Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00439725
Registration number
NCT00439725
Ethics application status
Date submitted
23/02/2007
Date registered
26/02/2007
Date last updated
4/11/2014
Titles & IDs
Public title
Once - Daily Oral Direct Factor Xa Inhibitor Rivaroxaban In The Long-Term Prevention Of Recurrent Symptomatic Venous Thromboembolism In Patients With Symptomatic Deep-Vein Thrombosis Or Pulmonary Embolism. The Einstein-Extension Study
Query!
Scientific title
Once-daily Oral Direct Factor Xa Inhibitor Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis or Pulmonary Embolism. The Einstein-Extension Study
Query!
Secondary ID [1]
0
0
2006-004494-96
Query!
Secondary ID [2]
0
0
11899
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Diseases of the vasculature and circulation including the lymphatic system
Query!
Blood
0
0
0
0
Query!
Clotting disorders
Query!
Respiratory
0
0
0
0
Query!
Other respiratory disorders / diseases
Query!
Cardiovascular
0
0
0
0
Query!
Other cardiovascular diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Rivaroxaban (Xarelto, BAY59-7939)
Treatment: Drugs - Placebo
Experimental: Rivaroxaban (Xarelto, BAY59-7939) - Participants were to receive rivaroxaban 20 mg oral tablet once daily
Placebo comparator: Placebo - Participants were to receive matching placebo oral tablet once daily
Treatment: Drugs: Rivaroxaban (Xarelto, BAY59-7939)
Patients randomized to rivaroxaban will receive rivaroxaban 20 mg once-daily.
Treatment: Drugs: Placebo
Patients allocated to placebo will receive a matching placebo tablet once daily.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
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
Query!
Assessment method [1]
0
0
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. For definition of DVT/PE, kindly refer to the link in the Protocol section.
Query!
Timepoint [1]
0
0
6- or 12-month study treatment period
Query!
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
Query!
Assessment method [1]
0
0
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), or lung scintigraphy (for PE), and/or case summaries.
Query!
Timepoint [1]
0
0
6- or 12-month study treatment period
Query!
Secondary outcome [2]
0
0
Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE, All Cause Mortality, Strokes and Myocardial Infarctions Until the Intended End of Study Treatment
Query!
Assessment method [2]
0
0
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), results/films/images of confirmatory testing, and/or case summaries.
Query!
Timepoint [2]
0
0
6- or 12-month study treatment period
Query!
Secondary outcome [3]
0
0
Percentage of Participants With Net Clinical Benefit as Composite of Recurrent DVT or Non-fatal or Fatal PE and Major Bleeding Events Until the Intended End of Study Treatment
Query!
Assessment method [3]
0
0
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. 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.
Query!
Timepoint [3]
0
0
6- or 12-month study treatment period
Query!
Secondary outcome [4]
0
0
Percentage of Participants With Recurrent VTE (PE or DVT) Until the Intended End of Study Treatment
Query!
Assessment method [4]
0
0
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), results/films/images of confirmatory testing, and/or case summaries.
Query!
Timepoint [4]
0
0
6- or 12-month study treatment period
Query!
Secondary outcome [5]
0
0
Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
6- or 12-month study treatment period
Query!
Secondary outcome [6]
0
0
Percentage of Participants With Major Bleeding
Query!
Assessment method [6]
0
0
All events were adjudicated and confirmed by a central independent adjudication committee (CIAC) blinded to treatment. Major bleeding event was overt bleeding associated with a 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. Treatment-emergent \[after intake of first tablet of study medication as randomized but not more than 2 days after stop of study medication (referred to as time window: 2 days)\] events and all events post randomization were reported.
Query!
Timepoint [6]
0
0
6- or 12-month study treatment period
Query!
Secondary outcome [7]
0
0
Percentage of Participants With Clinically Relevant Bleeding
Query!
