Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism - The EINSTEIN PE Study
2 other identifiers
interventional
4,833
37 countries
282
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2007
Longer than P75 for phase_3
282 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
First Submitted
Initial submission to the registry
February 23, 2007
CompletedFirst Posted
Study publicly available on registry
February 26, 2007
CompletedStudy Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
January 24, 2013
CompletedFebruary 27, 2014
January 1, 2014
4.5 years
February 23, 2007
November 22, 2012
January 25, 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.
3-, 6-, or 12-month study treatment period
Secondary Outcomes (7)
Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment
3-, 6-, or 12-month study treatment period
Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment
3-, 6-, or 12-month study treatment period
Percentage of Participants With Recurrent PE Until the Intended End of Study Treatment
3-, 6- or 12-month study treatment period
Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment
3-, 6- or 12-month study treatment period
Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose)
3-, 6- or 12-month study treatment period
- +2 more secondary outcomes
Other Outcomes (6)
Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment
3-, 6- or 12-month study treatment period
Percentage of Participants With Symptomatic Recurrent VTE (i.e. the Composite of Recurrent DVT or Fatal or Non-fatal PE) During Observational Period
Up to 30 days after the last intake of study medication
Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period
Up to 30 days after the last intake of study medication
- +3 more other outcomes
Study Arms (2)
Rivaroxaban (Xarelto, BAY59-7939)
EXPERIMENTALParticipants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
Enoxaparin/VKA
ACTIVE COMPARATORParticipants 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)
Interventions
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 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
You may qualify if:
- Confirmed acute symptomatic proximal PE with or without symptomatic DVT
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (305)
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Little Rock, Arkansas, 72205, 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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Miami, Florida, 33136-1096, United States
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Miami, Florida, 33136, 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, United States
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Boston, Massachusetts, 02215, United States
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Chesterfield, Missouri, 63017, 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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Camp Hill, Pennsylvania, 17011, United States
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Pittsburgh, Pennsylvania, 15224, 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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Fredericksburg, Virginia, 22401, United States
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Spokane, Washington, 99204, United States
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Tacoma, Washington, 98405, United States
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Les Escaldes, Andorra
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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, 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, 5042, Australia
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Woodville South, South Australia, 5011, Australia
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Launceston, Tasmania, 7250, 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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Fremantle, Western Australia, 6160, Australia
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Perth, Western Australia, 6000, Australia
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Graz, Styria, 8036, Austria
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Vienna, Vienna, 1090, Austria
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Vienna, Vienna, 1140, Austria
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Vienna, Vienna, 1171, Austria
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Feldkirch, Vorarlberg, 6807, Austria
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Innsbruck, 6020, Austria
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Linz, 4010, Austria
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Aalst, 9300, Belgium
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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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Yvoir, 5530, Belgium
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Zottegem, 9620, Belgium
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Curitiba, Paraná, 80050-350, Brazil
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Londrina, Paraná, 86038440, 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, 04039-004, Brazil
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São Paulo, São Paulo, 08270-070, 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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London, Ontario, N6A 4G5, Canada
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Ottawa, Ontario, K1Y 4E9, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M6R 1B5, Canada
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Guangzhou, Guangdong, 510080, China
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Guangzhou, Guangdong, 510120, China
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Guangzhou, Guangdong, China
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Nanning, Guangxi, 530021, 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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Hangzhou, Zhejiang, 310016, 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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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, 150 00, Czechia
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Rakovník, 269 01, 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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Tallinn, 10138, Estonia
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Tampere, 33521, Finland
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Turku, 20520, 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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Besançon, 25000, France
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Bordeaux, 33000, 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, 92701, France
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Dijon, 21000, France
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Grenoble, 38043, France
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Limoges, 87042, France
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Metz-Tessy, 74370, France
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Montpellier, 34295, France
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Nantes, 44000, France
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Nice, 06002, France
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Orthez, 64300, France
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Paris, 75004, France
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Paris, 75015, 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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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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Heidelberg, Baden-Wurttemberg, 69120, Germany
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Karlsbad, Baden-Wurttemberg, 76307, 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, 60590, Germany
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Frankfurt am Main, Hesse, 60596, Germany
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Rotenburg (Wümme), Lower Saxony, 27342, Germany
