Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis - The EINSTEIN DVT Study
NCT ID: NCT00440193
Last Updated: 2014-02-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
3449 participants
INTERVENTIONAL
2007-03-31
2010-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
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
NCT00439725
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism - The EINSTEIN PE Study
NCT00439777
Once-daily Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Deep-vein Thrombosis
NCT00395772
Deep Vein Thrombosis Treatment With the Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients Using a Strong CYP 3A4 Inducer
NCT00786422
Treatment of an Acute Deep Vein Thrombosis (DVT) With Either Rivaroxaban or Current Standard of Care Therapy
NCT01619007
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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. Participants who were transferring from study 11702 DVT (NCT00440193) to the extension study 11899 (NCT00439725) did not enter the observational period.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Rivaroxaban (Xarelto, BAY59-7939)
Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
Rivaroxaban (Xarelto, BAY59-7939)
During the first 3 weeks patients will receive 15 mg rivaroxaban twice-daily. Thereafter, patients will receive rivaroxaban 20 mg once-daily. Rivaroxaban will be administered orally and should be taken with food.
Enoxaparin/VKA
Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
Enoxaparin followed by VKA
Enoxaparin 1.0 mg/kg twice daily with a minimal duration of 5 days. This 5 days treatment could include the period up to 36 h before randomization if enoxaparin twice-daily was used. VKA should be started as soon as possible but not later than 48 hours after randomization.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rivaroxaban (Xarelto, BAY59-7939)
During the first 3 weeks patients will receive 15 mg rivaroxaban twice-daily. Thereafter, patients will receive rivaroxaban 20 mg once-daily. Rivaroxaban will be administered orally and should be taken with food.
Enoxaparin followed by VKA
Enoxaparin 1.0 mg/kg twice daily with a minimal duration of 5 days. This 5 days treatment could include the period up to 36 h before randomization if enoxaparin twice-daily was used. VKA should be started as soon as possible but not later than 48 hours after randomization.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE
* Other indication for VKA than DVT and/or PE
* The pre-randomization anti-coagulant treatment (Criteria # 4) has been prolonged from 36 hours to a maximum of 48 hours.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
Bayer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Little Rock, Arkansas, United States
Redlands, California, United States
Bay Pines, Florida, United States
Miami, Florida, United States
Miami, Florida, 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
Camp Hill, Pennsylvania, 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
Fredericksburg, Virginia, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Garran, Australian Capital Territory, Australia
Darlinghurst, New South Wales, 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
Brisbane, Queensland, Australia
Redcliffe, Queensland, Australia
Southport, Queensland, Australia
Woolloongabba, Queensland, Australia
Adelaide, South Australia, Australia
Woodville South, South Australia, Australia
Box Hill, Victoria, Australia
Clayton, Victoria, Australia
Geelong, Victoria, Australia
Melbourne, Victoria, Australia
Melbourne, Victoria, Australia
Fremantle, Western Australia, Australia
Perth, Western Australia, Australia
Graz, Styria, Austria
Vienna, Vienna, Austria
Vienna, Vienna, Austria
Feldkirch, Vorarlberg, Austria
Innsbruck, , Austria
Salzburg, , Austria
Bruxelles - Brussel, , Belgium
Bruxelles - Brussel, , Belgium
Duffel, , Belgium
Genk, , Belgium
Ghent, , Belgium
Hasselt, , Belgium
Leuven, , Belgium
Lier, , Belgium
Liège, , Belgium
Namur, , Belgium
Yvoir, , Belgium
Zottegem, , Belgium
Uberaba, Minas Gerais, Brazil
