Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism - The EINSTEIN PE Study
NCT ID: NCT00439777
Last Updated: 2014-02-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
4833 participants
INTERVENTIONAL
2007-03-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rivaroxaban (Xarelto, BAY59-7939)
Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
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 received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
Enoxaparin overlapping with and 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 hr 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
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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 overlapping with and 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 hr 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
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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
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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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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
Chesterfield, Missouri, 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
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
Les Escaldes, , Andorra
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
Brisbane, Queensland, Australia
Redcliffe, Queensland, Australia
Southport, Queensland, Australia
Woolloongabba, Queensland, Australia
Adelaide, South Australia, Australia
Woodville South, South Australia, Australia
Launceston, Tasmania, 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
Vienna, Vienna, Austria
Feldkirch, Vorarlberg, Austria
Innsbruck, , Austria
Linz, , Austria
Aalst, , Belgium
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
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
Guangzhou, Guangdong, China
Nanning, Guangxi, 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
Kladno, , Czechia
Ostrava, , Czechia
Ostrava-Poruba, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Rakovník, , Czechia
Usti Nad Lebem, , Czechia
Aarhus C, , Denmark
Brædstrup, , Denmark
Frederiksberg, , Denmark
Tallinn, , Estonia
Tampere, , Finland
Turku, , 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
Dijon, , France
Grenoble, , France
Limoges, , France
Metz-Tessy, , France
Montpellier, , France
Nantes, , France
Nice, , 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
Valenciennes, , France
Vandœuvre-lès-Nancy, , France
Vernon, , France
Bruchsal, Baden-Wurttemberg, Germany
Heidelberg, Baden-Wurttemberg, Germany
Heidelberg, Baden-Wurttemberg, Germany
Karlsbad, 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
Rotenburg (Wümme), Lower Saxony, Germany
Greifswald, Mecklenburg-Vorpommern, Germany
Essen, North Rhine-Westphalia, Germany
Paderborn, North Rhine-Westphalia, Germany
Witten, North Rhine-Westphalia, Germany
Mainz, Rhineland-Palatinate, Germany
Dresden, Saxony, Germany
Halle, Saxony-Anhalt, Germany
Magdeburg, Saxony-Anhalt, Germany
Berlin, State of Berlin, Germany
Nordhausen, Thuringia, Germany
Bottrop, , Germany
Hong Kong, , Hong Kong
Wan Chai, , Hong Kong
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Kecskemét, , Hungary
Kistarcsa, , Hungary
Miskolc, , Hungary
Szekszárd, , Hungary
Szentes, , Hungary
Szombathely, , Hungary
Zalaegerszeg, , Hungary
Kochi, Kerala, India
Hyderabad, , India
New Delhi, , India
Pune, , India
Jakarta, Indonesia, Indonesia
Bandung, , Indonesia
Jakarta, , Indonesia
Medan, , Indonesia
Semarang, , Indonesia
Ballinasloe, Co. Galway, Ireland
Haifa, Israel, Israel
Holon, Israel, Israel
Jerusalem, Israel, Israel
Petah Tikva, Israel, Israel
Afula, , Israel
Ashkelon, , Israel
Haifa, , Israel
Haifa, , Israel
Kfar Saba, , Israel
Rehovot, , Israel
Safed, , Israel
Tel Aviv, , Israel
Rozzano, Milano, Italy
Bologna, , Italy
Chieti, , Italy
Milan, , Italy
Milan, , Italy
Milan, , Italy
Padua, , Italy
Palermo, , Italy
Parma, , Italy
Pavia, , Italy
Piacenza, , Italy
Reggio Emilia, , Italy
Varese, , Italy
Venezia, , Italy
Liepāja, , Latvia
Kaunas, , Lithuania
Vilnius, , Lithuania
Kuala Selangor, , Malaysia
Amsterdam, , Netherlands
Arnhem, , Netherlands
Enschede, , Netherlands
Groningen, , Netherlands
Hoofddorp, , Netherlands
Maastricht, , 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
Krakow, , Poland
Lodz, , Poland
Lublin, , Poland
Poznan, , Poland
Poznan, , Poland
Torun, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Wroclaw, , Poland
San Juan, , Puerto Rico
Singapore, , Singapore
Singapore, , Singapore
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
Seoul, Korea, South Korea
Daegu, , South Korea
Seoul, , South Korea
Taegu, , South Korea
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Terrassa, Barcelona, Spain
Valladolid, Castille and León, Spain
Girona, Girona, Spain
Palma de Mallorca, Illes Baleares, Spain
Madrid, Madrid, Spain
Pamplona, Pamplona, Spain
Requena, Valencia, Spain
Borås, , Sweden
Gothenburg, , Sweden
Gothenburg, , Sweden
Jönköping, , Sweden
Stockholm, , Sweden
Sundsvall, , Sweden
Bern, Canton of Bern, Switzerland
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
Taichung, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Pathumwan, Bangkok, Thailand, Thailand
Bangkok, , Thailand
Chiang Mai, , Thailand
Plymouth, Devon, United Kingdom
Isleworth, London, United Kingdom
London, London, United Kingdom
London, London, United Kingdom
London, , United Kingdom
Countries
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References
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EINSTEIN-PE Investigators; Buller HR, Prins MH, Lensin AW, Decousus H, Jacobson BF, Minar E, Chlumsky J, Verhamme P, Wells P, Agnelli G, Cohen A, Berkowitz SD, Bounameaux H, Davidson BL, Misselwitz F, Gallus AS, Raskob GE, Schellong S, Segers A. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012 Apr 5;366(14):1287-97. doi: 10.1056/NEJMoa1113572. Epub 2012 Mar 26.
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.
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.
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.
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.
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.
Other Identifiers
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2006-004495-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
11702b
Identifier Type: -
Identifier Source: org_study_id
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