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
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
2 other identifiers
interventional
1,197
32 countries
316
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2007
Typical duration for phase_3
316 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 23, 2007
CompletedFirst Posted
Study publicly available on registry
February 26, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedResults Posted
Study results publicly available
April 12, 2012
CompletedNovember 4, 2014
October 1, 2014
2.5 years
February 23, 2007
January 31, 2012
October 28, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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.
6- or 12-month study treatment period
Secondary Outcomes (9)
Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment
6- or 12-month study treatment period
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
6- or 12-month study treatment period
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
6- or 12-month study treatment period
Percentage of Participants With Recurrent VTE (PE or DVT) Until the Intended End of Study Treatment
6- or 12-month study treatment period
Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment
6- or 12-month study treatment period
- +4 more secondary outcomes
Other Outcomes (10)
Percentage of Participants With Death (PE) Until the Intended End of Study Treatment
6- or 12-month study treatment period
Percentage of Participants With Death (PE Cannot be Excluded) Until the Intended End of Study Treatment
6- or 12-month study treatment period
Percentage of Participants With Symptomatic Recurrent PE Until the Intended End of Study Treatment
6- or 12-month study treatment period
- +7 more other outcomes
Study Arms (2)
Rivaroxaban (Xarelto, BAY59-7939)
EXPERIMENTALParticipants were to receive rivaroxaban 20 mg oral tablet once daily
Placebo
PLACEBO COMPARATORParticipants were to receive matching placebo oral tablet once daily
Interventions
Patients randomized to rivaroxaban will receive rivaroxaban 20 mg once-daily.
Eligibility Criteria
You may qualify if:
- Patients with confirmed symptomatic PE or DVT who have been treated for 6 or 12 months with VKA or rivaroxaban
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (322)
Unknown Facility
Little Rock, Arkansas, 72205, United States
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Los Angeles, California, 90095, United States
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Redlands, California, 92373, United States
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Bay Pines, Florida, 33744, United States
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Melbourne, Florida, 32901, United States
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Miami, Florida, 33136-1096, United States
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Miami, Florida, 33136, United States
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Decatur, Georgia, 30033, United States
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Idaho Falls, Idaho, 83404, United States
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Covington, Louisiana, 70433, United States
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Baltimore, Maryland, 21215-5271, United States
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Boston, Massachusetts, 02215, United States
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Albuquerque, New Mexico, 87108, United States
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Chapel Hill, North Carolina, 27599-7035, United States
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Greensboro, North Carolina, 27401, United States
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Greensboro, North Carolina, 27403, United States
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Oklahoma City, Oklahoma, 73104, United States
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Pittsburgh, Pennsylvania, 15224, United States
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Corsicana, Texas, 75110, United States
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San Antonio, Texas, 78229, United States
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Murray, Utah, 84107, United States
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Salt Lake City, Utah, 84132, United States
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Burlington, Vermont, 05401, United States
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Fredericksburg, Virginia, 22401, United States
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Spokane, Washington, 99204, United States
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Garran, Australian Capital Territory, 2605, Australia
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Gosford, New South Wales, 2250, Australia
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Kogarah, New South Wales, 2217, Australia
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Lismore, New South Wales, 2480, Australia
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St Leonards, New South Wales, 2065, Australia
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Sydney, New South Wales, 2010, Australia
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Sydney, New South Wales, 2031, Australia
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Sydney, New South Wales, 2139, Australia
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Sydney, New South Wales, 2229, Australia
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Brisbane, Queensland, 4029, Australia
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Redcliffe, Queensland, 4020, Australia
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Southport, Queensland, 4215, Australia
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Woolloongabba, Queensland, 4102, Australia
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Adelaide, South Australia, 5011, Australia
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Adelaide, South Australia, 5042, Australia
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Box Hill, Victoria, 3128, Australia
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Clayton, Victoria, 3168, Australia
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Geelong, Victoria, 3220, Australia
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Melbourne, Victoria, 3135, Australia
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Melbourne, Victoria, 3181, Australia
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Prahran, Victoria, 3181, Australia
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Fremantle, Western Australia, 6160, Australia
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Perth, Western Australia, 6000, Australia
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Salzburg, Salzburg, 5020, Austria
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Graz, Styria, 8036, Austria
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Innsbruck, Tyrol, 6020, Austria
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Vienna, Vienna, 1090, Austria
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Vienna, Vienna, 1140, Austria
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Feldkirch, Vorarlberg, 6807, Austria
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Bruxelles - Brussel, 1070, Belgium
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Bruxelles - Brussel, 1200, Belgium
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Duffel, 2570, Belgium
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Genk, 3600, Belgium
