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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02111564




Registration number
NCT02111564
Ethics application status
Date submitted
31/03/2014
Date registered
11/04/2014
Date last updated
25/11/2019

Titles & IDs
Public title
A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients
Scientific title
Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk
Secondary ID [1] 0 0
2014-000305-13
Secondary ID [2] 0 0
CR103834
Universal Trial Number (UTN)
Trial acronym
MARINER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Respiratory Insufficiency 0 0
Stroke Acute 0 0
Infectious Diseases 0 0
Rheumatic Diseases 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rivaroxaban, 10 mg
Treatment: Drugs - Rivaroxaban, 7.5 mg
Treatment: Drugs - Placebo

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.

Placebo Comparator: Placebo - Each patient will receive matching placebo tablet once daily orally (by mouth) for 45 days.


Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: Placebo
All patients, randomly allocated to the placebo arm, will receive one placebo tablet with or without food.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time From Randomization to First Occurrence of Composite of All Symptomatic Venous Thromboembolism (VTE) and VTE Related Death Adjudicated by Clinical Event Committee (CEC)
Timepoint [1] 0 0
Up to Day 45
Primary outcome [2] 0 0
Event Rate Based on Time From Randomization to the First Occurrence of Major Bleeding Adjudicated by CEC
Timepoint [2] 0 0
From randomization to 2 days after the last dose (Day 45)
Secondary outcome [1] 0 0
Event Rate Based on Time From Randomization to First Occurrence of VTE-Related Death Adjudicated by CEC
Timepoint [1] 0 0
Up to Day 45
Secondary outcome [2] 0 0
Event Rate Based on Time From Randomization to the First Occurrence of a Symptomatic Venous Thromboembolism Event (VTE) Adjudicated by CEC
Timepoint [2] 0 0
Up to Day 45
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Up to Day 45
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Up to Day 45
Secondary outcome [5] 0 0
Event Rate Based on Time From Randomization to First Occurrence of All-Cause Mortality (ACM) Adjudicated by CEC
Timepoint [5] 0 0
Up to Day 45

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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 design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/05/2018
Sample size
Target
Accrual to date
Final
12024
Recruitment in Australia
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- Bedford Park
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- Box Hill
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- Caboolture
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- Cairns
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- Chermside
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- East Saint Kilda
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- Kogarah
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- Launceston
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- Lismore
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- Meadowbrook
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- Milton
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- Nedlands
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- Parkwood
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- Penrith
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- Redcliffe
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- South Brisbane
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- Sydney
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- VIC, Parkville
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- Box Hill
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- Parkwood
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- Penrith
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- Redcliffe
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- South Brisbane
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- Sydney
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- VIC, Parkville
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Hilleroed