Curitiba, Paraná, Brazil
Londrina, Paraná, 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
London, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Harbin, Heilongjiang, China
Wuhan, Hubei, China
Suzhou, Jiangsu, China
Shenyang, Liaoning, China
Hangzhou, Zhejiang, China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Karlovy Vary, , Czechia
Kladno, , Czechia
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
Besançon, , 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
Metz-Tessy, , France
Montpellier, , France
Nantes, , France
Nice, , France
Nîmes, , France
Orthez, , France
Paris, , 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
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
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
Wan Chai, , Hong Kong
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Kecskemét, , Hungary
Kistarcsa, , Hungary
Miskolc, , Hungary
Szentes, , Hungary
Szombathely, , Hungary
Kochi, Kerala, India
Mumbai, Maharashtra, India
Hyderabad, , India
Kolkata, , India
New Delhi, , India
Pune, , India
Jakarta, Indonesia, Indonesia
Bandung, , Indonesia
Jakarta, , Indonesia
Medan, , Indonesia
Semarang, , Indonesia
Afula, Israel, Israel
Ashkelon, Israel, Israel
Beersheba, Israel, Israel
Haifa, Israel, Israel
Haifa, Israel, Israel
Haifa, Israel, Israel
Holon, Israel, Israel
Jerusalem, Israel, Israel
Kfar Saba, Israel, Israel
Petah Tikva, Israel, Israel
Rehovot, Israel, Israel
Safed, Israel, Israel
Tel Aviv, Israel, Israel
Bologna, , Italy
Chieti, , Italy
Cremona, , Italy
Milan, , Italy
Milan, , Italy
Milan, , Italy
Napoli, , Italy
Padua, , Italy
Palermo, , Italy
Parma, , Italy
Pavia, , Italy
Piacenza, , Italy
Reggio Emilia, , Italy
Varese, , Italy
Venezia, , Italy
Kuala Selangor, , Malaysia
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
Auckland, , New Zealand
Christchurch, , New Zealand
Palmerston North, , New Zealand
Wellington South, , New Zealand
Fredrikstad, , Norway
Oslo, , Norway
Rud, , Norway
Trondheim, , 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
San Juan, , Puerto Rico
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
Johannesburg, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Cape Town, Western Cape, South Africa
Somerset West, Western Cape, South Africa
Worcester, Western Cape, South Africa
Daegu, Daegu, South Korea
Seoul, Korea, 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
XÃ tiva, Valencia, Spain
Borås, , Sweden
Gothenburg, , Sweden
Gothenburg, , Sweden
Jönköping, , Sweden
Sundsvall, , Sweden
Västervik, , Sweden
Lausanne, Canton of Vaud, Switzerland
Lausanne, Canton of Vaud, Switzerland
Zurich, Canton of Zurich, Switzerland
Genéve 14, Genève 14, Switzerland
Chur, Kanton Graubünden, Switzerland
Lucerne, , Switzerland
Kaosiung, Kaoshiong, Taiwan
Taichung, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Bangkok, Bangkok, Thailand
Pathumwan, Bangkok, Thailand, Thailand
Bangkok, , Thailand
Plymouth, Devon, United Kingdom
Chelmsford, Essex, United Kingdom
Isleworth, Greater London, United Kingdom
London, Greater London, United Kingdom
London, Greater London, United Kingdom
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Prins MH, Lensing AW. Derivation of the non-inferiority margin for the evaluation of direct oral anticoagulants in the treatment of venous thromboembolism. Thromb J. 2013 Jul 6;11(1):13. doi: 10.1186/1477-9560-11-13.
Prins MH, Lensing AW, Bauersachs R, van Bellen B, Bounameaux H, Brighton TA, Cohen AT, Davidson BL, Decousus H, Raskob GE, Berkowitz SD, Wells PS; EINSTEIN Investigators. Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies. Thromb J. 2013 Sep 20;11(1):21. doi: 10.1186/1477-9560-11-21.
Wang Y, Wang C, Chen Z, Zhang J, Liu Z, Jin B, Ying K, Liu C, Shao Y, Jing Z, Meng IL, Prins MH, Pap AF, Muller K, Lensing AW; Chinese EINSTEIN Investigators. Rivaroxaban for the treatment of symptomatic deep-vein thrombosis and pulmonary embolism in Chinese patients: a subgroup analysis of the EINSTEIN DVT and PE studies. Thromb J. 2013 Dec 16;11(1):25. doi: 10.1186/1477-9560-11-25.