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Ghent, 9000, Belgium
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Hasselt, 3500, Belgium
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Leuven, 3000, Belgium
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Lier, 2500, Belgium
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Liège, 4000, Belgium
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Namur, 5000, Belgium
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Sint-Truiden, 3800, Belgium
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Yvoir, 5530, Belgium
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Zottegem, 9620, Belgium
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Uberaba, Minas Gerais, 38010 380, Brazil
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Curitiba, Paraná, 80050-350, Brazil
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Londrina, Paraná, 86038440, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Botucatu, São Paulo, 18618 000, Brazil
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São Paulo, São Paulo, 01323-001, Brazil
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São Paulo, São Paulo, 01509-900, Brazil
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São Paulo, São Paulo, 04023-061, Brazil
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São Paulo, São Paulo, 04039-004, Brazil
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Sorocaba, São Paulo, 18031-000, Brazil
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Rio de Janeiro, Brazil
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Winnipeg, Manitoba, R2H 2A6, Canada
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Toronto, Ontario, M6R 1B5, Canada
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Guangzhou, Guangdong, 510080, China
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Harbin, Heilongjiang, 150086, China
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Wuhan, Hubei, 430022, China
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Suzhou, Jiangsu, 215004, China
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Shenyang, Liaoning, 110016, China
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Beijing, 100020, China
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Beijing, 100029, China
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Beijing, 100037, China
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Beijing, 100038, China
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Beijing, 100044, China
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Beijing, 100730, China
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Beijing, 100853, China
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Shanghai, 200001, China
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Shanghai, 200032, China
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Shanghai, 200433, China
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Brno, 65691, Czechia
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Karlovy Vary, 360 00, Czechia
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Kladno, 27259, Czechia
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Ostrava, 728 80, Czechia
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Ostrava-Poruba, 708 52, Czechia
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Prague, 110 00, Czechia
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Prague, 12800, Czechia
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Prague, 140 21, Czechia
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Prague, 150 00, Czechia
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Usti Nad Lebem, 401 13, Czechia
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Aarhus C, 8000, Denmark
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Brædstrup, 8740, Denmark
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Frederiksberg, 2000F, Denmark
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Hellerup, 2900, Denmark
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Seinäjoki, 60220, Finland
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Agen, 47923, France
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Amiens, 80000, France
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Angers, 49033, France
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Arras, 62000, France
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Bordeaux, 33075, France
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Brest, 29609, France
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Castelnau-le-Lez, 34170, France
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Clamart, 92141, France
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Clermont-Ferrand, 63000, France
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Colombes, 92700, France
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Créteil, 94000, France
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Dijon, 21000, France
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Grenoble, 38028, France
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Grenoble, 38043, France
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Lille, 59037, France
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Limoges, 87042, France
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Montpellier, 34295, France
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Nantes, 44000, France
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Nîmes, 30029, France
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Orthez, 64300, France
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Paris, 75004, France
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Paris, 75475, France
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Paris, 75877, France
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Paris, 75908, France
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Pierre-Bénite, 69495, France
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Roanne, 42328, France
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Rouen, 76031, France
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Saint-Etienne, 42055, France
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Strasbourg, 67091, France
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Toulon, 83000, France
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Toulouse, 31403, France
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Tours, 37044, France
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Valenciennes, 59322, France
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Vandœuvre-lès-Nancy, 54511, France
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Vernon, 27200, France
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Bruchsal, Baden-Wurttemberg, 76646, Germany
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Heidelberg, Baden-Wurttemberg, 69115, Germany
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Karlsbad, Baden-Wurttemberg, 76307, Germany
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Mannheim, Baden-Wurttemberg, 68167, Germany
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Neckargemünd, Baden-Wurttemberg, 69151, Germany
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Tübingen, Baden-Wurttemberg, 72076, Germany
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Augsburg, Bavaria, 86156, Germany
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München, Bavaria, 80331, Germany
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München, Bavaria, 81377, Germany
