Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis - The EINSTEIN DVT Study
3 other identifiers
interventional
3,449
33 countries
302
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 DVT without symptomatic PE (Einstein-DVT).
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
Typical duration for phase_3
302 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
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
January 24, 2013
CompletedFebruary 27, 2014
January 1, 2014
3.1 years
February 23, 2007
November 22, 2012
January 26, 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 (6)
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 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
Percentage of Participants With All Deaths
3-, 6- or 12-month study treatment period
- +1 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 Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [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 were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
Enoxaparin/VKA
ACTIVE COMPARATORParticipants 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)
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 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
You may qualify if:
- Confirmed acute symptomatic proximal DVT without symptomatic PE
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 (324)
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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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Albuquerque, New Mexico, 87108-4763, 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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Corsicana, Texas, 75110, United States
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San Antonio, Texas, 78229, United States
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Murray, Utah, 84157, 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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Garran, Australian Capital Territory, 2605, Australia
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Darlinghurst, New South Wales, 2010, 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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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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Feldkirch, Vorarlberg, 6807, Austria
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Innsbruck, 6020, Austria
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Salzburg, 5020, Austria
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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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Uberaba, Minas Gerais, 38010 380, Brazil
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Curitiba, ParanĂ¡, 80050-350, Brazil
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Londrina, ParanĂ¡, 86038440, Brazil
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Botucatu, SĂ£o Paulo, 18618 000, Brazil
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SĂ£o Paulo, SĂ£o Paulo, 01323-001, Brazil
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SĂ£o Paulo, SĂ£o Paulo, 01509-900, Brazil
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SĂ£o Paulo, SĂ£o Paulo, 04023-061, Brazil
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SĂ£o Paulo, SĂ£o Paulo, 04039-004, Brazil
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Sorocaba, SĂ£o 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, 510000, China
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Guangzhou, Guangdong, 510120, 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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Karlovy Vary, 360 00, Czechia
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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, 140 21, Czechia
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Prague, 150 00, 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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Hellerup, 2900, Denmark
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Seinäjoki, 60220, 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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Créteil, 94000, France
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Dijon, 21000, France
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Grenoble, 38028, France
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Grenoble, 38043, France
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Lille, 59037, 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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Nîmes, 30029, 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-BĂ©nite, 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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Tours, 37044, France
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Valenciennes, 59322, France
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VandÅ“uvre-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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Karlsbad, Baden-Wurttemberg, 76307, Germany
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Mannheim, Baden-Wurttemberg, 68167, Germany
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NeckargemĂ¼nd, Baden-Wurttemberg, 69151, Germany
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TĂ¼bingen, Baden-Wurttemberg, 72076, Germany
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Augsburg, Bavaria, 86156, Germany
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MĂ¼nchen, Bavaria, 80331, Germany
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MĂ¼nchen, Bavaria, 81377, Germany
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WĂ¼rzburg, 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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Giessen, Hesse, 35392, Germany
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Wiesbaden, Hesse, 65183, Germany
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Hanover, Lower Saxony, 30625, Germany
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Rotenburg (WĂ¼mme), Lower Saxony, 27342, Germany
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Greifswald, Mecklenburg-Vorpommern, 17475, Germany
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DĂ¼sseldorf, North Rhine-Westphalia, 40225, 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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Soest, North Rhine-Westphalia, 59494, Germany
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Witten, North Rhine-Westphalia, 58455, Germany
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Mainz, Rhineland-Palatinate, 55131, Germany
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Homburg, Saarland, 66421, Germany
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Homburg, Saarland, 66424, Germany
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Dresden, Saxony, 01307, Germany
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Leipzig, Saxony, 04289, 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, 10713, Germany
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Berlin, State of Berlin, 12099, 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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Szentes, 6600, Hungary
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Szombathely, 9700, Hungary
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Kochi, Kerala, 682026, India
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Mumbai, Maharashtra, 400016, India
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Hyderabad, 500082, India
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Kolkata, 700029, 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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Afula, Israel, 18101, Israel
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Ashkelon, Israel, 78306, Israel
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Beersheba, Israel, 84101, Israel
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Haifa, Israel, 31048, Israel
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Haifa, Israel, 31096, Israel
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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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Kfar Saba, Israel, 44281, Israel
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Petah Tikva, Israel, 49100, Israel
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Rehovot, Israel, 76100, Israel
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Safed, Israel, 13100, Israel
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Tel Aviv, Israel, 64239, Israel
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Bologna, 40138, Italy
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Chieti, 66013, Italy
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Cremona, 26100, 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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Napoli, 80131, 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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Kuala Selangor, 68000, Malaysia
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Amsterdam, 1105 AZ, Netherlands
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Arnhem, 6815 AD, Netherlands
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Dordrecht, 3318 AT, 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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Rotterdam, 3083 AN, Netherlands
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Zwijndrecht, 3331 LZ, 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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Bydgoszcz, 85-168, Poland
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Gdansk, 80-952, Poland
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Katowice, 40-365, 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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Warsaw, 02-097, Poland
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Warsaw, 04-479, 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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Cape Town, Cape, 7500, South Africa
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Johannesburg, Gauteng, 1724, South Africa
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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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Johannesburg, Gauteng, 2193, 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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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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Daegu, Daegu, 700721, South Korea
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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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Seoul, 137-701, 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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Girona, Girona, 17007, Spain
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AlcorcĂ³n, Madrid, 28922, Spain
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Fuenlabrada, Madrid, 28942, Spain
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Madrid, Madrid, 28034, Spain
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Pamplona, Pamplona, 31008, Spain
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XĂ tiva, Valencia, 46800, Spain
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BorĂ¥s, 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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Sundsvall, 851 86, Sweden
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Västervik, 593 81, Sweden
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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 GraubĂ¼nden, 7000, Switzerland
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Lucerne, 6000, Switzerland
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Kaosiung, Kaoshiong, 807, Taiwan
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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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Bangkok, Bangkok, 10700, Thailand
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Pathumwan, Bangkok, Thailand, 10330, Thailand
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Bangkok, 10400, Thailand
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Plymouth, Devon, PL6 8DH, United Kingdom
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Chelmsford, Essex, CM1 5ET, United Kingdom
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Isleworth, Greater London, TW7 6AF, United Kingdom
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London, Greater London, SE1 7EH, United Kingdom
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London, Greater London, SE5 9RS, United Kingdom
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London, United Kingdom
Related Publications (15)
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.
PMID: 21128814RESULTCohen 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: 22371186RESULTPrins 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: 24341332RESULTBamber 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.
PMID: 23846019RESULTvan 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: 24432872RESULTCano 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.
PMID: 23013426RESULTDobesh 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: 40163217DERIVEDYang 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.
PMID: 32737096DERIVEDTen 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: 25698905DERIVED
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
April 1, 2010
Study Completion
April 1, 2010
Last Updated
February 27, 2014
Results First Posted
January 24, 2013
Record last verified: 2014-01