Bamber L, Wang MY, Prins MH, Ciniglio C, Bauersachs R, Lensing AW, Cano SJ. Patient-reported treatment satisfaction with oral rivaroxaban versus standard therapy in the treatment of acute symptomatic deep-vein thrombosis. Thromb Haemost. 2013 Oct;110(4):732-41. doi: 10.1160/TH13-03-0243. Epub 2013 Jul 11.
van Bellen B, Bamber L, Correa de Carvalho F, Prins M, Wang M, Lensing AW. Reduction in the length of stay with rivaroxaban as a single-drug regimen for the treatment of deep vein thrombosis and pulmonary embolism. Curr Med Res Opin. 2014 May;30(5):829-37. doi: 10.1185/03007995.2013.879439. Epub 2014 Jan 22.
Cano SJ, Lamping DL, Bamber L, Smith S. The Anti-Clot Treatment Scale (ACTS) in clinical trials: cross-cultural validation in venous thromboembolism patients. Health Qual Life Outcomes. 2012 Sep 26;10:120. doi: 10.1186/1477-7525-10-120.
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.
Yang L, Wu J. Cost-effectiveness of rivaroxaban compared with enoxaparin plus warfarin for the treatment of hospitalised acute deep vein thrombosis in China. BMJ Open. 2020 Jul 30;10(7):e038433. doi: 10.1136/bmjopen-2020-038433.
Ten Cate H, Lensing AWA, Weitz JI, Middeldorp S, Beyer-Westendorf J, Kubitza D, Brighton T, Raskob GE, Mismetti P, Prandoni P, Gebel M, Prins MH. The prothrombin time does not predict the risk of recurrent venous thromboembolism or major bleeding in rivaroxaban-treated patients. Thromb Res. 2018 Oct;170:75-83. doi: 10.1016/j.thromres.2018.08.008. Epub 2018 Aug 15.
Di Nisio M, Vedovati MC, Riera-Mestre A, Prins MH, Mueller K, Cohen AT, Wells PS, Beyer-Westendorf J, Prandoni P, Bounameaux H, Kubitza D, Schneider J, Pisters R, Fedacko J, Fontes-Carvalho R, Lensing AW. Treatment of venous thromboembolism with rivaroxaban in relation to body weight. A sub-analysis of the EINSTEIN DVT/PE studies. Thromb Haemost. 2016 Sep 27;116(4):739-46. doi: 10.1160/TH16-02-0087. Epub 2016 Aug 18.
Prins MH, Lensing AW, Brighton TA, Lyons RM, Rehm J, Trajanovic M, Davidson BL, Beyer-Westendorf J, Pap AF, Berkowitz SD, Cohen AT, Kovacs MJ, Wells PS, Prandoni P. Oral rivaroxaban versus enoxaparin with vitamin K antagonist for the treatment of symptomatic venous thromboembolism in patients with cancer (EINSTEIN-DVT and EINSTEIN-PE): a pooled subgroup analysis of two randomised controlled trials. Lancet Haematol. 2014 Oct;1(1):e37-46. doi: 10.1016/S2352-3026(14)70018-3. Epub 2014 Sep 28.
Bauersachs RM, Lensing AW, Prins MH, Kubitza D, Pap AF, Decousus H, Beyer-Westendorf J, Prandoni P. Rivaroxaban versus enoxaparin/vitamin K antagonist therapy in patients with venous thromboembolism and renal impairment. Thromb J. 2014 Nov 24;12:25. doi: 10.1186/1477-9560-12-25. eCollection 2014.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2006-004495-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
11702b
Identifier Type: OTHER
Identifier Source: secondary_id
11702a
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.