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Würzburg, Bavaria, 97080, Germany
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Hamburg, Hamburg, 20251, Germany
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Darmstadt, Hesse, 64297, Germany
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Frankfurt am Main, Hesse, 60596, Germany
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Giessen, Hesse, 35392, Germany
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Wiesbaden, Hesse, 65183, Germany
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Hanover, Lower Saxony, 30625, Germany
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Rotenburg (Wümme), Lower Saxony, 27342, Germany
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Greifswald, Mecklenburg-Vorpommern, 17475, Germany
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Düsseldorf, North Rhine-Westphalia, 40225, Germany
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Essen, North Rhine-Westphalia, 45122, Germany
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Paderborn, North Rhine-Westphalia, 33098, Germany
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Soest, North Rhine-Westphalia, 59494, Germany
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Witten, North Rhine-Westphalia, 58455, Germany
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Mainz, Rhineland-Palatinate, 55131, Germany
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Homburg, Saarland, 66421, Germany
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Homburg, Saarland, 66424, Germany
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Dresden, Saxony, 01307, Germany
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Leipzig, Saxony, 04289, Germany
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Halle, Saxony-Anhalt, 06120, Germany
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Magdeburg, Saxony-Anhalt, 39112, Germany
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Berlin, State of Berlin, 10713, Germany
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Berlin, State of Berlin, 12099, Germany
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Hong Kong, Hong Kong
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Budapest, 1096, Hungary
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Budapest, 1115, Hungary
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Debrecen, 4032, Hungary
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Kecskemét, 6000, Hungary
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Kistarcsa, 2143, Hungary
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Miskolc, 3526, Hungary
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Nyíregyháza, 4400, Hungary
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Szentes, 6600, Hungary
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Szombathely, 9700, Hungary
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Kochi, Kerala, 682026, India
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Vellore, Kerala, 632004, India
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Mumbai, Maharashtra, 400008, India
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Mumbai, Maharashtra, 400016, India
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Mumbai, Maharashtra, 400022, India
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Hyderabad, 500082, India
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Kolkata, 700029, India
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New Delhi, 110060, India
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Pune, 411001, India
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Bandung, 40161, Indonesia
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Jakarta, 10430, Indonesia
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Medan, 20152, Indonesia
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Semarang, 50241, Indonesia
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Haifa, Israel, 34362, Israel
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Petah Tikva, Israel, 49100, Israel
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Afula, 18101, Israel
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Ashkelon, 78278, Israel
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Beersheba, 84101, Israel
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Haifa, 31048, Israel
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Haifa, 31096, Israel
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Holon, 58100, Israel
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Jerusalem, 91120, Israel
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Kfar Saba, 44281, Israel
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Rehovot, 76100, Israel
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Safed, 13100, Israel
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Tel Aviv, 64239, Israel
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Bologna, 40138, Italy
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Chieti, 66013, Italy
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Milan, 20132, Italy
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Milan, 20142, Italy
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Napoli, 80131, Italy
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Padua, 35128, Italy
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Palermo, 90127, Italy
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Parma, 43100, Italy
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Pavia, 27100, Italy
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Piacenza, 29100, Italy
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Venezia, 30122, Italy
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Kuala Selangor, 68000, Malaysia
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's-Hertogenbosch, 5223 GZ, Netherlands
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Amsterdam, 1105 AZ, Netherlands
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Arnhem, 6815 AD, Netherlands
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Dordrecht, 3318 AT, Netherlands
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Enschede, 7511 JX, Netherlands
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Groningen, 9713 GZ, Netherlands
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Hoofddorp, 2134 TM, Netherlands
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Maastricht, 6229 HX, Netherlands
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Rotterdam, 3083 AN, Netherlands
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Zwijndrecht, 3331 LZ, Netherlands
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Zwolle, 8025 AB, Netherlands
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Auckland, 0622, New Zealand
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Auckland, 1023, New Zealand
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Christchurch, 8011, New Zealand
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Palmerston North, 4414, New Zealand
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Wellington South, 6021, New Zealand
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Fredrikstad, 1603, Norway
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Oslo, 0407, Norway
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Oslo, 0514, Norway
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Rud, 1309, Norway
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Quezon City, 0850, Philippines
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Quezon City, 1102, Philippines