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Hvidovre
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Denmark
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Tbilisi
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Germany
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Germany
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Germany
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Achaïa
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Greece
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Greece
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Patra
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Greece
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Greece
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Greece
State/province [214] 0 0
Voula
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Hungary
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Ajka
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Hungary
State/province [216] 0 0
Baja
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Hungary
State/province [217] 0 0
Balassagyarmat
Country [218] 0 0
Hungary
State/province [218] 0 0
Berettyóújfalú
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Hungary
State/province [219] 0 0
Budapest
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Hungary
State/province [220] 0 0
Cegléd
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Hungary
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Hungary
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Eger
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Hungary
State/province [223] 0 0
Farkasgyepü
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Hungary
State/province [224] 0 0
Gyula
Country [225] 0 0
Hungary
State/province [225] 0 0
Gyõr
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Hungary
State/province [226] 0 0
Gödöllo
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Hungary
State/province [227] 0 0
Hodmezovasarhely
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Hungary
State/province [228] 0 0
Kalocsa
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Hungary
State/province [229] 0 0
Kaposvar
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Hungary
State/province [230] 0 0
Kecskemet N/a
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Hungary
State/province [231] 0 0
Kecskemet
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Hungary
State/province [232] 0 0
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Hungary
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Kistarcsa
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Hungary
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Komarom
Country [235] 0 0
Hungary
State/province [235] 0 0
Miskolc
Country [236] 0 0
Hungary
State/province [236] 0 0
Nagykanizsa
Country [237] 0 0
Hungary
State/province [237] 0 0
Orosháza
Country [238] 0 0
Hungary
State/province [238] 0 0
Pecs
Country [239] 0 0
Hungary
State/province [239] 0 0
Pécs
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Hungary
State/province [240] 0 0
Szeged
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Hungary
State/province [241] 0 0
Szekesfehervar
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Hungary
State/province [242] 0 0
Szekszárd
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Hungary
State/province [243] 0 0
Szentes
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Hungary
State/province [244] 0 0
Szolnok
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Hungary
State/province [245] 0 0
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Hungary
State/province [246] 0 0
Székesfehérvár
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Hungary
State/province [247] 0 0
Sátoraljaújhely
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Hungary
State/province [248] 0 0
Zalaegerszeg
Country [249] 0 0
Israel
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Israel
State/province [250] 0 0
Hadera
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Israel
State/province [251] 0 0
Haifa
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Israel
State/province [252] 0 0
Holon
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Israel
