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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00571649




Registration number
NCT00571649
Ethics application status
Date submitted
11/12/2007
Date registered
12/12/2007
Date last updated
15/09/2016

Titles & IDs
Public title
Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients
Scientific title
Multicenter, Randomized, Parallel-group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Medically Ill Patients Comparing Rivaroxaban With Enoxaparin. The MAGELLAN Study
Secondary ID [1] 0 0
2007-004614-14
Secondary ID [2] 0 0
12839
Universal Trial Number (UTN)
Trial acronym
MAGELLAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rivaroxaban (Xarelto, BAY59-7939)
Treatment: Drugs - Enoxaparin
Treatment: Drugs - Rivaroxaban placebo
Treatment: Drugs - Enoxaparin placebo

Experimental: Rivaroxaban (Xarelto, BAY59-7939) - Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days

Active Comparator: Enoxaparin - Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days


Treatment: Drugs: Rivaroxaban (Xarelto, BAY59-7939)
Oral rivaroxaban 10 mg once daily administered for 35 +/- 4 days

Treatment: Drugs: Enoxaparin
Subcutaneous enoxaparin 40 mg once daily (OD) administered for 10 +/- 4 days

Treatment: Drugs: Rivaroxaban placebo
Oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days

Treatment: Drugs: Enoxaparin placebo
Subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Composite Endpoint of Venous Thromboembolism [VTE] (Any Deep Vein Thrombosis [DVT], Non Fatal Pulmonary Embolism [PE]) and VTE-related Death up to Day 35 + 6 Days - A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.
Timepoint [1] 0 0
Up to Day 35 + 6 days
Primary outcome [2] 0 0
Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days - A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.
Timepoint [2] 0 0
Up to Day 10 + 5 days
Secondary outcome [1] 0 0
Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and All-cause Mortality up to Day 35 + 6 Days - A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and death (VTE-related and not VTE-related).
Timepoint [1] 0 0
Up to Day 35 + 6 days
Secondary outcome [2] 0 0
Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days Per mITT Population - A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.
Timepoint [2] 0 0
Up to Day 10 + 5 days
Secondary outcome [3] 0 0
Percentage of Participants With VTE Combined With All-cause Mortality up to Day 10 + 5 Days - A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and death (VTE-related and not VTE-related).
Timepoint [3] 0 0
Up to Day 10 + 5 days
Secondary outcome [4] 0 0
Percentage of Participants With Symptomatic VTE, Including and Excluding VTE-related Death up to Days 10, 35, and 90 - Symptomatic VTE (non-fatal PE and DVT in lower extremity), including and excluding VTE-related death (PE and PE cannot be excluded) up to Days 10, 35, and 90
Timepoint [4] 0 0
At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days
Secondary outcome [5] 0 0
Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 35 + 6 Days - Net clinical benefit is a composite of the primary efficacy endpoint (asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death) plus major and clinically relevant non-major bleeding events.
Timepoint [5] 0 0
Up to Day 35 + 6 days
Secondary outcome [6] 0 0
Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 10 + 5 Days - Net clinical benefit is a composite of the primary efficacy endpoint (asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death) plus major and clinically relevant non-major bleeding events
Timepoint [6] 0 0
Up to Day 10 + 5 days
Secondary outcome [7] 0 0
Percentage of Participants With Major Vascular Events up to Days 10, 35, and 90 - Major vascular events included cardiovascular death, acute myocardial infarction (MI), or acute ischemic stroke. Participants may have had a vascular event in more than one category.
Timepoint [7] 0 0
At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days
Secondary outcome [8] 0 0
Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 35 + 6 Days - The components of the composite endpoint include asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.
Timepoint [8] 0 0
Up to Day 35 + 6 days
Secondary outcome [9] 0 0
Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days - The components of the composite endpoint include asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.
Timepoint [9] 0 0
Up to Day 10 + 5 days
Secondary outcome [10] 0 0
Percentage of Participants With All-cause Mortality up to Day 90 + 7 Days - All deaths, including VTE-related deaths, cardiovascular deaths, and other deaths.
Timepoint [10] 0 0
Up to Day 90 + 7 days
Secondary outcome [11] 0 0
Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Intake of Any Study Medication (Day 35 + 6 Days) - Major bleeding events were defined as events leading to >=2 g/dL fall in hemoglobin; or transfusion of >= 2 units of packed RBCs (Red blood cells) or whole blood; or leading to death. Non-major bleeding events were defined as overt bleeding not meeting the criteria of major bleeding
Timepoint [11] 0 0
Up to Day 35 + 6 days
Secondary outcome [12] 0 0
Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Application of a Study Medication Syringe (Day 10 + 5 Days) - Major bleeding events were defined as events leading to >=2 g/dL fall in hemoglobin or transfusion of >=2 units of packed RBCs or whole blood or leading to death. Non-major bleeding events were defined as overt bleeding not meeting the criteria of major bleeding.
Timepoint [12] 0 0
Up to Day 10 + 5 days

