Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism - The EINSTEIN PE Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00439777

Recruitment Status : Completed

First Posted : February 26, 2007

Results First Posted : January 24, 2013

Last Update Posted : February 27, 2014

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Information provided by (Responsible Party):

Bayer

Study Description

Brief Summary:

This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic pulmonary embolism (PE) with or without symptomatic Deep-Vein Thrombosis (DVT) (Einstein-PE).

Condition or disease	Intervention/treatment	Phase
Pulmonary Embolism	Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Enoxaparin overlapping with and followed by VKA	Phase 3

Detailed Description:

Within the US 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.' is sponsor.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	4833 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism
Study Start Date :	March 2007
Actual Primary Completion Date :	September 2011
Actual Study Completion Date :	December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots Pulmonary Embolism

Drug Information available for: Rivaroxaban Enoxaparin sodium

Genetic and Rare Diseases Information Center resources: Acute Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.)	Drug: 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.
Active Comparator: 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)	Drug: 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.

Outcome Measures

Primary Outcome Measures :

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 [ Time Frame: 3-, 6-, or 12-month study treatment period ]
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.

Secondary Outcome Measures :

Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment [ Time Frame: 3-, 6-, or 12-month study treatment period ]
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 deaths), results/films/images of confirmatory testing, and/or case summaries.
Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment [ Time Frame: 3-, 6-, or 12-month study treatment period ]
Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. 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. Net clinical benefit was considered greater in those participants with fewer composite events. 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.
Percentage of Participants With Recurrent PE Until the Intended End of Study Treatment [ Time Frame: 3-, 6- or 12-month study treatment period ]
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on 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.
Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment [ Time Frame: 3-, 6- or 12-month study treatment period ]
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.
Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose) [ Time Frame: 3-, 6- or 12-month study treatment period ]
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Clinically relevant bleeding included major bleeding (overt bleeding associated with 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) 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 activities of daily life.
Percentage of Participants With All Deaths [ Time Frame: 3-, 6- or 12-month study treatment period ]
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.
Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose) [ Time Frame: 3-, 6- or 12-month study treatment period ]
All pre-defined vascular events (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, unstable angina, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism or vascular death) were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based results/films/images of confirmatory testing, and/or case summaries.

Other Outcome Measures:

Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment [ Time Frame: 3-, 6- or 12-month study treatment period ]
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.
Percentage of Participants With Symptomatic Recurrent VTE (i.e. the Composite of Recurrent DVT or Fatal or Non-fatal PE) During Observational Period [ Time Frame: Up to 30 days after the last intake of study medication ]
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.
Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period [ Time Frame: Up to 30 days after the last intake of study medication ]
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 deaths), results/films/images of confirmatory testing, and/or case summaries.
Percentage of Participants With an Event for Net Clinical Benefit 1 During Observational Period [ Time Frame: Up to 30 days after the last intake of study medication ]
Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. 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. Net clinical benefit was considered greater in those participants with fewer composite events. 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.
Percentage of Participants With Recurrent DVT During Observational Period [ Time Frame: Up to 30 days after the last intake of study medication ]
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.
Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period [ Time Frame: Up to 30 days after the last intake of study medication ]
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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Confirmed acute symptomatic proximal PE with or without symptomatic DVT

Exclusion Criteria:

Legal lower age limitations (country specific)
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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00439777