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Greifswald, Mecklenburg-Vorpommern, 17475, 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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Witten, North Rhine-Westphalia, 58455, Germany
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Mainz, Rhineland-Palatinate, 55131, Germany
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Dresden, Saxony, 01307, 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, 12099, Germany
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Nordhausen, Thuringia, 99734, Germany
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Bottrop, 46242, Germany
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Hong Kong, Hong Kong
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Wan Chai, 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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Szekszárd, 7100, Hungary
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Szentes, 6600, Hungary
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Szombathely, 9700, Hungary
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Zalaegerszeg, 8900, Hungary
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Kochi, Kerala, 682026, India
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Hyderabad, 500082, India
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New Delhi, 110060, India
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Pune, 411001, India
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Jakarta, Indonesia, 10330, Indonesia
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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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Ballinasloe, Co. Galway, Ireland
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Haifa, Israel, 34362, Israel
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Holon, Israel, 58100, Israel
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Jerusalem, Israel, 91120, 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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Haifa, 31048, Israel
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Haifa, 31096, 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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Rozzano, Milano, 20089, Italy
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Bologna, 40138, Italy
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Chieti, 66013, Italy
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Milan, 20122, Italy
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Milan, 20132, Italy
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Milan, 20142, 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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Reggio Emilia, 42100, Italy
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Varese, 21100, Italy
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Venezia, 30122, Italy
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Liepāja, LV 3414, Latvia
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Kaunas, LT-50009, Lithuania
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Vilnius, LT-08661, Lithuania
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Kuala Selangor, 68000, Malaysia
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Amsterdam, 1105 AZ, Netherlands
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Arnhem, 6815 AD, 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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Zwolle, 8025 AB, Netherlands
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Auckland, 0622, New Zealand
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Auckland, 1023, New Zealand
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Auckland, 2024, 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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Rud, 1309, Norway
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Trondheim, 7006, 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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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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Wroclaw, 50-326, Poland
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Wroclaw, 51-124, Poland
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San Juan, 00927, Puerto Rico
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Singapore, 169608, Singapore
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Singapore, 308433, Singapore
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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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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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Seoul, Korea, 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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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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Valladolid, Castille and León, 47010, Spain
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Girona, Girona, 17007, Spain
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Palma de Mallorca, Illes Baleares, 07010, Spain
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Madrid, Madrid, 28034, Spain
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Pamplona, Pamplona, 31008, Spain
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Requena, Valencia, 46340, 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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Stockholm, 118 83, Sweden
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Sundsvall, 851 86, Sweden
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Bern, Canton of Bern, 3010, Switzerland
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Lausanne, Canton of Vaud, 1005, Switzerland
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Lausanne, Canton of Vaud, 1011, 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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Lucerne, 6000, Switzerland
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Taichung, 40705, Taiwan
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Taipei, 10016, Taiwan
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Taipei, 112, Taiwan
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Taipei, 220, Taiwan
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Pathumwan, Bangkok, Thailand, 10330, Thailand
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Bangkok, 10400, Thailand
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Chiang Mai, 50200, Thailand
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Plymouth, Devon, PL6 8DH, 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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London, United Kingdom
Related Publications (12)
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.
PMID: 22449293RESULTPrins 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.
PMID: 23829521RESULTPrins 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.
PMID: 24053656RESULTWang 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.
PMID: 24341332RESULTvan 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.
PMID: 24432872RESULTDobesh 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: 40163217DERIVEDTen 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.
PMID: 30121419DERIVEDDi 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.
PMID: 27535349DERIVEDPrins 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.
PMID: 27030066DERIVEDBauersachs 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.
PMID: 25750589DERIVEDWells 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: 25698905DERIVEDCohen 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: 22371186DERIVED
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
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2007
First Posted
February 26, 2007
Study Start
March 1, 2007
Primary Completion
September 1, 2011
Study Completion
December 1, 2011
Last Updated
February 27, 2014
Results First Posted
January 24, 2013
Record last verified: 2014-01