Eligibility
Key inclusion criteria
- Male and female patients aged 40 years or more

- Patients at risk of venous thromboembolic events being hospitalized for acute medical
conditions as follows:

- Heart failure, New York Heart Association (NYHA) class III or IV

- Active cancer

- Acute ischemic stroke

- Acute infectious and inflammatory diseases, including acute rheumatic diseases

- Acute respiratory insufficiency

- Additional risk factor for VTE, including reduced mobility
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Conditions that contraindicate the use of antithrombotic therapy with the Low
Molecular-Weight Heparin (LMWH) enoxaparin

- Conditions that may increase the risk of bleeding, including intracranial hemorrhage

- Required drugs or procedures which may interfere with the study treatment

- Concomitant conditions or diseases which may increase the risk of study subjects or
interfere with the study outcome

- General conditions in which subjects are not suitable to participate in the study

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
The people assessing the outcomes
The people analysing the results/data
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
- Garran
Recruitment hospital [2] 0 0
- Kogarah
Recruitment hospital [3] 0 0
- Lismore
Recruitment hospital [4] 0 0
- Sydney
Recruitment hospital [5] 0 0
- Auchenflower
Recruitment hospital [6] 0 0
- Brisbane
Recruitment hospital [7] 0 0
- Redcliffe
Recruitment hospital [8] 0 0
- Southport
Recruitment hospital [9] 0 0
- Woollongabba
Recruitment hospital [10] 0 0
- Adelaide
Recruitment hospital [11] 0 0
- Launceston
Recruitment hospital [12] 0 0
- Box Hill
Recruitment hospital [13] 0 0
- Clayton
Recruitment hospital [14] 0 0
- Melbourne
Recruitment hospital [15] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2480 - Lismore
Recruitment postcode(s) [4] 0 0
2229 - Sydney
Recruitment postcode(s) [5] 0 0
4066 - Auchenflower
Recruitment postcode(s) [6] 0 0
4066 - Brisbane
Recruitment postcode(s) [7] 0 0
4101 - Brisbane
Recruitment postcode(s) [8] 0 0
4020 - Redcliffe
Recruitment postcode(s) [9] 0 0
4215 - Southport
Recruitment postcode(s) [10] 0 0
4102 - Woollongabba
Recruitment postcode(s) [11] 0 0
5042 - Adelaide
Recruitment postcode(s) [12] 0 0
7250 - Launceston
Recruitment postcode(s) [13] 0 0
3128 - Box Hill
Recruitment postcode(s) [14] 0 0
3168 - Clayton
Recruitment postcode(s) [15] 0 0
3135 - Melbourne
Recruitment postcode(s) [16] 0 0
3144 - Melbourne
Recruitment postcode(s) [17] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Delaware
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Georgia
Country [10] 0 0
United States of America
State/province [10] 0 0
Idaho
Country [11] 0 0
United States of America
State/province [11] 0 0
Illinois
Country [12] 0 0
United States of America
State/province [12] 0 0
Indiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Iowa
Country [14] 0 0
United States of America
State/province [14] 0 0
Kansas
Country [15] 0 0
United States of America
State/province [15] 0 0
Louisiana
Country [16] 0 0
United States of America
State/province [16] 0 0
Maine
Country [17] 0 0
United States of America
State/province [17] 0 0
Maryland
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United States of America
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Massachusetts
Country [19] 0 0
United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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Missouri
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United States of America
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Montana
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United States of America
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Nebraska
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United States of America
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New Jersey
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New York
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North Carolina
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United States of America
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North Dakota
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Utah
Country [34] 0 0
United States of America
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Virginia
Country [35] 0 0
United States of America
State/province [35] 0 0
Washington
Country [36] 0 0
United States of America
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West Virginia
Country [37] 0 0
Argentina
State/province [37] 0 0
Buenos Aires
Country [38] 0 0
Argentina
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Ciudad Auton. de Buenos Aires
Country [39] 0 0
Argentina
State/province [39] 0 0
