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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00440193




Registration number
NCT00440193
Ethics application status
Date submitted
23/02/2007
Date registered
26/02/2007
Date last updated
27/02/2014

Titles & IDs
Public title
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis - The EINSTEIN DVT Study
Scientific title
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism
Secondary ID [1] 0 0
2006-004495-13
Secondary ID [2] 0 0
11702a
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thrombosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases
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 followed by VKA

Experimental: Rivaroxaban (Xarelto, BAY59-7939) - Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily

Active Comparator: Enoxaparin/VKA - Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)


Treatment: Drugs: Rivaroxaban (Xarelto, BAY59-7939)
During the first 3 weeks patients will receive 15 mg rivaroxaban twice-daily. Thereafter, patients will receive rivaroxaban 20 mg once-daily. Rivaroxaban will be administered orally and should be taken with food.

Treatment: Drugs: Enoxaparin followed by VKA
Enoxaparin 1.0 mg/kg twice daily with a minimal duration of 5 days. This 5 days treatment could include the period up to 36 h before randomization if enoxaparin twice-daily was used. VKA should be started as soon as possible but not later than 48 hours after randomization.

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

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment - All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries.
Timepoint [1] 0 0
3-, 6- or 12-month study treatment period
Secondary outcome [1] 0 0
Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment - All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.
Timepoint [1] 0 0
3-, 6- or 12-month study treatment period
Secondary outcome [2] 0 0
Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment - Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of =2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.
Timepoint [2] 0 0
3-, 6- or 12-month study treatment period
Secondary outcome [3] 0 0
Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment - All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.
Timepoint [3] 0 0
3-, 6- or 12-month study treatment period
Secondary outcome [4] 0 0
Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose) - All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life.
Timepoint [4] 0 0
3-, 6- or 12-month study treatment period
Secondary outcome [5] 0 0
Percentage of Participants With All Deaths - All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries.
Timepoint [5] 0 0
3-, 6- or 12-month study treatment period
Secondary outcome [6] 0 0
Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose) - All pre-defined vascular events (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, unstable angina, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism or vascular death) were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based results/films/images of confirmatory testing, and/or case summaries.
Timepoint [6] 0 0
3-, 6- or 12-month study treatment period

Eligibility
Key inclusion criteria
- Confirmed acute symptomatic proximal DVT without symptomatic PE
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Legal lower age limitations (country specific)

- Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the
current episode of DVT and/or PE

- Other indication for VKA than DVT and/or PE

- The pre-randomization anti-coagulant treatment (Criteria # 4) has been prolonged from
36 hours to a maximum of 48 hours.

