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
NCT ID: NCT00439725
Last Updated: 2014-11-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1197 participants
INTERVENTIONAL
2007-02-28
2009-09-30
Brief Summary
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Detailed Description
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The treatment period was followed by an observational period of 30 days starting the day after the last intake of study medication, regardless of the actual duration of study drug administration. Participants who did not complete the treatment period also entered the observational period. It was also possible that participants did not enter the observational period, e.g. due to withdrawal of consent or termination of study participation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Rivaroxaban (Xarelto, BAY59-7939)
Participants were to receive rivaroxaban 20 mg oral tablet once daily
Rivaroxaban (Xarelto, BAY59-7939)
Patients randomized to rivaroxaban will receive rivaroxaban 20 mg once-daily.
Placebo
Participants were to receive matching placebo oral tablet once daily
Placebo
Patients allocated to placebo will receive a matching placebo tablet once daily.
Interventions
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Rivaroxaban (Xarelto, BAY59-7939)
Patients randomized to rivaroxaban will receive rivaroxaban 20 mg once-daily.
Placebo
Patients allocated to placebo will receive a matching placebo tablet once daily.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Vandœuvre-lès-Nancy, , France
Vernon, , France
Bruchsal, Baden-Wurttemberg, Germany
Heidelberg, Baden-Wurttemberg, Germany
Karlsbad, Baden-Wurttemberg, Germany
Mannheim, Baden-Wurttemberg, Germany
Neckargemünd, Baden-Wurttemberg, Germany
Tübingen, Baden-Wurttemberg, Germany
Augsburg, Bavaria, Germany
München, Bavaria, Germany
München, Bavaria, Germany
Würzburg, Bavaria, Germany
Hamburg, City state of Hamburg, Germany
Darmstadt, Hesse, Germany
Frankfurt am Main, Hesse, Germany
Giessen, Hesse, Germany
Wiesbaden, Hesse, Germany
Hanover, Lower Saxony, Germany
Rotenburg (Wümme), Lower Saxony, Germany
Greifswald, Mecklenburg-Vorpommern, Germany
Düsseldorf, North Rhine-Westphalia, Germany
Essen, North Rhine-Westphalia, Germany
Paderborn, North Rhine-Westphalia, Germany
Soest, North Rhine-Westphalia, Germany
Witten, North Rhine-Westphalia, Germany
Mainz, Rhineland-Palatinate, Germany
Homburg, Saarland, Germany
Homburg, Saarland, Germany
Dresden, Saxony, Germany
Leipzig, Saxony, Germany
Halle, Saxony-Anhalt, Germany
Magdeburg, Saxony-Anhalt, Germany
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Hong Kong, , Hong Kong
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Kecskemét, , Hungary
Kistarcsa, , Hungary
Miskolc, , Hungary
Nyíregyháza, , Hungary
Szentes, , Hungary
Szombathely, , Hungary
Kochi, Kerala, India
Vellore, Kerala, India
Mumbai, Maharashtra, India
Mumbai, Maharashtra, India
Mumbai, Maharashtra, India
Hyderabad, , India
Kolkata, , India
New Delhi, , India
Pune, , India
Bandung, , Indonesia
Jakarta, , Indonesia
Medan, , Indonesia
Semarang, , Indonesia
Haifa, Israel, Israel
Petah Tikva, Israel, Israel
Afula, , Israel
Ostrava, , Czechia
Ostrava-Poruba, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Usti Nad Lebem, , Czechia
Aarhus C, , Denmark
Brædstrup, , Denmark
Frederiksberg, , Denmark
Hellerup, , Denmark
Seinäjoki, , Finland
Agen, , France
Amiens, , France
Angers, , France
Arras, , France
Bordeaux, , France
Brest, , France
Castelnau-le-Lez, , France
Clamart, , France
Clermont-Ferrand, , France
Colombes, , France
Créteil, , France
Dijon, , France
Grenoble, , France
Grenoble, , France
Lille, , France
Limoges, , France
Montpellier, , France
Nantes, , France
Nîmes, , France
Orthez, , France
Paris, , France
Paris, , France
Paris, , France
Paris, , France
Pierre-Bénite, , France
Roanne, , France
Rouen, , France
Saint-Etienne, , France
Strasbourg, , France
Toulon, , France
Toulouse, , France
Tours, , France
Valenciennes, , France
Little Rock, Arkansas, United States
Los Angeles, California, United States
Redlands, California, United States
Bay Pines, Florida, United States
Melbourne, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Decatur, Georgia, United States
Idaho Falls, Idaho, United States
Covington, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Albuquerque, New Mexico, United States
Chapel Hill, North Carolina, United States
Greensboro, North Carolina, United States
Greensboro, North Carolina, United States
Oklahoma City, Oklahoma, United States
Pittsburgh, Pennsylvania, United States
Corsicana, Texas, United States
San Antonio, Texas, United States
Murray, Utah, United States
Salt Lake City, Utah, United States
Burlington, Vermont, United States
Fredericksburg, Virginia, United States
Spokane, Washington, United States
Garran, Australian Capital Territory, Australia
Gosford, New South Wales, Australia
Kogarah, New South Wales, Australia
Lismore, New South Wales, Australia
St Leonards, New South Wales, Australia
Sydney, New South Wales, Australia
Sydney, New South Wales, Australia