Vicente López
Country [40] 0 0
Austria
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Burgenland
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Austria
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Kärnten
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Austria
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Oberösterreich
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Austria
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Steiermark
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Austria
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Tirol
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Austria
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Innsbruck
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Austria
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Linz
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Austria
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Mürzzuschlag
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Austria
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St. Pölten
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Austria
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Wien
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Belgium
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Aalst
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Belgium
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Brugge
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Belgium
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Bruxelles - Brussel
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Belgium
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Dendermonde
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Belgium
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Hasselt
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Belgium
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HUY
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Belgium
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Ieper
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Belgium
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Leuven
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Belgium
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Malmedy
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Belgium
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MOL
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Belgium
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Montigny S/sambre
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Belgium
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Mortsel
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Belgium
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Roeselare
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Belgium
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Sint-niklaas
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Belgium
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Tubize
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Belgium
State/province [65] 0 0
Turnhout
Country [66] 0 0
Brazil
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Parana
Country [67] 0 0
Brazil
State/province [67] 0 0
Rio Grande do Sul
Country [68] 0 0
Brazil
State/province [68] 0 0
Sao Paulo
Country [69] 0 0
Bulgaria
State/province [69] 0 0
Pleven
Country [70] 0 0
Bulgaria
State/province [70] 0 0
Ruse
Country [71] 0 0
Bulgaria
State/province [71] 0 0
Sofia
Country [72] 0 0
Bulgaria
State/province [72] 0 0
Stara Zagora
Country [73] 0 0
Bulgaria
State/province [73] 0 0
Varna
Country [74] 0 0
Bulgaria
State/province [74] 0 0
Veliko Tarnovo
Country [75] 0 0
Canada
State/province [75] 0 0
Alberta
Country [76] 0 0
Canada
State/province [76] 0 0
British Columbia
Country [77] 0 0
Canada
State/province [77] 0 0
New Brunswick
Country [78] 0 0
Canada
State/province [78] 0 0
Ontario
Country [79] 0 0
Canada
State/province [79] 0 0
Quebec
Country [80] 0 0
Chile
State/province [80] 0 0
Santiago
Country [81] 0 0
Chile
State/province [81] 0 0
Viña del Mar
Country [82] 0 0
China
State/province [82] 0 0
Guangdong
Country [83] 0 0
China
State/province [83] 0 0
Hunan
Country [84] 0 0
China
State/province [84] 0 0
Jiangsu
Country [85] 0 0
China
State/province [85] 0 0
Jilin
Country [86] 0 0
China
State/province [86] 0 0
Liaoning
Country [87] 0 0
China
State/province [87] 0 0
Shaanxi
Country [88] 0 0
China
State/province [88] 0 0
Sichuan
Country [89] 0 0
China
State/province [89] 0 0
Beijing
Country [90] 0 0
China
State/province [90] 0 0
Chongqing
Country [91] 0 0
China
State/province [91] 0 0
Shanghai
Country [92] 0 0
Colombia
State/province [92] 0 0
Antioquia
Country [93] 0 0
Colombia
