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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
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
Secondary ID [1] 0 0
2006-004494-96
Secondary ID [2] 0 0
11899
Universal Trial Number (UTN)
Trial acronym
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
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Clotting disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
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.

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. For definition of DVT/PE, kindly refer to the link in the Protocol section.
Timepoint [1] 0 0
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), or lung scintigraphy (for PE), and/or case summaries.
Timepoint [1] 0 0
6- or 12-month study treatment period
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 - 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.
Timepoint [2] 0 0
6- or 12-month study treatment period
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 - 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.
Timepoint [3] 0 0
6- or 12-month study treatment period
Secondary outcome [4] 0 0
Percentage of Participants With Recurrent VTE (PE or 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 (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.
Timepoint [4] 0 0
6- or 12-month study treatment period
Secondary outcome [5] 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 [5] 0 0
6- or 12-month study treatment period
Secondary outcome [6] 0 0
Percentage of Participants With Major Bleeding - 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.
Timepoint [6] 0 0
6- or 12-month study treatment period
Secondary outcome [7] 0 0
Percentage of Participants With Clinically Relevant Bleeding - 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
Timepoint [7] 0 0
6- or 12-month study treatment period
Secondary outcome [8] 0 0
Percentage of Participants With All Death - 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)
Timepoint [8] 0 0
6- or 12-month study treatment period
Secondary outcome [9] 0 0
Percentage of Participants With Other Vascular Events - 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)
Timepoint [9] 0 0
6- or 12-month study treatment period

Eligibility
Key inclusion criteria
- Patients with confirmed symptomatic PE or DVT who have been treated for 6 or 12 months
with VKA or rivaroxaban
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)

- 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

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,VIC,WA
Recruitment hospital [1] 0 0
- Garran
Recruitment hospital [2] 0 0
- Gosford
Recruitment hospital [3] 0 0
- Kogarah
Recruitment hospital [4] 0 0
- Lismore
Recruitment hospital [5] 0 0
- St Leonards
Recruitment hospital [6] 0 0
- Sydney
Recruitment hospital [7] 0 0
- Brisbane
Recruitment hospital [8] 0 0
- Redcliffe
Recruitment hospital [9] 0 0
- Southport
Recruitment hospital [10] 0 0
- Woolloongabba
Recruitment hospital [11] 0 0
- Adelaide
Recruitment hospital [12] 0 0
- Box Hill
Recruitment hospital [13] 0 0
- Clayton
Recruitment hospital [14] 0 0
- Geelong
Recruitment hospital [15] 0 0
- Melbourne
Recruitment hospital [16] 0 0
- Prahran
Recruitment hospital [17] 0 0
- Fremantle
Recruitment hospital [18] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2480 - Lismore
Recruitment postcode(s) [5] 0 0
2065 - St Leonards
Recruitment postcode(s) [6] 0 0
2010 - Sydney
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
5011 - Adelaide
Recruitment postcode(s) [15] 0 0
5042 - Adelaide
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
3181 - Prahran
Recruitment postcode(s) [22] 0 0
6160 - Fremantle
Recruitment postcode(s) [23] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
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
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
New Mexico
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Oklahoma
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Utah
Country [15] 0 0
United States of America
State/province [15] 0 0
Vermont
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
Austria
State/province [18] 0 0
Steiermark
Country [19] 0 0
Austria
State/province [19] 0 0
Tirol
Country [20] 0 0
Austria
State/province [20] 0 0
Vorarlberg
Country [21] 0 0
Austria
State/province [21] 0 0