Assessment method [7]
0
0
All events adjudicated/confirmed by CIAC blinded to treatment. Clinically relevant bleeding included major bleeding (definition: see outcome 7) 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 daily life activities. Treatment-emergent events (after intake of 1st study medication tablet as randomized up to 2 days after stop of study medication \['time window: 2 days'\]) and all events post randomization were reported
Query!
Timepoint [7]
0
0
6- or 12-month study treatment period
Query!
Secondary outcome [8]
0
0
Percentage of Participants With All Death
Query!
Assessment method [8]
0
0
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. Treatment-emergent events and all events post randomization were reported. Treatment-emergent: after intake of first tablet of study medication as randomized but not more than 2 days after stop of study medication (referred to as time window: 2 days)
Query!
Timepoint [8]
0
0
6- or 12-month study treatment period
Query!
Secondary outcome [9]
0
0
Percentage of Participants With Other Vascular Events
Query!
Assessment method [9]
0
0
All pre-defined vascular events (acute coronary syndromes, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism and vascular death) were adjudicated/confirmed by a central independent adjudication committee blinded to treatment, based on results/films/images of confirmatory testing, and/or case summaries. On treatment events and all events post randomization were reported. On treatment: after intake of first tablet of study medication as randomized but not more than 1 day after stop of study medication (referred to as time window: 1 day)
Query!
Timepoint [9]
0
0
6- or 12-month study treatment period
Query!
Eligibility
Key inclusion criteria
* Patients with confirmed symptomatic PE or DVT who have been treated for 6 or 12 months with VKA or rivaroxaban
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Legal lower age limitations (country specific)
* Indication for VKA other than DVT and/or PE
* Patients in whom anticoagulant treatment for their index PE or DVT should be continued
* Childbearing potential without proper contraceptive measures, pregnancy or breast feeding. Proper contraceptive measures are defined as a method of contraception with a failure rate < 1 % during the course of the study (including the observational period). These methods of contraception according to the note for guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP [Committee for Proprietary Medicinal Products]/ICH [International Conference on Harmonization]/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/02/2007
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/09/2009
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1197
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
- Garran
Query!
Recruitment hospital [2]
0
0
- Gosford
Query!
Recruitment hospital [3]
0
0
- Kogarah
Query!
Recruitment hospital [4]
0
0
- Lismore
Query!
Recruitment hospital [5]
0
0
- St Leonards
Query!
Recruitment hospital [6]
0
0
- Sydney
Query!
Recruitment hospital [7]
0
0
- Brisbane
Query!
Recruitment hospital [8]
0
0
- Redcliffe
Query!
Recruitment hospital [9]
0
0
- Southport
Query!
Recruitment hospital [10]
0
0
- Woolloongabba
Query!
Recruitment hospital [11]
0
0
- Adelaide
Query!
Recruitment hospital [12]
0
0
- Box Hill
Query!
Recruitment hospital [13]
0
0
- Clayton
Query!
Recruitment hospital [14]
0
0
- Geelong
Query!
Recruitment hospital [15]
0
0
- Melbourne
Query!
Recruitment hospital [16]
0
0
- Prahran
Query!
Recruitment hospital [17]
0
0
- Fremantle
Query!
Recruitment hospital [18]
0
0
- Perth
Query!
Recruitment postcode(s) [1]
0
0
2605 - Garran
Query!
Recruitment postcode(s) [2]
0
0
2250 - Gosford
Query!
Recruitment postcode(s) [3]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [4]
0
0
2480 - Lismore
Query!
Recruitment postcode(s) [5]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [6]
0
0
2010 - Sydney
Query!
Recruitment postcode(s) [7]
0
0
2031 - Sydney
Query!
Recruitment postcode(s) [8]
0
0
2139 - Sydney
Query!
Recruitment postcode(s) [9]
0
0
2229 - Sydney
Query!
Recruitment postcode(s) [10]
0
0
4029 - Brisbane
Query!