State/province [253] 0 0
Jerusalem
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Israel
State/province [254] 0 0
Kfar-Saba
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Israel
State/province [255] 0 0
Modi'in
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Israel
State/province [256] 0 0
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Israel
State/province [257] 0 0
Petah Tikva
Country [258] 0 0
Israel
State/province [258] 0 0
Petah Tiqwa
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Israel
State/province [259] 0 0
Rehovot
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Israel
State/province [260] 0 0
Safed
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Israel
State/province [261] 0 0
Tel-Hashomer
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Israel
State/province [262] 0 0
Tiberias
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Israel
State/province [263] 0 0
Zefat
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Latvia
State/province [264] 0 0
Balvi
Country [265] 0 0
Latvia
State/province [265] 0 0
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Latvia
State/province [266] 0 0
Jekabpils
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Latvia
State/province [267] 0 0
Jelgava
Country [268] 0 0
Latvia
State/province [268] 0 0
Kraslavas Aprinkis
Country [269] 0 0
Latvia
State/province [269] 0 0
Kuldiga
Country [270] 0 0
Latvia
State/province [270] 0 0
Liepaja
Country [271] 0 0
Latvia
State/province [271] 0 0
Riga
Country [272] 0 0
Latvia
State/province [272] 0 0
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Country [273] 0 0
Lithuania
State/province [273] 0 0
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Country [274] 0 0
Lithuania
State/province [274] 0 0
Klaipeda
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Lithuania
State/province [275] 0 0
Panevezys
Country [276] 0 0
Lithuania
State/province [276] 0 0
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Lithuania
State/province [277] 0 0
Taurage
Country [278] 0 0
Lithuania
State/province [278] 0 0
Utena
Country [279] 0 0
Lithuania
State/province [279] 0 0
Vilniaus Apskritis
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Lithuania
State/province [280] 0 0
Vilnius
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Mexico
State/province [281] 0 0
Aguascalientes
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Mexico
State/province [282] 0 0
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Mexico
State/province [283] 0 0
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Mexico
State/province [284] 0 0
Merida
Country [285] 0 0
Mexico
State/province [285] 0 0
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Country [286] 0 0
Mexico
State/province [286] 0 0
San Pedro Garza Garcia
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Netherlands
State/province [287] 0 0
Alkmaar
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Netherlands
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Almelo
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Netherlands
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Amsterdam
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Netherlands
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Arnhem
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Netherlands
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Den Haag
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Netherlands
State/province [292] 0 0
Harderwijk
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Netherlands
State/province [293] 0 0
Heerlen
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Netherlands
State/province [294] 0 0
Hoorn
Country [295] 0 0
Netherlands
State/province [295] 0 0
Maastricht
Country [296] 0 0
Netherlands
State/province [296] 0 0
Nieuwegein
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Netherlands
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s-Hertogenbosch
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Netherlands
State/province [298] 0 0
Sittard-Geleen
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Netherlands
State/province [299] 0 0
Sneek
Country [300] 0 0
Netherlands
State/province [300] 0 0
Tilburg