Salzburg
Country [22] 0 0
Austria
State/province [22] 0 0
Wien
Country [23] 0 0
Belgium
State/province [23] 0 0
Bruxelles - Brussel
Country [24] 0 0
Belgium
State/province [24] 0 0
Duffel
Country [25] 0 0
Belgium
State/province [25] 0 0
Genk
Country [26] 0 0
Belgium
State/province [26] 0 0
Gent
Country [27] 0 0
Belgium
State/province [27] 0 0
Hasselt
Country [28] 0 0
Belgium
State/province [28] 0 0
Leuven
Country [29] 0 0
Belgium
State/province [29] 0 0
Liege
Country [30] 0 0
Belgium
State/province [30] 0 0
Lier
Country [31] 0 0
Belgium
State/province [31] 0 0
Namur
Country [32] 0 0
Belgium
State/province [32] 0 0
Sint-Truiden
Country [33] 0 0
Belgium
State/province [33] 0 0
Yvoir
Country [34] 0 0
Belgium
State/province [34] 0 0
Zottegem
Country [35] 0 0
Brazil
State/province [35] 0 0
Minas Gerais
Country [36] 0 0
Brazil
State/province [36] 0 0
Parana
Country [37] 0 0
Brazil
State/province [37] 0 0
Rio Grande do Sul
Country [38] 0 0
Brazil
State/province [38] 0 0
Sao Paulo
Country [39] 0 0
Brazil
State/province [39] 0 0
Rio de Janeiro
Country [40] 0 0
Canada
State/province [40] 0 0
Manitoba
Country [41] 0 0
Canada
State/province [41] 0 0
Ontario
Country [42] 0 0
China
State/province [42] 0 0
Guangdong
Country [43] 0 0
China
State/province [43] 0 0
Heilongjiang
Country [44] 0 0
China
State/province [44] 0 0
Hubei
Country [45] 0 0
China
State/province [45] 0 0
Jiangsu
Country [46] 0 0
China
State/province [46] 0 0
Liaoning
Country [47] 0 0
China
State/province [47] 0 0
Beijing
Country [48] 0 0
China
State/province [48] 0 0
Shanghai
Country [49] 0 0
Czech Republic
State/province [49] 0 0
Brno
Country [50] 0 0
Czech Republic
State/province [50] 0 0
Karlovy Vary
Country [51] 0 0
Czech Republic
State/province [51] 0 0
Kladno
Country [52] 0 0
Czech Republic
State/province [52] 0 0
Ostrava-Poruba
Country [53] 0 0
Czech Republic
State/province [53] 0 0
Ostrava
Country [54] 0 0
Czech Republic
State/province [54] 0 0
Prague 5
Country [55] 0 0
Czech Republic
State/province [55] 0 0
Praha 1
Country [56] 0 0
Czech Republic
State/province [56] 0 0
Praha 2
Country [57] 0 0
Czech Republic
State/province [57] 0 0
Praha 4
Country [58] 0 0
Czech Republic
State/province [58] 0 0
Usti nad Lebem
Country [59] 0 0
Denmark
State/province [59] 0 0
Aarhus C
Country [60] 0 0
Denmark
State/province [60] 0 0
Braedstrup
Country [61] 0 0
Denmark
State/province [61] 0 0
Frederiksberg
Country [62] 0 0
Denmark
State/province [62] 0 0
Hellerup
Country [63] 0 0
Finland
State/province [63] 0 0
Seinäjoki
Country [64] 0 0
France
State/province [64] 0 0
Agen Cedex 9
Country [65] 0 0
France
State/province [65] 0 0
Amiens
Country [66] 0 0
France
State/province [66] 0 0
Angers Cedex 01
Country [67] 0 0
France
State/province [67] 0 0
Arras
Country [68] 0 0
France
State/province [68] 0 0
Bordeaux
Country [69] 0 0
France
State/province [69] 0 0
Brest Cedex
Country [70] 0 0
France
State/province [70] 0 0
Castelnau Le Lez
Country [71] 0 0
France
State/province [71] 0 0
Clamart
Country [72] 0 0
France
State/province [72] 0 0
Clermont Ferrand
Country [73] 0 0
France
State/province [73] 0 0
Colombes
Country [74] 0 0
France
State/province [74] 0 0
Creteil
Country [75] 0 0
France
State/province [75] 0 0
Dijon
Country [76] 0 0
France
State/province [76] 0 0
Grenoble
Country [77] 0 0
France
State/province [77] 0 0
Lille Cedex
Country [78] 0 0
France
State/province [78] 0 0
Limoges
Country [79] 0 0
France
State/province [79] 0 0
Montpellier Cedex
Country [80] 0 0
France
State/province [80] 0 0
Nantes
Country [81] 0 0
France
State/province [81] 0 0
Nimes Cedex 9
Country [82] 0 0
France
State/province [82] 0 0
Orthez
Country [83] 0 0
France
State/province [83] 0 0
Paris Cedex 15
Country [84] 0 0
France
State/province [84] 0 0
Paris
Country [85] 0 0
France
State/province [85] 0 0
Pierre Benite
Country [86] 0 0
France
State/province [86] 0 0
Roanne
Country [87] 0 0
France
State/province [87] 0 0
Rouen Cedex
Country [88] 0 0
France
State/province [88] 0 0
Saint Etienne
Country [89] 0 0
France
State/province [89] 0 0
Strasbourg Cedex
Country [90] 0 0
France
State/province [90] 0 0
Toulon
Country [91] 0 0
France
State/province [91] 0 0
Toulouse
Country [92] 0 0
France
State/province [92] 0 0
Tours
Country [93] 0 0
France
State/province [93] 0 0
Valenciennes Cedex
Country [94] 0 0
France
State/province [94] 0 0
Vandoeuvre Les Nancy