Recruitment postcode(s) [11]
0
0
4020 - Redcliffe
Query!
Recruitment postcode(s) [12]
0
0
4215 - Southport
Query!
Recruitment postcode(s) [13]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [14]
0
0
5011 - Adelaide
Query!
Recruitment postcode(s) [15]
0
0
5042 - Adelaide
Query!
Recruitment postcode(s) [16]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [17]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [18]
0
0
3220 - Geelong
Query!
Recruitment postcode(s) [19]
0
0
3135 - Melbourne
Query!
Recruitment postcode(s) [20]
0
0
3181 - Melbourne
Query!
Recruitment postcode(s) [21]
0
0
3181 - Prahran
Query!
Recruitment postcode(s) [22]
0
0
6160 - Fremantle
Query!
Recruitment postcode(s) [23]
0
0
6000 - Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arkansas
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Georgia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Idaho
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Louisiana
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Maryland
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Massachusetts
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
New Mexico
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
North Carolina
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Oklahoma
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Pennsylvania
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Texas
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Utah
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Vermont
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Virginia
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Washington
Query!
Country [18]
0
0
Austria
Query!
State/province [18]
0
0
Steiermark
Query!
Country [19]
0
0
Austria
Query!
State/province [19]
0
0
Tirol
Query!
Country [20]
0
0
Austria
Query!
State/province [20]
0
0
Vorarlberg
Query!
Country [21]
0
0
Austria
Query!
State/province [21]
0
0
Salzburg
Query!
Country [22]
0
0
Austria
Query!
State/province [22]
0
0
Wien
Query!
Country [23]
0
0
Belgium
Query!
State/province [23]
0
0
Bruxelles - Brussel
Query!
Country [24]
0
0
Belgium
Query!
State/province [24]
0
0
Duffel
Query!
Country [25]
0
0
Belgium
Query!
State/province [25]
0
0
Genk
Query!
Country [26]
0
0
Belgium
Query!
State/province [26]
0
0
Gent
Query!
Country [27]
0
0
Belgium
Query!
State/province [27]
0
0
Hasselt
Query!
Country [28]
0
0
Belgium
Query!
State/province [28]
0
0
Leuven
Query!
Country [29]
0
0
Belgium
Query!
State/province [29]
0
0
Liege
Query!
Country [30]
0
0
Belgium
Query!
State/province [30]
0
0
Lier
Query!
Country [31]
0
0
Belgium
Query!
State/province [31]
0
0
Namur
Query!
Country [32]
0
0
Belgium
Query!
State/province [32]
0
0
Sint-Truiden
Query!
Country [33]
0
0
Belgium
Query!
State/province [33]
0
0
Yvoir
Query!
Country [34]
0
0
Belgium
Query!
State/province [34]
0
0
Zottegem
Query!
Country [35]
0
0
Brazil
Query!
State/province [35]
0
0
Minas Gerais
Query!
Country [36]
0
0
Brazil
Query!
State/province [36]
0
0
Parana
Query!
Country [37]
0
0
Brazil
Query!
State/province [37]
0
0
Rio Grande do Sul
Query!
Country [38]
0
0
Brazil
Query!
State/province [38]
0
0
Sao Paulo
Query!
Country [39]
0
0
Brazil
Query!
State/province [39]
0
0
Rio de Janeiro
Query!
Country [40]
0
0
Canada
Query!
State/province [40]
0
0
Manitoba
Query!
Country [41]
0
0
Canada
Query!
State/province [41]
0
0
Ontario
Query!
Country [42]
0
0
China
Query!
State/province [42]
0
0
Guangdong
Query!
Country [43]
0
0
China
Query!
State/province [43]
0
0
Heilongjiang
Query!
Country [44]
0
0
China
Query!
State/province [44]
0
0
Hubei
Query!
Country [45]
0
0
China
Query!
State/province [45]
0
0
Jiangsu
Query!