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Netherlands
State/province [301] 0 0
Veldhoven
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Netherlands
State/province [302] 0 0
Zutphen
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Netherlands
State/province [303] 0 0
Zwolle
Country [304] 0 0
North Macedonia
State/province [304] 0 0
Bitola
Country [305] 0 0
North Macedonia
State/province [305] 0 0
Ohrid
Country [306] 0 0
North Macedonia
State/province [306] 0 0
Skopje
Country [307] 0 0
North Macedonia
State/province [307] 0 0
Struga
Country [308] 0 0
North Macedonia
State/province [308] 0 0
Štip
Country [309] 0 0
Peru
State/province [309] 0 0
Callao
Country [310] 0 0
Peru
State/province [310] 0 0
Lima
Country [311] 0 0
Poland
State/province [311] 0 0
Bialystok
Country [312] 0 0
Poland
State/province [312] 0 0
Bielsko-Biala
Country [313] 0 0
Poland
State/province [313] 0 0
Bydgoszcz
Country [314] 0 0
Poland
State/province [314] 0 0
Bystra
Country [315] 0 0
Poland
State/province [315] 0 0
Czeladz
Country [316] 0 0
Poland
State/province [316] 0 0
Gdynia
Country [317] 0 0
Poland
State/province [317] 0 0
Kielce
Country [318] 0 0
Poland
State/province [318] 0 0
Klodzko
Country [319] 0 0
Poland
State/province [319] 0 0
Krakow
Country [320] 0 0
Poland
State/province [320] 0 0
Kraków
Country [321] 0 0
Poland
State/province [321] 0 0
Leczna
Country [322] 0 0
Poland
State/province [322] 0 0
Lodz
Country [323] 0 0
Poland
State/province [323] 0 0
Lublin
Country [324] 0 0
Poland
State/province [324] 0 0
Olawa
Country [325] 0 0
Poland
State/province [325] 0 0
Ostroleka
Country [326] 0 0
Poland
State/province [326] 0 0
Ostrow Mazowiecka
Country [327] 0 0
Poland
State/province [327] 0 0
Pabianice
Country [328] 0 0
Poland
State/province [328] 0 0
Plock
Country [329] 0 0
Poland
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Poznan
Country [330] 0 0
Poland
State/province [330] 0 0
Proszowice
Country [331] 0 0
Poland
State/province [331] 0 0
Pulawy
Country [332] 0 0
Poland
State/province [332] 0 0
Rabka-Zdroj
Country [333] 0 0
Poland
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Siedlce
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Poland
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Sopot,Gdynia
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Poland
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Sosnowiec
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Poland
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Szczecin
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Poland
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Tarn W N/a
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Poland
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Torun
Country [339] 0 0
Poland
State/province [339] 0 0
Warszawa N/a
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Poland
State/province [340] 0 0
Warszawa
Country [341] 0 0
Poland
State/province [341] 0 0
Wegrow
Country [342] 0 0
Poland
State/province [342] 0 0
Wroclaw
Country [343] 0 0
Portugal
State/province [343] 0 0
Braga
Country [344] 0 0
Portugal
State/province [344] 0 0
Coimbra
Country [345] 0 0
Portugal
State/province [345] 0 0
Covilhã
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Portugal
State/province [346] 0 0
Figueira da Foz
Country [347] 0 0
Portugal
State/province [347] 0 0
Guimarães
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Portugal
State/province [348] 0 0
Lisboa
Country [349] 0 0
Portugal
State/province [349] 0 0
Porto
Country [350] 0 0
Portugal
State/province [350] 0 0
Vila Nova de Gaia
Country [351] 0 0
Puerto Rico
State/province [351] 0 0
San Juan
Country [352] 0 0
Romania
State/province [352] 0 0
Bacau
Country [353] 0 0
Romania
State/province [353] 0 0
Baia Mare
Country [354] 0 0
Romania
State/province [354] 0 0
Braila
Country [355] 0 0
Romania
State/province [355] 0 0
Brasov
Country [356] 0 0
Romania
State/province [356] 0 0
Bucuresti
Country [357] 0 0
Romania
State/province [357] 0 0
Cluj-Napoca
Country [358] 0 0
Romania
State/province [358] 0 0
Craiova
Country [359] 0 0
Romania
State/province [359] 0 0
Focsani
Country [360] 0 0
Romania
State/province [360] 0 0
Iasi
Country [361] 0 0
Romania
State/province [361] 0 0
Oradea
