Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic VTE(Venous Thromboembolism)
EinsteinChoice
Reduced-dosed Rivaroxaban and Standard-dosed Rivaroxaban Versus ASA in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis and/or Pulmonary Embolism
2 other identifiers
interventional
3,365
30 countries
254
Brief Summary
This is a multicenter, randomized, double-blind, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (Deep Vein Thrombosis) or PE (Pulmonary embolism) who completed 6 or 12 months of treatment of anticoagulation are eligible for this trial
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 2014
Typical duration for phase_3
254 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 14, 2014
CompletedFirst Posted
Study publicly available on registry
February 17, 2014
CompletedStudy Start
First participant enrolled
March 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 4, 2016
CompletedResults Posted
Study results publicly available
December 19, 2017
CompletedDecember 19, 2017
November 1, 2017
2.6 years
February 14, 2014
September 12, 2017
December 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism
The primary efficacy outcomes (i.e., recurrent venous thromboembolism \[VTE\] defined as composite of fatal or non-fatal symptomatic recurrent VTE, including unexplained death for which pulmonary embolism \[PE\] could not be ruled out) as confirmed by the central independent adjudication committee (CIAC) were considered up to the end of the individual intended duration of treatment. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.
Up to 12 months, at least 6 months
Number of Participants With First Treatment-emergent Major Bleeding
The principal safety outcome was major bleeding which was defined according to the criteria of the International Society on Thrombosis and Hemostasis (ISTH) as clinically overt bleeding and associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra articular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.
Up to 12 months, at least 6 months
Secondary Outcomes (2)
Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism
Up to 12 months, at least 6 months
Number of Participants With Non-major Bleeding Associated With Study Drug Interruption for > 14 Days
Up to 12 months, at least 6 months
Study Arms (3)
Arm 1
EXPERIMENTALRivaroxaban 10 mg once daily for 12 months
Arm 2
EXPERIMENTALRivaroxaban 20 mg once daily for 12 months
Arm 3
ACTIVE COMPARATORASA (Acetylsalicylic Acid) 100 mg once daily for 12 months
Interventions
Eligibility Criteria
You may qualify if:
- Patients with confirmed symptomatic PE and/or DVT who have been treated for 6 to 12 months and did not interrupt anticoagulation for longer than 1 week
You may not qualify if:
- Legal lower age limitations (country specific) Indication for therapeutic-dosed anticoagulants Indication for antiplatelet therapy or a conventional non-steroid anti-inflammatory drug (NSAID) Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk Calculated creatinine clearance \< 30 mL/min
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Janssen Scientific Affairs, LLCcollaborator
Study Sites (266)
Unknown Facility
Beverly Hills, California, 90211, United States
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La Jolla, California, 92037, United States
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Ventura, California, 93003, United States
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Denver, Colorado, 80262, United States
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Jacksonville, Florida, 32207, United States
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Columbus, Georgia, 31904, United States
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Joliet, Illinois, 60435, United States
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Rockport, Maine, 04856, United States
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Boston, Massachusetts, 02114-2696, United States
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Boston, Massachusetts, 02115, United States
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Boston, Massachusetts, 02215, United States
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Detroit, Michigan, 48202, United States
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Butte, Montana, 59701, United States
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Las Vegas, Nevada, 89169, United States
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Raleigh, North Carolina, 27607, United States
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Columbus, Ohio, 43210-1240, United States
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Toledo, Ohio, 43606, United States
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Philadelphia, Pennsylvania, 19104, United States
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San Antonio, Texas, 78229, United States
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Fredericksburg, Virginia, 22401, United States
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Bellevue, Washington, 98004, United States
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Seattle, Washington, 98104, United States
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Spokane, Washington, 99216, United States
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Tacoma, Washington, 98405-2433, United States
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Garran, Australian Capital Territory, 2605, Australia
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Concord, New South Wales, 2139, 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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Randwick, New South Wales, 2031, Australia
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St Leonards, New South Wales, 2065, Australia
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Westmead, New South Wales, 2145, Australia
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Brisbane, Queensland, 4029, Australia
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Clayton, Victoria, 3168, Australia
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Box Hill, 3128, Australia
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Melbourne, 3004, Australia
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Redcliffe, 4020, Australia
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Graz, Styria, 8036, Austria