State/province [93] 0 0
Distrito Capital de Bogotá
Country [94] 0 0
Colombia
State/province [94] 0 0
Valle del Cauca
Country [95] 0 0
Colombia
State/province [95] 0 0
Bogota
Country [96] 0 0
Colombia
State/province [96] 0 0
Bogotá
Country [97] 0 0
Colombia
State/province [97] 0 0
Cali
Country [98] 0 0
Colombia
State/province [98] 0 0
Medellín
Country [99] 0 0
Croatia
State/province [99] 0 0
Osijek
Country [100] 0 0
Croatia
State/province [100] 0 0
Rijeka
Country [101] 0 0
Croatia
State/province [101] 0 0
Zadar
Country [102] 0 0
Croatia
State/province [102] 0 0
Zagreb
Country [103] 0 0
Czech Republic
State/province [103] 0 0
Brno
Country [104] 0 0
Czech Republic
State/province [104] 0 0
Kutna Hora
Country [105] 0 0
Czech Republic
State/province [105] 0 0
Nove Mesto na Morave
Country [106] 0 0
Czech Republic
State/province [106] 0 0
Olomouc
Country [107] 0 0
Czech Republic
State/province [107] 0 0
Plzen
Country [108] 0 0
Czech Republic
State/province [108] 0 0
Praha 2
Country [109] 0 0
Czech Republic
State/province [109] 0 0
Ricany
Country [110] 0 0
Czech Republic
State/province [110] 0 0
Znojmo
Country [111] 0 0
Denmark
State/province [111] 0 0
Esbjerg
Country [112] 0 0
Denmark
State/province [112] 0 0
Frederiksberg C
Country [113] 0 0
Denmark
State/province [113] 0 0
Kolding
Country [114] 0 0
Denmark
State/province [114] 0 0
København NV
Country [115] 0 0
Denmark
State/province [115] 0 0
København S
Country [116] 0 0
Denmark
State/province [116] 0 0
Roskilde
Country [117] 0 0
Estonia
State/province [117] 0 0
Tallinn
Country [118] 0 0
Estonia
State/province [118] 0 0
Tartu
Country [119] 0 0
Finland
State/province [119] 0 0
Helsinki
Country [120] 0 0
Finland
State/province [120] 0 0
Hämeenlinna
Country [121] 0 0
Finland
State/province [121] 0 0
Jyväskylä
Country [122] 0 0
Finland
State/province [122] 0 0
Lahti
Country [123] 0 0
Finland
State/province [123] 0 0
Lappeenranta
Country [124] 0 0
Finland
State/province [124] 0 0
Raisio
Country [125] 0 0
Finland
State/province [125] 0 0
Turku
Country [126] 0 0
France
State/province [126] 0 0
Arras
Country [127] 0 0
France
State/province [127] 0 0
Besancon
Country [128] 0 0
France
State/province [128] 0 0
Brest Cedex
Country [129] 0 0
France
State/province [129] 0 0
Castelnau Le Lez
Country [130] 0 0
France
State/province [130] 0 0
Clermont Ferrand
Country [131] 0 0
France
State/province [131] 0 0
Colombes Cedex
Country [132] 0 0
France
State/province [132] 0 0
Dijon
Country [133] 0 0
France
State/province [133] 0 0
Lille
Country [134] 0 0
France
State/province [134] 0 0
Limoges
Country [135] 0 0
France
State/province [135] 0 0
Lomme
Country [136] 0 0
France
State/province [136] 0 0
Lyon
Country [137] 0 0
France
State/province [137] 0 0
Montpellier Cedex
Country [138] 0 0
France
State/province [138] 0 0
Nice
Country [139] 0 0
France
State/province [139] 0 0
Nimes
Country [140] 0 0
France
State/province [140] 0 0
Paris
Country [141] 0 0
France
State/province [141] 0 0
Pierre Benite
Country [142] 0 0
France
State/province [142] 0 0
Reims
Country [143] 0 0
France
State/province [143] 0 0
Roubaix
Country [144] 0 0
France
State/province [144] 0 0
Saint Herblain Cedex
Country [145] 0 0
France
State/province [145] 0 0
Saint-etienne
Country [146] 0 0
France
State/province [146] 0 0
Strasbourg Cedex
Country [147] 0 0
France
State/province [147] 0 0
Toulouse
Country [148] 0 0
France
State/province [148] 0 0
TOURCOING cedex
Country [149] 0 0
France
State/province [149] 0 0
Vandoeuvre Les Nancy
Country [150] 0 0
Germany
State/province [150] 0 0
Baden-Württemberg
Country [151] 0 0
Germany
State/province [151] 0 0
Bayern
Country [152] 0 0
Germany
State/province [152] 0 0
Brandenburg
Country [153] 0 0
Germany
State/province [153] 0 0
Nordrhein-Westfalen
Country [154] 0 0
Germany
State/province [154] 0 0
Rheinland-Pfalz
Country [155] 0 0
Germany
State/province [155] 0 0
Sachsen-Anhalt
Country [156] 0 0
Germany
State/province [156] 0 0
Sachsen
Country [157] 0 0
Germany
State/province [157] 0 0
Berlin
Country [158] 0 0
Germany
State/province [158] 0 0
Bremen
Country [159] 0 0
Greece
State/province [159] 0 0
Attica
Country [160] 0 0
Greece
State/province [160] 0 0
Abelokipi - Athens
Country [161] 0 0
Greece
State/province [161] 0 0
Athens
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Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in
the leg and lung that can occur with patients hospitalized for acute medical illness, and
compare these results with those of the standard enoxaparin dose and duration regimen. The
safety of rivaroxaban will also be studied.
Trial website
https://clinicaltrials.gov/show/NCT00571649
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
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
Other publications