Country [46]
0
0
China
Query!
State/province [46]
0
0
Liaoning
Query!
Country [47]
0
0
China
Query!
State/province [47]
0
0
Beijing
Query!
Country [48]
0
0
China
Query!
State/province [48]
0
0
Shanghai
Query!
Country [49]
0
0
Czech Republic
Query!
State/province [49]
0
0
Brno
Query!
Country [50]
0
0
Czech Republic
Query!
State/province [50]
0
0
Karlovy Vary
Query!
Country [51]
0
0
Czech Republic
Query!
State/province [51]
0
0
Kladno
Query!
Country [52]
0
0
Czech Republic
Query!
State/province [52]
0
0
Ostrava-Poruba
Query!
Country [53]
0
0
Czech Republic
Query!
State/province [53]
0
0
Ostrava
Query!
Country [54]
0
0
Czech Republic
Query!
State/province [54]
0
0
Prague 5
Query!
Country [55]
0
0
Czech Republic
Query!
State/province [55]
0
0
Praha 1
Query!
Country [56]
0
0
Czech Republic
Query!
State/province [56]
0
0
Praha 2
Query!
Country [57]
0
0
Czech Republic
Query!
State/province [57]
0
0
Praha 4
Query!
Country [58]
0
0
Czech Republic
Query!
State/province [58]
0
0
Usti nad Lebem
Query!
Country [59]
0
0
Denmark
Query!
State/province [59]
0
0
Aarhus C
Query!
Country [60]
0
0
Denmark
Query!
State/province [60]
0
0
Braedstrup
Query!
Country [61]
0
0
Denmark
Query!
State/province [61]
0
0
Frederiksberg
Query!
Country [62]
0
0
Denmark
Query!
State/province [62]
0
0
Hellerup
Query!
Country [63]
0
0
Finland
Query!
State/province [63]
0
0
Seinäjoki
Query!
Country [64]
0
0
France
Query!
State/province [64]
0
0
Agen Cedex 9
Query!
Country [65]
0
0
France
Query!
State/province [65]
0
0
Amiens
Query!
Country [66]
0
0
France
Query!
State/province [66]
0
0
Angers Cedex 01
Query!
Country [67]
0
0
France
Query!
State/province [67]
0
0
Arras
Query!
Country [68]
0
0
France
Query!
State/province [68]
0
0
Bordeaux
Query!
Country [69]
0
0
France
Query!
State/province [69]
0
0
Brest Cedex
Query!
Country [70]
0
0
France
Query!
State/province [70]
0
0
Castelnau Le Lez
Query!
Country [71]
0
0
France
Query!
State/province [71]
0
0
Clamart
Query!
Country [72]
0
0
France
Query!
State/province [72]
0
0
Clermont Ferrand
Query!
Country [73]
0
0
France
Query!
State/province [73]
0
0
Colombes
Query!
Country [74]
0
0
France
Query!
State/province [74]
0
0
Creteil
Query!
Country [75]
0
0
France
Query!
State/province [75]
0
0
Dijon
Query!
Country [76]
0
0
France
Query!
State/province [76]
0
0
Grenoble
Query!
Country [77]
0
0
France
Query!
State/province [77]
0
0
Lille Cedex
Query!
Country [78]
0
0
France
Query!
State/province [78]
0
0
Limoges
Query!
Country [79]
0
0
France
Query!
State/province [79]
0
0
Montpellier Cedex
Query!
Country [80]
0
0
France
Query!
State/province [80]
0
0
Nantes
Query!
Country [81]
0
0
France
Query!
State/province [81]
0
0
Nimes Cedex 9
Query!
Country [82]
0
0
France
Query!
State/province [82]
0
0
Orthez
Query!
Country [83]
0
0
France
Query!
State/province [83]
0
0
Paris Cedex 15
Query!
Country [84]
0
0
France
Query!