Sydney, New South Wales, Australia
Sydney, New South Wales, Australia
Brisbane, Queensland, Australia
Redcliffe, Queensland, Australia
Southport, Queensland, Australia
Woolloongabba, Queensland, Australia
Adelaide, South Australia, Australia
Adelaide, South Australia, Australia
Box Hill, Victoria, Australia
Clayton, Victoria, Australia
Geelong, Victoria, Australia
Melbourne, Victoria, Australia
Melbourne, Victoria, Australia
Prahran, Victoria, Australia
Fremantle, Western Australia, Australia
Perth, Western Australia, Australia
Salzburg, Salzburg, Austria
Graz, Styria, Austria
Innsbruck, Tyrol, Austria
Vienna, Vienna, Austria
Vienna, Vienna, Austria
Feldkirch, Vorarlberg, Austria
Bruxelles - Brussel, , Belgium
Bruxelles - Brussel, , Belgium
Duffel, , Belgium
Genk, , Belgium
Ghent, , Belgium
Hasselt, , Belgium
Leuven, , Belgium
Lier, , Belgium
Liège, , Belgium
Namur, , Belgium
Sint-Truiden, , Belgium
Yvoir, , Belgium
Zottegem, , Belgium
Uberaba, Minas Gerais, Brazil
Curitiba, Paraná, Brazil
Londrina, Paraná, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Botucatu, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Sorocaba, São Paulo, Brazil
Rio de Janeiro, , Brazil
Winnipeg, Manitoba, Canada
Toronto, Ontario, Canada
Guangzhou, Guangdong, China
Harbin, Heilongjiang, China
Wuhan, Hubei, China
Suzhou, Jiangsu, China
Shenyang, Liaoning, China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Brno, , Czechia
Karlovy Vary, , Czechia
Kladno, , Czechia
Ashkelon, , Israel
Beersheba, , Israel
Haifa, , Israel
Haifa, , Israel
Holon, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Rehovot, , Israel
Safed, , Israel
Tel Aviv, , Israel
Bologna, , Italy
Chieti, , Italy
Milan, , Italy
Milan, , Italy
Napoli, , Italy
Padua, , Italy
Palermo, , Italy
Parma, , Italy
Pavia, , Italy
Piacenza, , Italy
Venezia, , Italy
Kuala Selangor, , Malaysia
's-Hertogenbosch, , Netherlands
Amsterdam, , Netherlands
Arnhem, , Netherlands
Dordrecht, , Netherlands
Enschede, , Netherlands
Groningen, , Netherlands
Hoofddorp, , Netherlands
Maastricht, , Netherlands
Rotterdam, , Netherlands
Zwijndrecht, , Netherlands
Zwolle, , Netherlands
Auckland, , New Zealand
Auckland, , New Zealand
Christchurch, , New Zealand
Palmerston North, , New Zealand
Wellington South, , New Zealand
Fredrikstad, , Norway
Oslo, , Norway
Oslo, , Norway
Rud, , Norway
Quezon City, , Philippines
Quezon City, , Philippines
Bialystok, , Poland
Bydgoszcz, , Poland
Gdansk, , Poland
Katowice, , Poland
Krakow, , Poland
Lodz, , Poland
Lublin, , Poland
Poznan, , Poland
Poznan, , Poland
Torun, , Poland
Warsaw, , Poland
Warsaw, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Wroclaw, , Poland
Singapore, , Singapore
Singapore, , Singapore
Cape Town, Cape, South Africa
Johannesburg, Gauteng, South Africa
Johannesburg, Gauteng, South Africa
Johannesburg, Gauteng, South Africa
Johannesburg, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Roodepoort, Gauteng, South Africa
Cape Town, Western Cape, South Africa
Somerset West, Western Cape, South Africa
Worcester, Western Cape, South Africa
Daegu, Daegu Gwang'yeogsi, South Korea
Seoul, Seoul Teugbyeolsi, South Korea
Daegu, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Taegu, , South Korea
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Terrassa, Barcelona, Spain
Girona, Girona, Spain
Alcorcón, Madrid, Spain
Fuenlabrada, Madrid, Spain
Madrid, Madrid, Spain
Pamplona, Pamplona, Spain
Xàtiva, Valencia, Spain
Borås, , Sweden
Gothenburg, , Sweden
Gothenburg, , Sweden
Jönköping, , Sweden
Sundsvall, , Sweden
Västervik, , Sweden
Bruderholz, Basel-Landschaft, Switzerland
Zurich, Canton of Zurich, Switzerland
Genéve 14, Genève 14, Switzerland
Chur, Kanton Graubünden, Switzerland
Brig, Valais, Switzerland
Lucerne, , Switzerland
Lugano, , Switzerland
Kaohsiung City, , Taiwan
Tainan City, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taoyuan District, , Taiwan
Bangkok, Bangkok, Thailand
Pathumwan, Bangkok, Thailand, Thailand
Bangkok, , Thailand
Plymouth, Devon, United Kingdom
Chelmsford, Essex, United Kingdom
Romford, Essex, United Kingdom
Isleworth, London, United Kingdom
London, London, United Kingdom
London, London, United Kingdom
Edinburgh, Lothian, United Kingdom
Liverpool, Merseyside, United Kingdom
London, , United Kingdom
London, , United Kingdom
Countries
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References
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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.
Dobesh 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.
Yamada 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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Click here to find the definition for Deep Vein Thrombosis \[DVT\].
Click here to find the definition for Pulmonary Embolism \[PE\].
Click here and search for information of Bayer products for Europe
Other Identifiers
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2006-004494-96
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
11899
Identifier Type: -
Identifier Source: org_study_id
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