Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic VTE(Venous Thromboembolism)
NCT ID: NCT02064439
Last Updated: 2017-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3365 participants
INTERVENTIONAL
2014-03-05
2016-11-04
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Arm 1
Rivaroxaban 10 mg once daily for 12 months
BAY 59-7939
10 mg tablet once daily for 12 months
Arm 2
Rivaroxaban 20 mg once daily for 12 months
BAY 59-7939
20 mg tablet once daily for 12 months
Arm 3
ASA (Acetylsalicylic Acid) 100 mg once daily for 12 months
ASA
100 mg tablet once daily for 12 months
Interventions
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BAY 59-7939
10 mg tablet once daily for 12 months
BAY 59-7939
20 mg tablet once daily for 12 months
ASA
100 mg tablet once daily for 12 months
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Janssen Scientific Affairs, LLC
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Beverly Hills, California, United States
La Jolla, California, United States
Ventura, California, United States
Denver, Colorado, United States
Jacksonville, Florida, United States
Columbus, Georgia, United States
Joliet, Illinois, United States
Rockport, Maine, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Butte, Montana, United States
Las Vegas, Nevada, United States
Raleigh, North Carolina, United States
Columbus, Ohio, United States
Toledo, Ohio, United States
Philadelphia, Pennsylvania, United States
San Antonio, Texas, United States
Fredericksburg, Virginia, United States
Bellevue, Washington, United States
Seattle, Washington, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Garran, Australian Capital Territory, Australia
Concord, New South Wales, Australia
Kogarah, New South Wales, Australia
Lismore, New South Wales, Australia
Randwick, New South Wales, Australia
St Leonards, New South Wales, Australia
Westmead, New South Wales, Australia
Brisbane, Queensland, Australia
Clayton, Victoria, Australia
Box Hill, , Australia
Melbourne, , Australia
Redcliffe, , Australia
Graz, Styria, Austria
Innsbruck, Tyrol, Austria
Vienna, , Austria
Aalst, , Belgium
Bruxelles - Brussel, , Belgium
Bruxelles - Brussel, , Belgium
Hasselt, , Belgium
Leuven, , Belgium
Belo Horizonte, Minas Gerais, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Campinas, São Paulo, Brazil
Santo André, São Paulo, Brazil
Santo André, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Rio de Janeiro, , Brazil
São Paulo, , Brazil
Edmonton, Alberta, Canada
Victoria, British Columbia, Canada
Saint John, New Brunswick, Canada
Halifax, Nova Scotia, Canada
Hamilton, Ontario, Canada
Hamilton, Ontario, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
Ottawa, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Saint-Jérôme, Quebec, Canada
Fuzhou, Fujian, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Nanning, Guangxi, China
Shijiazhuang, Hebei, China
Harbin, Heilongjiang, China
Wuhan, Hubei, China
Changsha, Hunan, China
Changsha, Hunan, China
Nantong, Jiangsu, China
Suzhou, Jiangsu, China
Changchun, Jilin, China
Shengyang, Liaoning, China
Shenyang, Liaoning, China
Yinchuan, Ningxia, China
Xi'an, Shaanxi, China
Xi'an, Shaanxi, China
Jinan, Shandong, China
Qingdao, Shandong, China
Taiyuan, Shanxi, China
Chengdu, Sichuan, China
Kunming, Yunnan, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Wenzhou, Zhejiang, China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Tianjin, , China
Tianjin, , China
Tianjin, , China
Kladno, , Czechia
Liberec, , Czechia
Litomyšl, , Czechia
Ostrava, , Czechia
Ostrava, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Ústí nad Labem, , Czechia
Aarhus N, , Denmark
Copenhagen, , Denmark
Glostrup Municipality, , Denmark
Hellerup, , Denmark
Herning, , Denmark
København NV, , Denmark
Svendborg, , Denmark
Angers, , France
Arras, , France
Besançon, , France
Bois-Guillaume, , France
Brest, , France
Brest, , France
Castelnau-le-Lez, , France
Clermont-Ferrand, , France
Colombes, , France
Dijon, , France
Grenoble, , France
Le Kremlin-Bicêtre, , France