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Innsbruck, Tyrol, 6020, Austria
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Vienna, 1090, 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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Hasselt, 3500, Belgium
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Leuven, 3000, Belgium
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Belo Horizonte, Minas Gerais, 30150-221, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Campinas, São Paulo, 13083-970, Brazil
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Santo André, São Paulo, 09060-650, Brazil
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Santo André, São Paulo, 09190-615, Brazil
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São Paulo, São Paulo, 01323-001, Brazil
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São Paulo, São Paulo, 04039-004, Brazil
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Rio de Janeiro, Brazil
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São Paulo, 05403-900, Brazil
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Edmonton, Alberta, T6G 2B7, Canada
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Victoria, British Columbia, V8R 4R2, Canada
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Saint John, New Brunswick, E2L 4L2, Canada
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Halifax, Nova Scotia, B3H 3A7, Canada
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Hamilton, Ontario, L8L 2X2, Canada
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Hamilton, Ontario, L8N 4A6, Canada
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Hamilton, Ontario, L8V 1C3, Canada
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London, Ontario, N6A 4G5, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Montreal, Quebec, H3T 1M5, Canada
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Saint-Jérôme, Quebec, J7Z 5T3, Canada
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Fuzhou, Fujian, 350025, China
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Guangzhou, Guangdong, 510080, China
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Guangzhou, Guangdong, 510120, China
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Nanning, Guangxi, 530021, China
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Shijiazhuang, Hebei, 050000, China
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Harbin, Heilongjiang, China
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Wuhan, Hubei, 430032, China
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Changsha, Hunan, 410011, China
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Changsha, Hunan, 410013, China
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Nantong, Jiangsu, 226001, China
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Suzhou, Jiangsu, 215004, China
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Changchun, Jilin, 130000, China
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Shengyang, Liaoning, 110004, China
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Shenyang, Liaoning, 110001, China
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Yinchuan, Ningxia, 750004, China
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Xi'an, Shaanxi, 710032, China
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Xi'an, Shaanxi, 710061, China
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Jinan, Shandong, 250012, China
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Qingdao, Shandong, 266000, China
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Taiyuan, Shanxi, 030001, China
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Chengdu, Sichuan, 610041, China
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Kunming, Yunnan, 650032, China
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Hangzhou, Zhejiang, 310003, China
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Hangzhou, Zhejiang, 310016, China
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Wenzhou, Zhejiang, 325000, 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, 100053, China
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Beijing, 100730, China
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Shanghai, 200001, China
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Shanghai, 200025, China
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Shanghai, 200032, China
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Shanghai, 200233, China
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Shanghai, 200433, China
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Tianjin, 300052, China
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Tianjin, 300121, China
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Tianjin, 300211, China
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Kladno, 27259, Czechia
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Liberec, 46063, Czechia
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Litomyšl, 570 14, Czechia
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Ostrava, 708 52, Czechia
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Ostrava, 728 80, Czechia
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Prague, 110 00, Czechia
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Prague, 118 33, Czechia
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Prague, 150 06, Czechia
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Ústí nad Labem, 401 13, Czechia
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Aarhus N, 8200, Denmark
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Copenhagen, 2300, Denmark
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Glostrup Municipality, 2600, Denmark
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Hellerup, 2900, Denmark
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Herning, 7400, Denmark
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København NV, 2400, Denmark
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Svendborg, 5700, Denmark
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Angers, 49933, France
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Arras, 62000, France
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Besançon, 25030, France
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Bois-Guillaume, 76320, France
