • Largo, Florida, United States
      • Miami, Florida, United States
      • Orlando, Florida, United States
      • Pensacola, Florida, United States
      • Saint Cloud, Florida, United States
      • Sebring, Florida, United States
      • Tampa, Florida, United States
      • Vero Beach, Florida, United States
      • Wellington, Florida, United States
      • West Palm Beach, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Marietta, Georgia, United States
    • Idaho
      • Idaho Falls, Idaho, United States
    • Illinois
      • Chicago, Illinois, United States
      • Normal, Illinois, United States
      • North Chicago, Illinois, United States
    • Indiana
      • Hammond, Indiana, United States
      • Lafayette, Indiana, United States
      • Michigan City, Indiana, United States
    • Iowa
      • Des Moines, Iowa, United States
    • Kansas
      • Kansas City, Kansas, United States
      • Topeka, Kansas, United States
    • Louisiana
      • Alexandria, Louisiana, United States
      • Lafayette, Louisiana, United States
      • Metairie, Louisiana, United States
      • Minden, Louisiana, United States
      • New Orleans, Louisiana, United States
      • Shreveport, Louisiana, United States
      • Slidell, Louisiana, United States
    • Maine
      • Rockport, Maine, United States
    • Maryland
      • Annapolis, Maryland, United States
      • Baltimore, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Detroit, Michigan, United States
      • Royal Oak, Michigan, United States
      • Saginaw, Michigan, United States
      • Troy, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
      • Saint Paul, Minnesota, United States
    • Missouri
      • Bridgeton, Missouri, United States
      • Columbia, Missouri, United States
      • Saint Louis, Missouri, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Jersey
      • Atlantic City, New Jersey, United States
      • Bridgewater, New Jersey, United States
      • Marlton, New Jersey, United States
      • Newark, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Albany, New York, United States
      • Buffalo, New York, United States
      • Cortlandt Manor, New York, United States
      • Jamaica, New York, United States
      • Johnson City, New York, United States
      • Manhasset, New York, United States
      • New Hyde Park, New York, United States
      • New York, New York, United States
      • Staten Island, New York, United States
      • Valhalla, New York, United States
    • North Carolina
      • Durham, North Carolina, United States
      • Greensboro, North Carolina, United States
      • Raleigh, North Carolina, United States
      • Statesville, North Carolina, United States
    • Ohio
      • Canton, Ohio, United States
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
      • Maumee, Ohio, United States
      • Springfield, Ohio, United States
      • Willoughby, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Abington, Pennsylvania, United States
      • Camp Hill, Pennsylvania, United States
      • Chambersburg, Pennsylvania, United States
      • Doylestown, Pennsylvania, United States
      • Jefferson Hills, Pennsylvania, United States
      • Johnstown, Pennsylvania, United States
      • Lancaster, Pennsylvania, United States
      • Langhorne, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
      • Shippensburg, Pennsylvania, United States
    • Rhode Island
      • Pawtucket, Rhode Island, United States
    • South Carolina
      • Columbia, South Carolina, United States
      • Summerville, South Carolina, United States
    • Tennessee
      • Athens, Tennessee, United States
    • Texas
      • Amarillo, Texas, United States
      • Austin, Texas, United States
      • Channelview, Texas, United States
      • Corsicana, Texas, United States
      • Dallas, Texas, United States
      • Fort Worth, Texas, United States
      • Houston, Texas, United States
      • McAllen, Texas, United States
      • Tyler, Texas, United States
    • Virginia
      • Norfolk, Virginia, United States
      • Richmond, Virginia, United States
      • Roanoke, Virginia, United States
    • Washington
      • Richland, Washington, United States
      • Seattle, Washington, United States
    • West Virginia
      • Huntington, West Virginia, United States
    • Wisconsin
      • La Crosse, Wisconsin, United States
      • Marshfield, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Rivaroxaban
Each 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.
Drug: Rivaroxaban, 10 mg
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.
Other Names:
  • Xarelto
  • BAY59-7939
Drug: Rivaroxaban, 7.5 mg
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.
Other Names:
  • Xarelto
  • BAY59-7939
PLACEBO_COMPARATOR: Placebo
Each patient will receive matching placebo tablet once daily orally (by mouth) for 45 days.
Drug: Placebo
All patients, randomly allocated to the placebo arm, will receive one placebo tablet with or without food.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Up to Day 45
Event Rate Based on Time From Randomization to the First Occurrence of Major Bleeding Adjudicated by CEC
Time Frame: From randomization to 2 days after the last dose (Day 45)
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.
From randomization to 2 days after the last dose (Day 45)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event Rate Based on Time From Randomization to First Occurrence of VTE-Related Death Adjudicated by CEC
Time Frame: Up to Day 45
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.
Up to Day 45
Event Rate Based on Time From Randomization to the First Occurrence of a Symptomatic Venous Thromboembolism Event (VTE) Adjudicated by CEC
Time Frame: Up to Day 45
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.
Up to Day 45
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
Time Frame: Up to Day 45
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.
Up to Day 45
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
Time Frame: Up to Day 45
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.
Up to Day 45
Event Rate Based on Time From Randomization to First Occurrence of All-Cause Mortality (ACM) Adjudicated by CEC
Time Frame: Up to Day 45
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.
Up to Day 45

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Collaborators

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 7, 2014

Primary Completion (ACTUAL)

March 6, 2018

Study Completion (ACTUAL)

May 3, 2018

Study Registration Dates

First Submitted

March 31, 2014

First Submitted That Met QC Criteria

April 9, 2014

First Posted (ESTIMATE)

April 11, 2014

Study Record Updates

Last Update Posted (ACTUAL)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 5, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR103834
  • 2014-000305-13 (EUDRACT_NUMBER)
  • RIVAROXDVT3002 (OTHER: Janssen Research & Development, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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