Locations

Show 305 study locations

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United States, Arkansas

Little Rock, Arkansas, United States, 72205
United States, California

Redlands, California, United States, 92373
United States, Florida

Bay Pines, Florida, United States, 33744

Miami, Florida, United States, 33136-1096

Miami, Florida, United States, 33136
United States, Idaho

Idaho Falls, Idaho, United States, 83404
United States, Louisiana

Covington, Louisiana, United States, 70433
United States, Maryland

Baltimore, Maryland, United States, 21215
United States, Massachusetts

Boston, Massachusetts, United States, 02215
United States, Missouri

Chesterfield, Missouri, United States, 63017
United States, New Mexico

Albuquerque, New Mexico, United States, 87108
United States, North Carolina

Chapel Hill, North Carolina, United States, 27599-7035

Greensboro, North Carolina, United States, 27401

Greensboro, North Carolina, United States, 27403
United States, Oklahoma

Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania

Camp Hill, Pennsylvania, United States, 17011

Pittsburgh, Pennsylvania, United States, 15224
United States, Texas

San Antonio, Texas, United States, 78229
United States, Utah

Murray, Utah, United States, 84107

Salt Lake City, Utah, United States, 84132
United States, Virginia

Fredericksburg, Virginia, United States, 22401
United States, Washington

Spokane, Washington, United States, 99204

Tacoma, Washington, United States, 98405
Andorra

Escaldes - Engordany, Andorra
Australia, Australian Capital Territory

Garran, Australian Capital Territory, Australia, 2605
Australia, New South Wales

Gosford, New South Wales, Australia, 2250

Kogarah, New South Wales, Australia, 2217

Lismore, New South Wales, Australia, 2480

St Leonards, New South Wales, Australia, 2065

Sydney, New South Wales, Australia, 2031

Sydney, New South Wales, Australia, 2139

Sydney, New South Wales, Australia, 2229
Australia, Queensland

Brisbane, Queensland, Australia, 4029

Redcliffe, Queensland, Australia, 4020

Southport, Queensland, Australia, 4215

Woolloongabba, Queensland, Australia, 4102
Australia, South Australia

Adelaide, South Australia, Australia, 5042

Woodville South, South Australia, Australia, 5011
Australia, Tasmania

Launceston, Tasmania, Australia, 7250
Australia, Victoria

Box Hill, Victoria, Australia, 3128

Clayton, Victoria, Australia, 3168

Geelong, Victoria, Australia, 3220

Melbourne, Victoria, Australia, 3135

Melbourne, Victoria, Australia, 3181
Australia, Western Australia

Fremantle, Western Australia, Australia, 6160

Perth, Western Australia, Australia, 6000
Austria

Graz, Steiermark, Austria, 8036

Feldkirch, Vorarlberg, Austria, 6807

Innsbruck, Austria, 6020

Linz, Austria, 4010

Wien, Austria, 1090

Wien, Austria, 1140

Wien, Austria, 1171
Belgium

Aalst, Belgium, 9300

Bruxelles - Brussel, Belgium, 1070

Bruxelles - Brussel, Belgium, 1200

Duffel, Belgium, 2570

Genk, Belgium, 3600

Gent, Belgium, 9000

Hasselt, Belgium, 3500

Leuven, Belgium, 3000

Liege, Belgium, 4000

Lier, Belgium, 2500

Namur, Belgium, 5000

Yvoir, Belgium, 5530

Zottegem, Belgium, 9620
Brazil

Curitiba, Parana, Brazil, 80050-350

Londrina, Parana, Brazil, 86038440

Botucatu, Sao Paulo, Brazil, 18618 000

Sorocaba, Sao Paulo, Brazil, 18031-000

São Paulo, Sao Paulo, Brazil, 01323-001

São Paulo, Sao Paulo, Brazil, 04039-004

São Paulo, Sao Paulo, Brazil, 08270-070

Rio de Janeiro, Brazil

Sao Paulo, Brazil, 01509-900
Canada, Manitoba

Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Ontario

London, Ontario, Canada, N6A 4G5

Ottawa, Ontario, Canada, K1Y 4E9

Toronto, Ontario, Canada, M4N 3M5

Toronto, Ontario, Canada, M6R 1B5
China, Guangdong

Guangzhou, Guangdong, China, 510080

Guangzhou, Guangdong, China, 510120

Guangzhou, Guangdong, China
China, Guangxi

Nanning, Guangxi, China, 530021
China, Heilongjiang

Harbin, Heilongjiang, China, 150086