Country [362] 0 0
Romania
State/province [362] 0 0
Pitesti
Country [363] 0 0
Romania
State/province [363] 0 0
Tg Mures
Country [364] 0 0
Romania
State/province [364] 0 0
Timisoara
Country [365] 0 0
Russian Federation
State/province [365] 0 0
Arkhangelsk
Country [366] 0 0
Russian Federation
State/province [366] 0 0
Chelyabinsk
Country [367] 0 0
Russian Federation
State/province [367] 0 0
Ekaterinburg
Country [368] 0 0
Russian Federation
State/province [368] 0 0
Irkutsk
Country [369] 0 0
Russian Federation
State/province [369] 0 0
Kazan
Country [370] 0 0
Russian Federation
State/province [370] 0 0
Kemerovo
Country [371] 0 0
Russian Federation
State/province [371] 0 0
Krasnodar
Country [372] 0 0
Russian Federation
State/province [372] 0 0
Krasnoyarsk
Country [373] 0 0
Russian Federation
State/province [373] 0 0
Moscow
Country [374] 0 0
Russian Federation
State/province [374] 0 0
Moskva
Country [375] 0 0
Russian Federation
State/province [375] 0 0
Novosibirsk
Country [376] 0 0
Russian Federation
State/province [376] 0 0
Orenburg
Country [377] 0 0
Russian Federation
State/province [377] 0 0
Penza
Country [378] 0 0
Russian Federation
State/province [378] 0 0
Rostov on Don
Country [379] 0 0
Russian Federation
State/province [379] 0 0
Saint Petersburg
Country [380] 0 0
Russian Federation
State/province [380] 0 0
Saint-Petersburg
Country [381] 0 0
Russian Federation
State/province [381] 0 0
Saratov
Country [382] 0 0
Russian Federation
State/province [382] 0 0
Smolensk
Country [383] 0 0
Russian Federation
State/province [383] 0 0
St. Petersburg
Country [384] 0 0
Russian Federation
State/province [384] 0 0
Tomsk
Country [385] 0 0
Russian Federation
State/province [385] 0 0
Ulyanovsk
Country [386] 0 0
Russian Federation
State/province [386] 0 0
Vsevolzhsk
Country [387] 0 0
Russian Federation
State/province [387] 0 0
Yaroslavl
Country [388] 0 0
Serbia
State/province [388] 0 0
Belgrade
Country [389] 0 0
Serbia
State/province [389] 0 0
Beograd
Country [390] 0 0
Serbia
State/province [390] 0 0
Cacak
Country [391] 0 0
Serbia
State/province [391] 0 0
Cuprija
Country [392] 0 0
Serbia
State/province [392] 0 0
Dedinje
Country [393] 0 0
Serbia
State/province [393] 0 0
Kragujevac
Country [394] 0 0
Serbia
State/province [394] 0 0
Leskovac
Country [395] 0 0
Serbia
State/province [395] 0 0
Nis
Country [396] 0 0
Serbia
State/province [396] 0 0
Novi Sad
Country [397] 0 0
Serbia
State/province [397] 0 0
Sabac
Country [398] 0 0
Serbia
State/province [398] 0 0
Smederevo
Country [399] 0 0
Serbia
State/province [399] 0 0
Sremska Kamenica
Country [400] 0 0
Serbia
State/province [400] 0 0
Subotica
Country [401] 0 0
Serbia
State/province [401] 0 0
Valjevo
Country [402] 0 0
Serbia
State/province [402] 0 0
Vranje
Country [403] 0 0
Serbia
State/province [403] 0 0
Zajecar
Country [404] 0 0
Slovakia
State/province [404] 0 0
Kosice
Country [405] 0 0
Slovakia
State/province [405] 0 0
Martin
Country [406] 0 0
Slovakia
State/province [406] 0 0
Nitra
Country [407] 0 0
South Africa
State/province [407] 0 0
Bellville
Country [408] 0 0
South Africa
State/province [408] 0 0
Bloemfontein
Country [409] 0 0
South Africa
State/province [409] 0 0
Cape Town
Country [410] 0 0
South Africa
State/province [410] 0 0
Durban Kwa Zulu Natal
Country [411] 0 0
South Africa
State/province [411] 0 0
Durban
Country [412] 0 0
South Africa
State/province [412] 0 0
Gatesville Cape Town
Country [413] 0 0
South Africa
State/province [413] 0 0
Groenkloof, Pretoria
Country [414] 0 0
South Africa
State/province [414] 0 0
Johannesburg
Country [415] 0 0
South Africa
State/province [415] 0 0
Kempton Park
Country [416] 0 0
South Africa
State/province [416] 0 0
Kuils River
Country [417] 0 0
South Africa
State/province [417] 0 0
Pretoria
Country [418] 0 0
South Africa
State/province [418] 0 0
Somerset West
Country [419] 0 0
South Africa
State/province [419] 0 0
Stellenbosch
Country [420] 0 0
South Africa
State/province [420] 0 0
Worcester
Country [421] 0 0
Spain
State/province [421] 0 0
Alcalá de Henares
Country [422] 0 0
Spain
State/province [422] 0 0
Alicante
Country [423] 0 0
Spain
State/province [423] 0 0
Almeria
Country [424] 0 0
Spain
State/province [424] 0 0
Alzira
Country [425] 0 0
Spain
State/province [425] 0 0
Aranjuez