Le Mans, , France
Limoges, , France
Nice, , France
Paris, , France
Paris, , France
Paris, , France
Quimper, , France
Saint-Etienne, , France
Strasbourg, , France
Toulon, , France
Toulouse, , France
Vernon, , France
Heidelberg, Baden-Wurttemberg, Germany
München, Bavaria, Germany
Darmstadt, Hesse, Germany
Witten, North Rhine-Westphalia, Germany
Mainz, Rhineland-Palatinate, Germany
Dresden, Saxony, Germany
Dresden, Saxony, Germany
Magdeburg, Saxony-Anhalt, Germany
Erfurt, Thuringia, Germany
Berlin, , Germany
Karlsbad, , Germany
Baja, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Gyula, , Hungary
Kecskemét, , Hungary
Miskolc, , Hungary
Pécs, , Hungary
Szentes, , Hungary
Szombathely, , Hungary
Zalaegerszeg, , Hungary
Afula, , Israel
Haifa, , Israel
Haifa, , Israel
Holon, , Israel
Kfar Saba, , Israel
Nahariya, , Israel
Petah Tikva, , Israel
Safed, , Israel
Tel Aviv, , Israel
Chieti, Abruzzo, Italy
Cosenza, Calabria, Italy
Piacenza, Emilia-Romagna, Italy
Reggio Emilia, Emilia-Romagna, Italy
Varese, Lombardy, Italy
Perugia, Umbria, Italy
Padua, Veneto, Italy
Treviso, Veneto, Italy
Treviso, Veneto, Italy
León, Guanajuato, Mexico
Guadalajara, Jalisco, Mexico
Guadalajara, Jalisco, Mexico
Monterrey, Nuevo León, Mexico
Xalapa, Veracruz, Mexico
Mérida, Yucatán, Mexico
Aguascalientes, , Mexico
Chihuahua City, , Mexico
Alkmaar, , Netherlands
Almere Stad, , Netherlands
Amsterdam, , Netherlands
Assen, , Netherlands
Dordrecht, , Netherlands
Groningen, , Netherlands
Hoofddorp, , Netherlands
Maastricht, , Netherlands
Sittard, , Netherlands
Zwolle, , Netherlands
Auckland, , New Zealand
Auckland, , New Zealand
Auckland, , New Zealand
Christchurch, , New Zealand
Palmerston North, , New Zealand
Wellington, , New Zealand
Fredrikstad, , Norway
Oslo, , Norway
Quezon City, , Philippines
Bialystok, , Poland
Bydgoszcz, , Poland
Poznan, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Barnaul, , Russia
Moscow, , Russia
Moscow, , Russia
Novosibirsk, , Russia
Novosibirsk, , Russia
Rostov-on-Don, , Russia
Ryazan, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Sochi, , Russia
Tver', , Russia
Johannesburg, Gauteng, South Africa
Johannesburg, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Pretoria West, Gauteng, South Africa
Roodepoort, Gauteng, South Africa
Worcester, Western Cape, South Africa
Bloemfontein, , South Africa
Donggu, Gwangju Gwang''yeogsi, South Korea
Busan, , South Korea
Daegu, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Torrevieja, Alicante, Spain
L'Hospitalet de Llobregat, Barcelona, Spain
San Sebastián de los Reyes, Madrid, Spain
Girona, , Spain
Madrid, , Spain
Gothenburg, , Sweden
Kristianstad, , Sweden
Basel, Canton of Basel-City, Switzerland
Lausanne, Canton of Vaud, Switzerland
Bern, , Switzerland
Fribourg, , Switzerland
Geneva, , Switzerland
Lucerne, , Switzerland
New Taipei City, , Taiwan
Taichung, , Taiwan
Taipei, , Taiwan
Bangkok, , Thailand
Khon Kaen, , Thailand
Istanbul, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Plymouth, Devon, United Kingdom
Hull, Humberside, United Kingdom
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Cardiff, , United Kingdom
London, , United Kingdom
Hà Nội, , Vietnam
Ho Chi Minh City, , Vietnam
Countries
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References
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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.
Dobesh PP, Volkl AA, Pap AF, Damaraju CV, Levitan B, Yuan Z, Amin AN. Benefit-Risk Assessment of Rivaroxaban in Older Patients With Nonvalvular Atrial Fibrillation or Venous Thromboembolism. Drugs Aging. 2025 May;42(5):469-484. doi: 10.1007/s40266-025-01192-7. Epub 2025 Mar 31.
Yamada 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.
Flumignan 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.
Weitz 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.
Other Identifiers
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2013-000619-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16416
Identifier Type: -
Identifier Source: org_study_id