China, Hubei

Wuhan, Hubei, China, 430022
China, Jiangsu

Suzhou, Jiangsu, China, 215004
China, Liaoning

Shenyang, Liaoning, China, 110016
China, Zhejiang

Hangzhou, Zhejiang, China, 310016
China

Beijing, China, 100020

Beijing, China, 100029

Beijing, China, 100037

Beijing, China, 100038

Beijing, China, 100044

Beijing, China, 100730

Beijing, China, 100853

Shanghai, China, 200001

Shanghai, China, 200032

Shanghai, China, 200433
Czech Republic

Kladno, Czech Republic, 27259

Ostrava-Poruba, Czech Republic, 708 52

Ostrava, Czech Republic, 728 80

Prague 5, Czech Republic, 150 00

Praha 1, Czech Republic, 110 00

Praha 2, Czech Republic, 12800

Rakovnik, Czech Republic, 269 01

Usti nad Lebem, Czech Republic, 401 13
Denmark

Aarhus C, Denmark, 8000

Braedstrup, Denmark, 8740

Frederiksberg, Denmark, 2000F
Estonia

Tallinn, Estonia, 10138
Finland

Tampere, Finland, 33521

Turku, Finland, 20520
France

Agen Cedex 9, France, 47923

Amiens, France, 80000

Angers Cedex 01, France, 49033

Arras, France, 62000

Besancon, France, 25000

Bordeaux, France, 33000

Brest Cedex, France, 29609

Castelnau Le Lez, France, 34170

Clamart, France, 92141

Clermont Ferrand, France, 63000

Colombes Cedex, France, 92701

Dijon, France, 21000

Grenoble, France, 38043

Limoges, France, 87042

Metz-tessy, France, 74370

Montpellier Cedex, France, 34295

Nantes, France, 44000

Nice, France, 06002

Orthez, France, 64300

Paris Cedex 15, France, 75908

Paris, France, 75004

Paris, France, 75015

Paris, France, 75475

Paris, France, 75877

Pierre Benite, France, 69495

Roanne, France, 42328

Rouen Cedex, France, 76031

Saint Etienne, France, 42055

Strasbourg Cedex, France, 67091

Toulon, France, 83000

Toulouse, France, 31403

Valenciennes Cedex, France, 59322

Vandoeuvre Les Nancy, France, 54511

Vernon, France, 27200
Germany

Bruchsal, Baden-Württemberg, Germany, 76646

Heidelberg, Baden-Württemberg, Germany, 69115

Heidelberg, Baden-Württemberg, Germany, 69120

Karlsbad, Baden-Württemberg, Germany, 76307

Neckargemünd, Baden-Württemberg, Germany, 69151

Tübingen, Baden-Württemberg, Germany, 72076

Augsburg, Bayern, Germany, 86156

München, Bayern, Germany, 80331

München, Bayern, Germany, 81377

Würzburg, Bayern, Germany, 97080

Darmstadt, Hessen, Germany, 64297

Frankfurt, Hessen, Germany, 60590

Frankfurt, Hessen, Germany, 60596

Greifswald, Mecklenburg-Vorpommern, Germany, 17475

Rotenburg, Niedersachsen, Germany, 27342

Essen, Nordrhein-Westfalen, Germany, 45122

Paderborn, Nordrhein-Westfalen, Germany, 33098

Witten, Nordrhein-Westfalen, Germany, 58455

Mainz, Rheinland-Pfalz, Germany, 55131

Halle, Sachsen-Anhalt, Germany, 06120

Magdeburg, Sachsen-Anhalt, Germany, 39112

Dresden, Sachsen, Germany, 01307

Nordhausen, Thüringen, Germany, 99734

Berlin, Germany, 12099

Bottrop, Germany, 46242

Hamburg, Germany, 20251
Hong Kong

Hong Kong, Hong Kong

Wanchai, Hong Kong
Hungary

Budapest, Hungary, 1096

Budapest, Hungary, 1115

Debrecen, Hungary, 4032

Kecskemet, Hungary, 6000

Kistarcsa, Hungary, 2143

Miskolc, Hungary, 3526

Szekszard, Hungary, 7100

Szentes, Hungary, 6600

Szombathely, Hungary, 9700

Zalaegerszeg, Hungary, 8900
India

Kochi, Kerala, India, 682026

Hyderabad, India, 500082

New Delhi, India, 110060

Pune, India, 411001
Indonesia

Bandung, Indonesia, 40161

Jakarta, Indonesia, 10330

Jakarta, Indonesia, 10430

Medan, Indonesia, 20152

Semarang, Indonesia, 50241
Ireland

Ballinasloe, Co. Galway, Ireland
Israel

Afula, Israel, 18101

Ashkelon, Israel, 78278

Haifa, Israel, 31048

Haifa, Israel, 31096

Haifa, Israel, 34362

Holon, Israel, 58100

Jerusalem, Israel, 91120

Kfar Saba, Israel, 44281

Petach Tikva, Israel, 49100

Rehovot, Israel, 76100

Safed, Israel, 13100

Tel Aviv, Israel, 64239
Italy

Rozzano, Milano, Italy, 20089

Bologna, Italy, 40138

Chieti, Italy, 66013

Milano, Italy, 20122

Milano, Italy, 20132

Milano, Italy, 20142

Padova, Italy, 35128

Palermo, Italy, 90127