Country [426] 0 0
Spain
State/province [426] 0 0
Avila
Country [427] 0 0
Spain
State/province [427] 0 0
Balea
Country [428] 0 0
Spain
State/province [428] 0 0
Barcelona
Country [429] 0 0
Spain
State/province [429] 0 0
Burgos
Country [430] 0 0
Spain
State/province [430] 0 0
Cartagena
Country [431] 0 0
Spain
State/province [431] 0 0
Cáceres
Country [432] 0 0
Spain
State/province [432] 0 0
Don Benito
Country [433] 0 0
Spain
State/province [433] 0 0
Elche
Country [434] 0 0
Spain
State/province [434] 0 0
Getafe
Country [435] 0 0
Spain
State/province [435] 0 0
Granada
Country [436] 0 0
Spain
State/province [436] 0 0
Huelva N/a
Country [437] 0 0
Spain
State/province [437] 0 0
La Laguna
Country [438] 0 0
Spain
State/province [438] 0 0
Las Palmas de Gran Canaria
Country [439] 0 0
Spain
State/province [439] 0 0
Logroño
Country [440] 0 0
Spain
State/province [440] 0 0
Madrid
Country [441] 0 0
Spain
State/province [441] 0 0
Majadahonda-Madrid
Country [442] 0 0
Spain
State/province [442] 0 0
Malaga
Country [443] 0 0
Spain
State/province [443] 0 0
Murcia
Country [444] 0 0
Spain
State/province [444] 0 0
Móstoles
Country [445] 0 0
Spain
State/province [445] 0 0
Olot
Country [446] 0 0
Spain
State/province [446] 0 0
Oviedo
Country [447] 0 0
Spain
State/province [447] 0 0
Palma de Mallorca
Country [448] 0 0
Spain
State/province [448] 0 0
Pamplona
Country [449] 0 0
Spain
State/province [449] 0 0
Sabadell
Country [450] 0 0
Spain
State/province [450] 0 0
San Sebastian de los Reyes
Country [451] 0 0
Spain
State/province [451] 0 0
Sanchinarro
Country [452] 0 0
Spain
State/province [452] 0 0
Sant Boi de Llobregat
Country [453] 0 0
Spain
State/province [453] 0 0
Sant Joan d'Alacant
Country [454] 0 0
Spain
State/province [454] 0 0
Santander N/a
Country [455] 0 0
Spain
State/province [455] 0 0
Sarrià
Country [456] 0 0
Spain
State/province [456] 0 0
Sevilla
Country [457] 0 0
Spain
State/province [457] 0 0
Torrelavega Cantabria
Country [458] 0 0
Spain
State/province [458] 0 0
Valencia
Country [459] 0 0
Spain
State/province [459] 0 0
Zaragoza
Country [460] 0 0
Turkey
State/province [460] 0 0
Adana
Country [461] 0 0
Turkey
State/province [461] 0 0
Ankara
Country [462] 0 0
Turkey
State/province [462] 0 0
Antalya
Country [463] 0 0
Turkey
State/province [463] 0 0
Istanbul
Country [464] 0 0
Turkey
State/province [464] 0 0
Izmir
Country [465] 0 0
Turkey
State/province [465] 0 0
Konya
Country [466] 0 0
Turkey
State/province [466] 0 0
Rize
Country [467] 0 0
Turkey
State/province [467] 0 0
Samsun
Country [468] 0 0
Ukraine
State/province [468] 0 0
Cherkasy
Country [469] 0 0
Ukraine
State/province [469] 0 0
Chernihiv
Country [470] 0 0
Ukraine
State/province [470] 0 0
Dnipropetrovsk
Country [471] 0 0
Ukraine
State/province [471] 0 0
Ivano-Frankivsky
Country [472] 0 0
Ukraine
State/province [472] 0 0
Kharkiv
Country [473] 0 0
Ukraine
State/province [473] 0 0
Kherson
Country [474] 0 0
Ukraine
State/province [474] 0 0
Kyiv
Country [475] 0 0
Ukraine
State/province [475] 0 0
Lutsk
Country [476] 0 0
Ukraine
State/province [476] 0 0
Lviv
Country [477] 0 0
Ukraine
State/province [477] 0 0
Odessa
Country [478] 0 0
Ukraine
State/province [478] 0 0
Poltava
Country [479] 0 0
Ukraine
State/province [479] 0 0
Sumy
Country [480] 0 0
Ukraine
State/province [480] 0 0
Uzhgorod
Country [481] 0 0
Ukraine
State/province [481] 0 0
Vinnytsia
Country [482] 0 0
Ukraine
State/province [482] 0 0
Zaporizhzhia
Country [483] 0 0
Ukraine
State/province [483] 0 0
Zaporizhzhya
Country [484] 0 0
Ukraine
State/province [484] 0 0
Zhytomyr
Country [485] 0 0
United Kingdom
State/province [485] 0 0
Angus
Country [486] 0 0
United Kingdom
State/province [486] 0 0
Cardiff
Country [487] 0 0
United Kingdom
State/province [487] 0 0
Craigavon
Country [488] 0 0
United Kingdom
State/province [488] 0 0
Glasgow
Country [489] 0 0
United Kingdom
State/province [489] 0 0
Leeds
Country [490] 0 0
United Kingdom
State/province [490] 0 0
Manchester
Country [491] 0 0
United Kingdom
State/province [491] 0 0
Norwich
Country [492] 0 0
United Kingdom
State/province [492] 0 0
Plymouth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Bayer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02111564
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02111564