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Brest, 29240, France
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Brest, 29609, France
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Castelnau-le-Lez, 34170, 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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Le Kremlin-Bicêtre, 94275, France
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Le Mans, 72037, France
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Limoges, 87042, France
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Nice, 06002, France
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Paris, 75475, France
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Paris, 75674, France
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Paris, 75908, France
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Quimper, 29000, France
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Saint-Etienne, 42055, France
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Strasbourg, 67091, France
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Toulon, 83056, France
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Toulouse, 31403, France
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Vernon, 27200, France
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Heidelberg, Baden-Wurttemberg, 69120, Germany
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München, Bavaria, 80336, Germany
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Darmstadt, Hesse, 64297, Germany
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Witten, North Rhine-Westphalia, 58448, Germany
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Mainz, Rhineland-Palatinate, 55131, Germany
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Dresden, Saxony, 01067, Germany
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Dresden, Saxony, 01307, Germany
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Magdeburg, Saxony-Anhalt, 39112, Germany
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Erfurt, Thuringia, 99089, Germany
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Berlin, 10787, Germany
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Karlsbad, 76307, Germany
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Baja, 6500, Hungary
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Budapest, 1115, Hungary
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Debrecen, 4032, Hungary
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Gyula, 5700, Hungary
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Kecskemét, 6000, Hungary
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Miskolc, 3526, Hungary
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Pécs, 7624, 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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Afula, 1834111, Israel
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Haifa, 3109601, Israel
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Haifa, 3339419, Israel
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Holon, 5810001, Israel
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Kfar Saba, 4428164, Israel
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Nahariya, 2210001, Israel
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Petah Tikva, 4941492, Israel
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Safed, 1311001, Israel
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Tel Aviv, 64239, Israel
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Chieti, Abruzzo, 66013, Italy
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Cosenza, Calabria, 87100, Italy
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Piacenza, Emilia-Romagna, 29121, Italy
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Reggio Emilia, Emilia-Romagna, 42100, Italy
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Varese, Lombardy, 21100, Italy
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Perugia, Umbria, 06156, Italy
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Padua, Veneto, 35128, Italy
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Treviso, Veneto, 31029, Italy
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Treviso, Veneto, 31033, Italy
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León, Guanajuato, 37000, Mexico
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Guadalajara, Jalisco, 44280, Mexico
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Guadalajara, Jalisco, 44340, Mexico
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Monterrey, Nuevo León, 64718, Mexico
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Xalapa, Veracruz, 91020, Mexico
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Mérida, Yucatán, 97129, Mexico
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Aguascalientes, 20230, Mexico
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Chihuahua City, 31203, Mexico
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Alkmaar, 1815 JD, Netherlands
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Almere Stad, 1315 RA, Netherlands
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Amsterdam, 1105 AZ, Netherlands
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Assen, 9401 RK, Netherlands
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Dordrecht, 3318 AT, 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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Sittard, 6131 BK, Netherlands
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Zwolle, 8025 AB, Netherlands
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Auckland, 1023, New Zealand
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Auckland, 1309, 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, 6021, New Zealand
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Fredrikstad, 1603, Norway
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Oslo, 0450, Norway
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Quezon City, NCR 1100, Philippines
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Bialystok, 15-276, Poland
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Bydgoszcz, 85-681, Poland
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Poznan, 60-631, Poland
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Warsaw, 01-138, Poland