Parma, Italy, 43100

Pavia, Italy, 27100

Piacenza, Italy, 29100

Reggio Emilia, Italy, 42100

Varese, Italy, 21100

Venezia, Italy, 30122
Korea, Republic of

Seoul, Korea, Korea, Republic of, 110-744

Daegu, Korea, Republic of, 705-718

Seoul, Korea, Republic of, 120-752

Taegu, Korea, Republic of, 700-712
Latvia

Liepaja, Latvia, LV 3414
Lithuania

Kaunas, Lithuania, LT-50009

Vilnius, Lithuania, LT-08661
Malaysia

Selangor, Malaysia, 68000
Netherlands

Amsterdam, Netherlands, 1105 AZ

Arnhem, Netherlands, 6815 AD

Enschede, Netherlands, 7511 JX

Groningen, Netherlands, 9713 GZ

Hoofddorp, Netherlands, 2134 TM

Maastricht, Netherlands, 6229 HX

Zwolle, Netherlands, 8025 AB
New Zealand

Auckland, New Zealand, 0622

Auckland, New Zealand, 1023

Auckland, New Zealand, 2024

Christchurch, New Zealand, 8011

Palmerston North, New Zealand, 4414

Wellington South, New Zealand, 6021
Norway

Fredrikstad, Norway, 1603

Oslo, Norway, 0407

Rud, Norway, 1309

Trondheim, Norway, 7006
Philippines

Quezon City, Philippines, 0850

Quezon City, Philippines, 1102
Poland

Bialystok, Poland, 15-276

Krakow, Poland, 31-066

Lodz, Poland, 90-153

Lublin, Poland, 20-081

Poznan, Poland, 60-631

Poznan, Poland, 61-848

Torun, Poland, 87-100

Warszawa, Poland, 01-138

Wroclaw, Poland, 50-326

Wroclaw, Poland, 51-124
Puerto Rico

San Juan, Puerto Rico, 00927
Singapore

Singapore, Singapore, 169608

Singapore, Singapore, 308433
South Africa

Johannesburg, Gauteng, South Africa, 2132

Johannesburg, Gauteng, South Africa, 2157

Johannesburg, Gauteng, South Africa, 2191

Pretoria, Gauteng, South Africa, 0084

Pretoria, Gauteng, South Africa, 0157

Pretoria, Gauteng, South Africa, 0181

Roodepoort, Gauteng, South Africa, 1724

Cape Town, Western Cape, South Africa, 7460

Somerset West, Western Cape, South Africa, 7130

Worcester, Western Cape, South Africa, 6850
Spain

Terrassa, Barcelona, Spain, 08221

Valladolid, Castilla - León, Spain, 47010

Palma de Mallorca, Illes Baleares, Spain, 07010

Requena, Valencia, Spain, 46340

Barcelona, Spain, 08025

Barcelona, Spain, 08036

Girona, Spain, 17007

Madrid, Spain, 28034

Pamplona, Spain, 31008
Sweden

Borås, Sweden, 501 82

Göteborg, Sweden, 413 45

Göteborg, Sweden, 416 85

Jönköping, Sweden, 551 85

Stockholm, Sweden, 118 83

Sundsvall, Sweden, 851 86
Switzerland

Genéve 14, Genève 14, Switzerland, 1211

Chur, Graubünden, Switzerland, 7000

Lausanne, Vaud, Switzerland, 1011

Lausanne, Waadt, Switzerland, 1005

Bern, Switzerland, 3010

Luzern, Switzerland, 6000

Zürich, Switzerland, 8091
Taiwan

Taichung, Taiwan, 40705

Taipei, Taiwan, 10016

Taipei, Taiwan, 112

Taipei, Taiwan, 220
Thailand

Bangkok, Thailand, 10400

Chiang Mai, Thailand, 50200

Pathumwan, Bangkok, Thailand, 10330
United Kingdom

Plymouth, Devon, United Kingdom, PL6 8DH

Isleworth, London, United Kingdom, TW7 6AF

London, United Kingdom, SE1 7EH

London, United Kingdom, SE5 9RS

London, United Kingdom

Sponsors and Collaborators

Bayer

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

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Study Director:	Bayer Study Director	Bayer

More Information

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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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.

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Responsible Party:	Bayer
ClinicalTrials.gov Identifier:	NCT00439777
Other Study ID Numbers:	11702b 2006-004495-13 ( EudraCT Number )
First Posted:	February 26, 2007 Key Record Dates
Results First Posted:	January 24, 2013
Last Update Posted:	February 27, 2014
Last Verified:	January 2014

Additional relevant MeSH terms:

Layout table for MeSH terms

Pulmonary Embolism Embolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Enoxaparin Rivaroxaban	Factor Xa Inhibitors Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents

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