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



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,VIC,WA
Recruitment hospital [1] 0 0
- Garran
Recruitment hospital [2] 0 0
- Darlinghurst
Recruitment hospital [3] 0 0
- Gosford
Recruitment hospital [4] 0 0
- Kogarah
Recruitment hospital [5] 0 0
- Lismore
Recruitment hospital [6] 0 0
- St Leonards
Recruitment hospital [7] 0 0
- Sydney
Recruitment hospital [8] 0 0
- Brisbane
Recruitment hospital [9] 0 0
- Redcliffe
Recruitment hospital [10] 0 0
- Southport
Recruitment hospital [11] 0 0
- Woolloongabba
Recruitment hospital [12] 0 0
- Adelaide
Recruitment hospital [13] 0 0
- Woodville South
Recruitment hospital [14] 0 0
- Box Hill
Recruitment hospital [15] 0 0
- Clayton
Recruitment hospital [16] 0 0
- Geelong
Recruitment hospital [17] 0 0
- Melbourne
Recruitment hospital [18] 0 0
- Fremantle
Recruitment hospital [19] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2250 - Gosford
Recruitment postcode(s) [4] 0 0
2217 - Kogarah
Recruitment postcode(s) [5] 0 0
2480 - Lismore
Recruitment postcode(s) [6] 0 0
2065 - St Leonards
Recruitment postcode(s) [7] 0 0
2031 - Sydney
Recruitment postcode(s) [8] 0 0
2139 - Sydney
Recruitment postcode(s) [9] 0 0
2229 - Sydney
Recruitment postcode(s) [10] 0 0
4029 - Brisbane
Recruitment postcode(s) [11] 0 0
4020 - Redcliffe
Recruitment postcode(s) [12] 0 0
4215 - Southport
Recruitment postcode(s) [13] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [14] 0 0
5042 - Adelaide
Recruitment postcode(s) [15] 0 0
5011 - Woodville South
Recruitment postcode(s) [16] 0 0
3128 - Box Hill
Recruitment postcode(s) [17] 0 0
3168 - Clayton
Recruitment postcode(s) [18] 0 0
3220 - Geelong
Recruitment postcode(s) [19] 0 0
3135 - Melbourne
Recruitment postcode(s) [20] 0 0
3181 - Melbourne
Recruitment postcode(s) [21] 0 0
6160 - Fremantle
Recruitment postcode(s) [22] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Idaho
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
New Mexico
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Utah
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Austria
State/province [16] 0 0
Steiermark
Country [17] 0 0
Austria
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Vorarlberg
Country [18] 0 0
Austria
State/province [18] 0 0
Innsbruck
Country [19] 0 0
Austria
State/province [19] 0 0
Salzburg
Country [20] 0 0
Austria
State/province [20] 0 0
Wien
Country [21] 0 0
Belgium
State/province [21] 0 0
Bruxelles - Brussel
Country [22] 0 0
Belgium
State/province [22] 0 0
Duffel
Country [23] 0 0
Belgium
State/province [23] 0 0
Genk
Country [24] 0 0
Belgium
State/province [24] 0 0
Gent
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Belgium
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Hasselt
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Belgium
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Leuven
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Belgium
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Liege
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Belgium
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Lier
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Belgium
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Namur
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Belgium
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Yvoir
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Belgium
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Zottegem
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Brazil
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Minas Gerais
Country [33] 0 0
Brazil
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Parana
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Brazil
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Sao Paulo
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Brazil
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SP
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Brazil
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Rio de Janeiro
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Canada
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Manitoba
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Ontario
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Guangdong
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Heilongjiang
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Hubei
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China
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Jiangsu
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China
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Liaoning
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China
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Zhejiang
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China
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Beijing
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China
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Shanghai
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Czech Republic
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Karlovy Vary
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Czech Republic
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Kladno
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Czech Republic
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Ostrava-Poruba
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Czech Republic
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Ostrava
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Czech Republic
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Prague 5
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Czech Republic
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Prague
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Czech Republic
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Praha 1
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Czech Republic
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Praha 2
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Czech Republic
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Usti nad Lebem
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Denmark
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Aarhus C
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Braedstrup
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Frederiksberg
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Hellerup
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Amiens
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Arras
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Besancon
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Bordeaux
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Brest Cedex
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Castelnau Le Lez
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Clamart
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Clermont Ferrand
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Creteil
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Dijon
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Grenoble
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Lille Cedex
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Limoges
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France
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Metz-tessy
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France
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Montpellier Cedex
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France
State/province [79] 0 0
Nantes
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Nice
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Nimes Cedex 9
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France
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Orthez
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France
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Paris Cedex 15
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France
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Paris
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Pierre Benite
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France
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Roanne
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France
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Rouen Cedex
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France
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Saint Etienne
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France
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Strasbourg Cedex
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France
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Toulon
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France
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Toulouse
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France
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Tours
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France
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Valenciennes Cedex
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France
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Vandoeuvre Les Nancy
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France
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Vernon
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Germany
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Baden-Württemberg
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Germany
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Bayern
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Germany
State/province [98] 0 0
Hessen
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Germany
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Mecklenburg-Vorpommern
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
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Rheinland-Pfalz
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Germany
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Saarland
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Germany