State/province [84]
0
0
Paris
Query!
Country [85]
0
0
France
Query!
State/province [85]
0
0
Pierre Benite
Query!
Country [86]
0
0
France
Query!
State/province [86]
0
0
Roanne
Query!
Country [87]
0
0
France
Query!
State/province [87]
0
0
Rouen Cedex
Query!
Country [88]
0
0
France
Query!
State/province [88]
0
0
Saint Etienne
Query!
Country [89]
0
0
France
Query!
State/province [89]
0
0
Strasbourg Cedex
Query!
Country [90]
0
0
France
Query!
State/province [90]
0
0
Toulon
Query!
Country [91]
0
0
France
Query!
State/province [91]
0
0
Toulouse
Query!
Country [92]
0
0
France
Query!
State/province [92]
0
0
Tours
Query!
Country [93]
0
0
France
Query!
State/province [93]
0
0
Valenciennes Cedex
Query!
Country [94]
0
0
France
Query!
State/province [94]
0
0
Vandoeuvre Les Nancy
Query!
Country [95]
0
0
France
Query!
State/province [95]
0
0
Vernon
Query!
Country [96]
0
0
Germany
Query!
State/province [96]
0
0
Baden-Württemberg
Query!
Country [97]
0
0
Germany
Query!
State/province [97]
0
0
Bayern
Query!
Country [98]
0
0
Germany
Query!
State/province [98]
0
0
Hessen
Query!
Country [99]
0
0
Germany
Query!
State/province [99]
0
0
Mecklenburg-Vorpommern
Query!
Country [100]
0
0
Germany
Query!
State/province [100]
0
0
Niedersachsen
Query!
Country [101]
0
0
Germany
Query!
State/province [101]
0
0
Nordrhein-Westfalen
Query!
Country [102]
0
0
Germany
Query!
State/province [102]
0
0
Rheinland-Pfalz
Query!
Country [103]
0
0
Germany
Query!
State/province [103]
0
0
Saarland
Query!
Country [104]
0
0
Germany
Query!
State/province [104]
0
0
Sachsen-Anhalt
Query!
Country [105]
0
0
Germany
Query!
State/province [105]
0
0
Sachsen
Query!
Country [106]
0
0
Germany
Query!
State/province [106]
0
0
Berlin
Query!
Country [107]
0
0
Germany
Query!
State/province [107]
0
0
Hamburg
Query!
Country [108]
0
0
Hong Kong
Query!
State/province [108]
0
0
Hong Kong
Query!
Country [109]
0
0
Hungary
Query!
State/province [109]
0
0
Budapest
Query!
Country [110]
0
0
Hungary
Query!
State/province [110]
0
0
Debrecen
Query!
Country [111]
0
0
Hungary
Query!
State/province [111]
0
0
Kecskemet
Query!
Country [112]
0
0
Hungary
Query!
State/province [112]
0
0
Kistarcsa
Query!
Country [113]
0
0
Hungary
Query!
State/province [113]
0
0
Miskolc
Query!
Country [114]
0
0
Hungary
Query!
State/province [114]
0
0
Nyiregyhaza
Query!
Country [115]
0
0
Hungary
Query!
State/province [115]
0
0
Szentes
Query!
Country [116]
0
0
Hungary
Query!
State/province [116]
0
0
Szombathely
Query!
Country [117]
0
0
India
Query!
State/province [117]
0
0
Kerala
Query!
Country [118]
0
0
India
Query!
State/province [118]
0
0
Maharashtra
Query!
Country [119]
0
0
India
Query!
State/province [119]
0
0
Hyderabad
Query!
Country [120]
0
0
India
Query!
State/province [120]
0
0
Kolkata
Query!
Country [121]
0
0
India
Query!
State/province [121]
0
0
New Delhi
Query!
Country [122]
0
0
India
Query!
State/province [122]
0
0
Pune
Query!