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Bialystok, 15-276, Poland
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Bydgoszcz, 85-168, Poland
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Gdansk, 80-952, Poland
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Katowice, 40-365, Poland
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Krakow, 31-066, Poland
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Lodz, 90-153, Poland
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Lublin, 20-081, Poland
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Poznan, 60-631, Poland
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Poznan, 61-848, Poland
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Torun, 87-100, Poland
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Warsaw, 01-138, Poland
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Warsaw, 02-097, Poland
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Warsaw, 04-479, Poland
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Wroclaw, 50-326, Poland
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Wroclaw, 51-124, Poland
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Singapore, 169608, Singapore
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Singapore, 308433, Singapore
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Cape Town, Cape, 7500, South Africa
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Johannesburg, Gauteng, 2132, South Africa
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Johannesburg, Gauteng, 2157, South Africa
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Johannesburg, Gauteng, 2191, South Africa
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Johannesburg, Gauteng, 2193, South Africa
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Pretoria, Gauteng, 0084, South Africa
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Pretoria, Gauteng, 0157, South Africa
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Pretoria, Gauteng, 0181, South Africa
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Roodepoort, Gauteng, 1724, South Africa
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Cape Town, Western Cape, 7460, South Africa
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Somerset West, Western Cape, 7130, South Africa
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Worcester, Western Cape, 6850, South Africa
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Daegu, Daegu Gwang'yeogsi, 700721, South Korea
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Seoul, Seoul Teugbyeolsi, 110-744, South Korea
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Daegu, 705-718, South Korea
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Seoul, 120-752, South Korea
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Seoul, 137-701, South Korea
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Taegu, 700-712, South Korea
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Barcelona, Barcelona, 08025, Spain
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Barcelona, Barcelona, 08036, Spain
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Terrassa, Barcelona, 08221, Spain
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Girona, Girona, 17007, Spain
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Alcorcón, Madrid, 28922, Spain
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Fuenlabrada, Madrid, 28942, Spain
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Madrid, Madrid, 28034, Spain
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Pamplona, Pamplona, 31008, Spain
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Xàtiva, Valencia, 46800, Spain
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Borås, 501 82, Sweden
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Gothenburg, 413 45, Sweden
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Gothenburg, 416 85, Sweden
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Jönköping, 551 85, Sweden
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Sundsvall, 851 86, Sweden
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Västervik, 593 81, Sweden
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Bruderholz, Basel-Landschaft, 4101, Switzerland
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Zurich, Canton of Zurich, 8091, Switzerland
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Genéve 14, Genève 14, 1211, Switzerland
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Chur, Kanton Graubünden, 7000, Switzerland
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Brig, Valais, 3900, Switzerland
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Lucerne, 6000, Switzerland
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Lugano, 6903, Switzerland
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Kaohsiung City, 80756, Taiwan
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Tainan, 704, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 11217, Taiwan
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Taoyuan District, 333, Taiwan
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Bangkok, Bangkok, 10700, Thailand
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Pathumwan, Bangkok, Thailand, 10330, Thailand
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Bangkok, 10400, Thailand
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Plymouth, Devon, PL6 8DH, United Kingdom
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Chelmsford, Essex, CM1 5ET, United Kingdom
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Romford, Essex, RM7 0AG, United Kingdom
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Isleworth, London, TW7 6AF, United Kingdom
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London, London, SE1 7EH, United Kingdom
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London, London, SE5 9RS, United Kingdom
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Edinburgh, Lothian, EH16 4SA, United Kingdom
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Liverpool, Merseyside, L7 8XP, United Kingdom
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London, W1T 4EU, United Kingdom
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London, United Kingdom
Related Publications (6)
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.
PMID: 22371186RESULTEINSTEIN 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.
PMID: 21128814RESULTDobesh PP, Volkl AA, Pap AF, Damaraju CV, Levitan B, Yuan Z, Amin AN. Benefit-Risk Assessment of Rivaroxaban in Older Patients With Nonvalvular Atrial Fibrillation or Venous Thromboembolism. Drugs Aging. 2025 May;42(5):469-484. doi: 10.1007/s40266-025-01192-7. Epub 2025 Mar 31.
PMID: 40163217DERIVEDYamada N, Fu W, Shi Z, Park KH, Kim HS, Dai X, Lensing AW, Pap AF, Kohno T, Tajima T, Watakabe T, Mitsumori T. Risk of recurrent venous thromboembolism and major bleeding according to risk factor profiles in Asian patients: a subgroup analysis EINSTEIN-Extension and EINSTEIN-CHOICE. Thromb J. 2024 Jun 6;22(1):48. doi: 10.1186/s12959-024-00609-4.
PMID: 38844941DERIVEDWells 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.
PMID: 27262225DERIVEDWells 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.
PMID: 25698905DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2007
First Posted
February 26, 2007
Study Start
February 1, 2007
Primary Completion
August 1, 2009
Study Completion
September 1, 2009
Last Updated
November 4, 2014
Results First Posted
April 12, 2012
Record last verified: 2014-10