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Wroclaw, 51-124, Poland
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Barnaul, 656045, Russia
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Moscow, 111539, Russia
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Moscow, 121552, Russia
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Novosibirsk, 630055, Russia
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Novosibirsk, 630087, Russia
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Rostov-on-Don, 344022, Russia
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Ryazan, 390026, Russia
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Saint Petersburg, 197022, Russia
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Saint Petersburg, Russia
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Sochi, 354057, Russia
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Tver', 170036, Russia
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Johannesburg, Gauteng, 2132, South Africa
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Johannesburg, Gauteng, 2191, South Africa
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Pretoria, Gauteng, 0181, South Africa
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Pretoria West, Gauteng, 0082, South Africa
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Roodepoort, Gauteng, 1724, South Africa
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Worcester, Western Cape, 6850, South Africa
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Bloemfontein, 9301, South Africa
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Donggu, Gwangju Gwang''yeogsi, 501-757, South Korea
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Busan, 602-739, South Korea
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Daegu, 705-718, South Korea
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Seoul, 03080, South Korea
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Seoul, 120-752, South Korea
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Seoul, 135-710, South Korea
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Torrevieja, Alicante, 03186, Spain
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L'Hospitalet de Llobregat, Barcelona, 08907, Spain
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San Sebastián de los Reyes, Madrid, 28702, Spain
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Girona, 17007, Spain
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Madrid, 28007, Spain
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Gothenburg, 416 85, Sweden
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Kristianstad, 29185, Sweden
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Basel, Canton of Basel-City, 4031, Switzerland
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Lausanne, Canton of Vaud, 1011, Switzerland
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Bern, 3010, Switzerland
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Fribourg, 1700, Switzerland
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Geneva, 1205, Switzerland
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Lucerne, 6000, Switzerland
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New Taipei City, 220, Taiwan
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Taichung, 40447, Taiwan
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Taipei, 11217, Taiwan
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Bangkok, 10400, Thailand
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Khon Kaen, 40002, Thailand
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Istanbul, 34-300, Turkey (Türkiye)
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Istanbul, 34760, Turkey (Türkiye)
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Plymouth, Devon, PL6 8DH, United Kingdom
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Hull, Humberside, HU3 2JZ, United Kingdom
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Newcastle upon Tyne, Tyne and Wear, NE1 4LP, United Kingdom
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Cardiff, CF14 4XW, United Kingdom
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London, SE1 7EH, United Kingdom
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Hà Nội, Vietnam
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Ho Chi Minh City, 70000, Vietnam
Related Publications (5)
Weitz JI, Bauersachs R, Beyer-Westendorf J, Bounameaux H, Brighton TA, Cohen AT, Davidson BL, Holberg G, Kakkar A, Lensing AW, Prins M, Haskell L, van Bellen B, Verhamme P, Wells PS, Prandoni P; EINSTEIN CHOICE Investigators. Two doses of rivaroxaban versus aspirin for prevention of recurrent venous thromboembolism. Rationale for and design of the EINSTEIN CHOICE study. Thromb Haemost. 2015 Aug 31;114(3):645-50. doi: 10.1160/TH15-02-0131. Epub 2015 May 21.
PMID: 25994838BACKGROUNDDobesh 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: 40163217DERIVEDYamada N, Fu W, Shi Z, Park KH, Kim HS, Dai X, Lensing AW, Pap AF, Kohno T, Tajima T, Watakabe T, Mitsumori T. Risk of recurrent venous thromboembolism and major bleeding according to risk factor profiles in Asian patients: a subgroup analysis EINSTEIN-Extension and EINSTEIN-CHOICE. Thromb J. 2024 Jun 6;22(1):48. doi: 10.1186/s12959-024-00609-4.
PMID: 38844941DERIVEDFlumignan CD, Nakano LC, Baptista-Silva JC, Flumignan RL. Antiplatelet agents for the treatment of deep venous thrombosis. Cochrane Database Syst Rev. 2022 Jul 25;7(7):CD012369. doi: 10.1002/14651858.CD012369.pub2.
PMID: 35876829DERIVEDWeitz JI, Lensing AWA, Prins MH, Bauersachs R, Beyer-Westendorf J, Bounameaux H, Brighton TA, Cohen AT, Davidson BL, Decousus H, Freitas MCS, Holberg G, Kakkar AK, Haskell L, van Bellen B, Pap AF, Berkowitz SD, Verhamme P, Wells PS, Prandoni P; EINSTEIN CHOICE Investigators. Rivaroxaban or Aspirin for Extended Treatment of Venous Thromboembolism. N Engl J Med. 2017 Mar 30;376(13):1211-1222. doi: 10.1056/NEJMoa1700518. Epub 2017 Mar 18.
PMID: 28316279DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Bayer AG
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2014
First Posted
February 17, 2014
Study Start
March 5, 2014
Primary Completion
September 22, 2016
Study Completion
November 4, 2016
Last Updated
December 19, 2017
Results First Posted
December 19, 2017
Record last verified: 2017-11