Country [123]
0
0
Indonesia
Query!
State/province [123]
0
0
Bandung
Query!
Country [124]
0
0
Indonesia
Query!
State/province [124]
0
0
Jakarta
Query!
Country [125]
0
0
Indonesia
Query!
State/province [125]
0
0
Medan
Query!
Country [126]
0
0
Indonesia
Query!
State/province [126]
0
0
Semarang
Query!
Country [127]
0
0
Israel
Query!
State/province [127]
0
0
Afula
Query!
Country [128]
0
0
Israel
Query!
State/province [128]
0
0
Ashkelon
Query!
Country [129]
0
0
Israel
Query!
State/province [129]
0
0
Beer Sheva
Query!
Country [130]
0
0
Israel
Query!
State/province [130]
0
0
Haifa
Query!
Country [131]
0
0
Israel
Query!
State/province [131]
0
0
Holon
Query!
Country [132]
0
0
Israel
Query!
State/province [132]
0
0
Jerusalem
Query!
Country [133]
0
0
Israel
Query!
State/province [133]
0
0
Kfar Saba
Query!
Country [134]
0
0
Israel
Query!
State/province [134]
0
0
Petach Tikva
Query!
Country [135]
0
0
Israel
Query!
State/province [135]
0
0
Rehovot
Query!
Country [136]
0
0
Israel
Query!
State/province [136]
0
0
Safed
Query!
Country [137]
0
0
Israel
Query!
State/province [137]
0
0
Tel Aviv
Query!
Country [138]
0
0
Italy
Query!
State/province [138]
0
0
Bologna
Query!
Country [139]
0
0
Italy
Query!
State/province [139]
0
0
Chieti
Query!
Country [140]
0
0
Italy
Query!
State/province [140]
0
0
Milano
Query!
Country [141]
0
0
Italy
Query!
State/province [141]
0
0
Napoli
Query!
Country [142]
0
0
Italy
Query!
State/province [142]
0
0
Padova
Query!
Country [143]
0
0
Italy
Query!
State/province [143]
0
0
Palermo
Query!
Country [144]
0
0
Italy
Query!
State/province [144]
0
0
Parma
Query!
Country [145]
0
0
Italy
Query!
State/province [145]
0
0
Pavia
Query!
Country [146]
0
0
Italy
Query!
State/province [146]
0
0
Piacenza
Query!
Country [147]
0
0
Italy
Query!
State/province [147]
0
0
Venezia
Query!
Country [148]
0
0
Korea, Republic of
Query!
State/province [148]
0
0
Daegu Gwang'yeogsi
Query!
Country [149]
0
0
Korea, Republic of
Query!
State/province [149]
0
0
Seoul Teugbyeolsi
Query!
Country [150]
0
0
Korea, Republic of
Query!
State/province [150]
0
0
Daegu
Query!
Country [151]
0
0
Korea, Republic of
Query!
State/province [151]
0
0
Seoul
Query!
Country [152]
0
0
Korea, Republic of
Query!
State/province [152]
0
0
Taegu
Query!
Country [153]
0
0
Malaysia
Query!
State/province [153]
0
0
Selangor
Query!
Country [154]
0
0
Netherlands
Query!
State/province [154]
0
0
Amsterdam
Query!
Country [155]
0
0
Netherlands
Query!
State/province [155]
0
0
Arnhem
Query!
Country [156]
0
0
Netherlands
Query!
State/province [156]
0
0
Den Bosch
Query!
Country [157]
0
0
Netherlands
Query!
State/province [157]
0
0
Dordrecht
Query!
Country [158]
0
0
Netherlands
Query!
State/province [158]
0
0
Enschede
Query!
Country [159]
0
0
Netherlands
Query!
State/province [159]
0
0
Groningen
Query!
Country [160]
0
0
Netherlands
Query!
State/province [160]
0
0
Hoofddorp
Query!