Country [95] 0 0
France
State/province [95] 0 0
Vernon
Country [96] 0 0
Germany
State/province [96] 0 0
Baden-Württemberg
Country [97] 0 0
Germany
State/province [97] 0 0
Bayern
Country [98] 0 0
Germany
State/province [98] 0 0
Hessen
Country [99] 0 0
Germany
State/province [99] 0 0
Mecklenburg-Vorpommern
Country [100] 0 0
Germany
State/province [100] 0 0
Niedersachsen
Country [101] 0 0
Germany
State/province [101] 0 0
Nordrhein-Westfalen
Country [102] 0 0
Germany
State/province [102] 0 0
Rheinland-Pfalz
Country [103] 0 0
Germany
State/province [103] 0 0
Saarland
Country [104] 0 0
Germany
State/province [104] 0 0
Sachsen-Anhalt
Country [105] 0 0
Germany
State/province [105] 0 0
Sachsen
Country [106] 0 0
Germany
State/province [106] 0 0
Berlin
Country [107] 0 0
Germany
State/province [107] 0 0
Hamburg
Country [108] 0 0
Hong Kong
State/province [108] 0 0
Hong Kong
Country [109] 0 0
Hungary
State/province [109] 0 0
Budapest
Country [110] 0 0
Hungary
State/province [110] 0 0
Debrecen
Country [111] 0 0
Hungary
State/province [111] 0 0
Kecskemet
Country [112] 0 0
Hungary
State/province [112] 0 0
Kistarcsa
Country [113] 0 0
Hungary
State/province [113] 0 0
Miskolc
Country [114] 0 0
Hungary
State/province [114] 0 0
Nyiregyhaza
Country [115] 0 0
Hungary
State/province [115] 0 0
Szentes
Country [116] 0 0
Hungary
State/province [116] 0 0
Szombathely
Country [117] 0 0
India
State/province [117] 0 0
Kerala
Country [118] 0 0
India
State/province [118] 0 0
Maharashtra
Country [119] 0 0
India
State/province [119] 0 0
Hyderabad
Country [120] 0 0
India
State/province [120] 0 0
Kolkata
Country [121] 0 0
India
State/province [121] 0 0
New Delhi
Country [122] 0 0
India
State/province [122] 0 0
Pune
Country [123] 0 0
Indonesia
State/province [123] 0 0
Bandung
Country [124] 0 0
Indonesia
State/province [124] 0 0
Jakarta
Country [125] 0 0
Indonesia
State/province [125] 0 0
Medan
Country [126] 0 0
Indonesia
State/province [126] 0 0
Semarang
Country [127] 0 0
Israel
State/province [127] 0 0
Afula
Country [128] 0 0
Israel
State/province [128] 0 0
Ashkelon
Country [129] 0 0
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
Country [132] 0 0
Israel
State/province [132] 0 0
Jerusalem
Country [133] 0 0
Israel
State/province [133] 0 0
Kfar Saba
Country [134] 0 0
Israel
State/province [134] 0 0
Petach Tikva
Country [135] 0 0
Israel
State/province [135] 0 0
Rehovot
Country [136] 0 0
Israel
State/province [136] 0 0
Safed
Country [137] 0 0
Israel
State/province [137] 0 0
Tel Aviv
Country [138] 0 0
Italy
State/province [138] 0 0
Bologna
Country [139] 0 0
Italy
State/province [139] 0 0
Chieti
Country [140] 0 0
Italy
State/province [140] 0 0
Milano
Country [141] 0 0
Italy
State/province [141] 0 0
Napoli
Country [142] 0 0
Italy
State/province [142] 0 0
Padova
Country [143] 0 0
Italy
State/province [143] 0 0
Palermo
Country [144] 0 0
Italy
State/province [144] 0 0
Parma
Country [145] 0 0
Italy
State/province [145] 0 0
Pavia
Country [146] 0 0
Italy
State/province [146] 0 0
Piacenza
Country [147] 0 0
Italy
State/province [147] 0 0
Venezia
Country [148] 0 0
Korea, Republic of
State/province [148] 0 0
Daegu Gwang'yeogsi
Country [149] 0 0
Korea, Republic of
State/province [149] 0 0
Seoul Teugbyeolsi
Country [150] 0 0
Korea, Republic of
State/province [150] 0 0
Daegu
Country [151] 0 0
Korea, Republic of
State/province [151] 0 0
Seoul
Country [152] 0 0
Korea, Republic of
State/province [152] 0 0
Taegu
Country [153] 0 0
Malaysia
State/province [153] 0 0
Selangor
Country [154] 0 0
Netherlands
State/province [154] 0 0
Amsterdam
Country [155] 0 0
Netherlands
State/province [155] 0 0
Arnhem
Country [156] 0 0
Netherlands
State/province [156] 0 0
Den Bosch
Country [157] 0 0
Netherlands
State/province [157] 0 0
Dordrecht
Country [158] 0 0
Netherlands
State/province [158] 0 0
Enschede
Country [159] 0 0
Netherlands
State/province [159] 0 0
Groningen
Country [160] 0 0
Netherlands
State/province [160] 0 0
Hoofddorp
Country [161] 0 0
Netherlands
State/province [161] 0 0
Maastricht
Country [162] 0 0
Netherlands
State/province [162] 0 0
Rotterdam
Country [163] 0 0
Netherlands
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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, 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).
Trial website
https://clinicaltrials.gov/show/NCT00439725
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