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Sachsen-Anhalt
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Germany
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Sachsen
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Germany
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Berlin
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Germany
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Hamburg
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Hong Kong
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Hong Kong
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Hong Kong
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Wanchai
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Kecskemet
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Hungary
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Kistarcsa
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Hungary
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Miskolc
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Hungary
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Szentes
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Hungary
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Szombathely
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India
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Kerala
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India
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Maharashtra
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India
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Hyderabad
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India
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Kolkata
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India
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New Delhi
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India
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Pune
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Indonesia
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Bandung
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Indonesia
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Jakarta
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Indonesia
State/province [125] 0 0
Medan
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Indonesia
State/province [126] 0 0
Semarang
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Israel
State/province [127] 0 0
Afula
Country [128] 0 0
Israel
State/province [128] 0 0
Ashkelon
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Israel
State/province [129] 0 0
Beer Sheva
Country [130] 0 0
Israel
State/province [130] 0 0
Haifa
Country [131] 0 0
Israel
State/province [131] 0 0
Holon
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Petach Tikva
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Israel
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Rehovot
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Israel
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Safed
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Israel
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Tel Aviv
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Italy
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Bologna
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Italy
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Chieti
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Italy
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Cremona
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Italy
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Milano
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Italy
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Napoli
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Italy
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Padova
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Italy
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Palermo
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Italy
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Parma
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Italy
State/province [146] 0 0
Pavia
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Italy
State/province [147] 0 0
Piacenza
Country [148] 0 0
Italy
State/province [148] 0 0
Reggio Emilia
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Italy
State/province [149] 0 0
Varese
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Italy
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Venezia
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Korea, Republic of
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Korea
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Korea, Republic of
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Daegu
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Korea, Republic of
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Korea, Republic of
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Taegu
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Malaysia
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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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Dordrecht
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Netherlands
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Enschede
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Netherlands
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Groningen
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Netherlands
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Hoofddorp
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Maastricht
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Netherlands
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Rotterdam
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Netherlands
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Zwijndrecht
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Netherlands
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Zwolle
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New Zealand
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Auckland
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New Zealand
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Christchurch
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New Zealand
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Palmerston North
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New Zealand
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Wellington South
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Norway
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Fredrikstad
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Norway
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Oslo
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Norway
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Rud
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Norway
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Trondheim
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Philippines
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Quezon City
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Bialystok
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Bydgoszcz
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Gdansk
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Katowice
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Krakow
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Lodz
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Lublin
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Poznan
Country [183] 0 0
Poland
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Torun
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Country [186] 0 0
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Country [187] 0 0
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Singapore
Country [188] 0 0
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State/province [188] 0 0
Cape
Country [189] 0 0
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State/province [189] 0 0
Gauteng
Country [190] 0 0
South Africa
State/province [190] 0 0
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Country [191] 0 0
Spain
State/province [191] 0 0
Barcelona
Country [192] 0 0
Spain
State/province [192] 0 0
Madrid
Country [193] 0 0
Spain
State/province [193] 0 0
Valencia
Country [194] 0 0
Spain
State/province [194] 0 0
Girona
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Spain
State/province [195] 0 0
Pamplona
Country [196] 0 0
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State/province [196] 0 0
Borås
Country [197] 0 0
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State/province [197] 0 0
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Country [198] 0 0
Sweden
State/province [198] 0 0
Jönköping
Country [199] 0 0
Sweden
State/province [199] 0 0
Sundsvall
Country [200] 0 0
Sweden
State/province [200] 0 0
Västervik
Country [201] 0 0
Switzerland
State/province [201] 0 0
Genève 14
Country [202] 0 0
Switzerland
State/province [202] 0 0
Graubünden
Country [203] 0 0
Switzerland
State/province [203] 0 0
Waadt
Country [204] 0 0
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State/province [204] 0 0
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Country [205] 0 0
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Thailand
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Pathumwan, Bangkok
Country [211] 0 0
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State/province [211] 0 0
Devon
Country [212] 0 0
United Kingdom
State/province [212] 0 0
Essex
Country [213] 0 0
United Kingdom
State/province [213] 0 0
Greater London
Country [214] 0 0
United Kingdom
State/province [214] 0 0
London

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 is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority
program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with
confirmed acute symptomatic DVT without symptomatic PE (Einstein-DVT).
Trial website
https://clinicaltrials.gov/show/NCT00440193
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