Country [161]
0
0
Netherlands
Query!
State/province [161]
0
0
Maastricht
Query!
Country [162]
0
0
Netherlands
Query!
State/province [162]
0
0
Rotterdam
Query!
Country [163]
0
0
Netherlands
Query!
State/province [163]
0
0
Zwijndrecht
Query!
Country [164]
0
0
Netherlands
Query!
State/province [164]
0
0
Zwolle
Query!
Country [165]
0
0
New Zealand
Query!
State/province [165]
0
0
Auckland
Query!
Country [166]
0
0
New Zealand
Query!
State/province [166]
0
0
Christchurch
Query!
Country [167]
0
0
New Zealand
Query!
State/province [167]
0
0
Palmerston North
Query!
Country [168]
0
0
New Zealand
Query!
State/province [168]
0
0
Wellington South
Query!
Country [169]
0
0
Norway
Query!
State/province [169]
0
0
Fredrikstad
Query!
Country [170]
0
0
Norway
Query!
State/province [170]
0
0
Oslo
Query!
Country [171]
0
0
Norway
Query!
State/province [171]
0
0
Rud
Query!
Country [172]
0
0
Philippines
Query!
State/province [172]
0
0
Quezon City
Query!
Country [173]
0
0
Poland
Query!
State/province [173]
0
0
Bialystok
Query!
Country [174]
0
0
Poland
Query!
State/province [174]
0
0
Bydgoszcz
Query!
Country [175]
0
0
Poland
Query!
State/province [175]
0
0
Gdansk
Query!
Country [176]
0
0
Poland
Query!
State/province [176]
0
0
Katowice
Query!
Country [177]
0
0
Poland
Query!
State/province [177]
0
0
Krakow
Query!
Country [178]
0
0
Poland
Query!
State/province [178]
0
0
Lodz
Query!
Country [179]
0
0
Poland
Query!
State/province [179]
0
0
Lublin
Query!
Country [180]
0
0
Poland
Query!
State/province [180]
0
0
Poznan
Query!
Country [181]
0
0
Poland
Query!
State/province [181]
0
0
Torun
Query!
Country [182]
0
0
Poland
Query!
State/province [182]
0
0
Warszawa
Query!
Country [183]
0
0
Poland
Query!
State/province [183]
0
0
Wroclaw
Query!
Country [184]
0
0
Singapore
Query!
State/province [184]
0
0
Singapore
Query!
Country [185]
0
0
South Africa
Query!
State/province [185]
0
0
Cape
Query!
Country [186]
0
0
South Africa
Query!
State/province [186]
0
0
Gauteng
Query!
Country [187]
0
0
South Africa
Query!
State/province [187]
0
0
Western Cape
Query!
Country [188]
0
0
Spain
Query!
State/province [188]
0
0
Barcelona
Query!
Country [189]
0
0
Spain
Query!
State/province [189]
0
0
Madrid
Query!
Country [190]
0
0
Spain
Query!
State/province [190]
0
0
Valencia
Query!
Country [191]
0
0
Spain
Query!
State/province [191]
0
0
Girona
Query!
Country [192]
0
0
Spain
Query!
State/province [192]
0
0
Pamplona
Query!
Country [193]
0
0
Sweden
Query!
State/province [193]
0
0
Borås
Query!
Country [194]
0
0
Sweden
Query!
State/province [194]
0
0
Göteborg
Query!
Country [195]
0
0
Sweden
Query!
State/province [195]
0
0
Jönköping
Query!
Country [196]
0
0
Sweden
Query!
State/province [196]
0
0
Sundsvall
Query!
Country [197]
0
0
Sweden
Query!
State/province [197]
0
0
Västervik
Query!
Country [198]
0
0
Switzerland
Query!
State/province [198]
0
0
Basel-Landschaft
Query!
Country [199]
0
0
Switzerland
Query!
State/province [199]
0
0
Genève 14
Query!
Country [200]
0
0
Switzerland
Query!
State/province [200]
0
0
Graubünden
Query!
Country [201]
0
0
Switzerland
Query!
State/province [201]
0
0
Valais
Query!
Country [202]
0
0
Switzerland
Query!
State/province [202]
0
0
Lugano
Query!
Country [203]
0
0
Switzerland
Query!
State/province [203]
0
0
Luzern
Query!
Country [204]
0
0
Switzerland
Query!
State/province [204]
0
0
Zürich
Query!
Country [205]
0
0
Taiwan
Query!
State/province [205]
0
0
Kaohsiung
Query!
Country [206]
0
0
Taiwan
Query!
State/province [206]
0
0
Tainan
Query!
Country [207]
0
0
Taiwan
Query!
State/province [207]
0
0
Taipei
Query!
Country [208]
0
0
Taiwan
Query!
State/province [208]
0
0
Taoyuan
Query!
Country [209]
0
0
Thailand
Query!
State/province [209]
0
0
Bangkok
Query!
Country [210]
0
0
Thailand
Query!
State/province [210]
0
0
Pathumwan, Bangkok
Query!
Country [211]
0
0
United Kingdom
Query!
State/province [211]
0
0
Devon
Query!
Country [212]
0
0
United Kingdom
Query!
State/province [212]
0
0
Essex
Query!
Country [213]
0
0
United Kingdom
Query!
State/province [213]
0
0
London
Query!
Country [214]
0
0
United Kingdom
Query!
State/province [214]
0
0
Lothian
Query!
Country [215]
0
0
United Kingdom
Query!
State/province [215]
0
0
Merseyside
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Bayer
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (deep vein thrombosis) or PE (pulmonary embolism) who completed 6 or 12 months of treatment with rivaroxaban or VKA (vitamin K antagonist) are eligible for this trial (Einstein-Extension study).
Query!
Trial website
https://clinicaltrials.gov/study/NCT00439725
Query!
Trial related presentations / publications
Cohen AT, Dobromirski M. The use of rivaroxaban for short- and long-term treatment of venous thromboembolism. Thromb Haemost. 2012 Jun;107(6):1035-43. doi: 10.1160/TH11-12-0859. Epub 2012 Feb 28. EINSTEIN Investigators; Bauersachs R, Berkowitz SD, Brenner B, Buller HR, Decousus H, Gallus AS, Lensing AW, Misselwitz F, Prins MH, Raskob GE, Segers A, Verhamme P, Wells P, Agnelli G, Bounameaux H, Cohen A, Davidson BL, Piovella F, Schellong S. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010 Dec 23;363(26):2499-510. doi: 10.1056/NEJMoa1007903. Epub 2010 Dec 3. Wells PS, Prins MH, Levitan B, Beyer-Westendorf J, Brighton TA, Bounameaux H, Cohen AT, Davidson BL, Prandoni P, Raskob GE, Yuan Z, Katz EG, Gebel M, Lensing AWA. Long-term Anticoagulation With Rivaroxaban for Preventing Recurrent VTE: A Benefit-Risk Analysis of EINSTEIN-Extension. Chest. 2016 Nov;150(5):1059-1068. doi: 10.1016/j.chest.2016.05.023. Epub 2016 Jun 1. Wells PS, Gebel M, Prins MH, Davidson BL, Lensing AW. Influence of statin use on the incidence of recurrent venous thromboembolism and major bleeding in patients receiving rivaroxaban or standard anticoagulant therapy. Thromb J. 2014 Nov 26;12:26. doi: 10.1186/1477-9560-12-26. eCollection 2014.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bayer Study Director
Query!
Address
0
0
Bayer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Cohen AT, Dobromirski M. The use of rivaroxaban fo...
[
More Details
]
Journal
EINSTEIN Investigators; Bauersachs R, Berkowitz SD...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT00439725
Download to PDF