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Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic VTE(Venous Thromboembolism) (EinsteinChoice)

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ClinicalTrials.gov Identifier: NCT02064439
Recruitment Status : Completed
First Posted : February 17, 2014
Results First Posted : December 19, 2017
Last Update Posted : December 19, 2017
Sponsor:
Collaborator:
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Bayer

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


Condition or disease Intervention/treatment Phase
Pulmonary Embolism Thromboembolism Thrombosis Venous Thrombosis Venous Thromboembolism Drug: BAY 59-7939 Drug: ASA Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3365 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : March 5, 2014
Actual Primary Completion Date : September 22, 2016
Actual Study Completion Date : November 4, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1
Rivaroxaban 10 mg once daily for 12 months
Drug: BAY 59-7939
10 mg tablet once daily for 12 months
Experimental: Arm 2
Rivaroxaban 20 mg once daily for 12 months
Drug: BAY 59-7939
20 mg tablet once daily for 12 months
Active Comparator: Arm 3
ASA (Acetylsalicylic Acid) 100 mg once daily for 12 months
Drug: ASA
100 mg tablet once daily for 12 months



Primary Outcome Measures :
  1. Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism [ Time Frame: Up to 12 months, at least 6 months ]

    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.


  2. Number of Participants With First Treatment-emergent Major Bleeding [ Time Frame: Up to 12 months, at least 6 months ]

    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.



Secondary Outcome Measures :
  1. Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism [ Time Frame: Up to 12 months, at least 6 months ]
    The secondary efficacy outcome is the composite of the primary efficacy outcome, myocardial infarction (MI), ischemic stroke or non-central nervous system (CNS) systemic embolism. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.

  2. Number of Participants With Non-major Bleeding Associated With Study Drug Interruption for > 14 Days [ Time Frame: Up to 12 months, at least 6 months ]
    The secondary safety outcome was clinically relevant non-major (CRNM) bleeding, which was adjudicated by the CIAC using the ASA criteria: the bleeding was non-major and the bleeding was associated with a study medication interruption of more than 14 days.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02064439


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Locations
United States, California
Beverly Hills, California, United States, 90211
La Jolla, California, United States, 92037
Ventura, California, United States, 93003
United States, Colorado
Denver, Colorado, United States, 80262
United States, Florida
Jacksonville, Florida, United States, 32207
United States, Georgia
Columbus, Georgia, United States, 31904
United States, Illinois
Joliet, Illinois, United States, 60435
United States, Maine
Rockport, Maine, United States, 04856
United States, Massachusetts
Boston, Massachusetts, United States, 02114-2696
Boston, Massachusetts, United States, 02115
Boston, Massachusetts, United States, 02215
United States, Michigan
Detroit, Michigan, United States, 48202
United States, Montana
Butte, Montana, United States, 59701
United States, Nevada
Las Vegas, Nevada, United States, 89169
United States, North Carolina
Raleigh, North Carolina, United States, 27607
United States, Ohio
Columbus, Ohio, United States, 43210-1240
Toledo, Ohio, United States, 43606
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
San Antonio, Texas, United States, 78229
United States, Virginia
Fredericksburg, Virginia, United States, 22401
United States, Washington
Bellevue, Washington, United States, 98004
Seattle, Washington, United States, 98104
Spokane, Washington, United States, 99216
Tacoma, Washington, United States, 98405-2433
Australia, Australian Capital Territory
Garran, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Concord, New South Wales, Australia, 2139
Kogarah, New South Wales, Australia, 2217
Lismore, New South Wales, Australia, 2480
Randwick, New South Wales, Australia, 2031
St Leonards, New South Wales, Australia, 2065
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Brisbane, Queensland, Australia, 4029
Australia, Victoria
Clayton, Victoria, Australia, 3168
Australia
Box Hill, Australia, 3128
Melbourne, Australia, 3004
Redcliffe, Australia, 4020
Austria
Graz, Steiermark, Austria, 8036
Innsbruck, Tirol, Austria, 6020
Wien, Austria, 1090
Belgium
Aalst, Belgium, 9300
Bruxelles - Brussel, Belgium, 1070
Bruxelles - Brussel, Belgium, 1200
Hasselt, Belgium, 3500
Leuven, Belgium, 3000
Brazil
Belo Horizonte, Minas Gerais, Brazil, 30150-221
Porto Alegre, Rio Grande Do Sul, Brazil
Campinas, Sao Paulo, Brazil, 13083-970
Santo André, Sao Paulo, Brazil, 09060-650
Santo André, Sao Paulo, Brazil, 09190-615
São Paulo, Sao Paulo, Brazil, 01323-001
São Paulo, Sao Paulo, Brazil, 04039-004
Rio de Janeiro, Brazil
Sao Paulo, Brazil, 05403-900
Canada, Alberta
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Victoria, British Columbia, Canada, V8R 4R2
Canada, New Brunswick
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Hamilton, Ontario, Canada, L8L 2X2
Hamilton, Ontario, Canada, L8N 4A6
Hamilton, Ontario, Canada, L8V 1C3
London, Ontario, Canada, N6A 4G5
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Montreal, Quebec, Canada, H1T 2M4
Montreal, Quebec, Canada, H3T 1E2
Montreal, Quebec, Canada, H3T 1M5
St. Jerome, Quebec, Canada, J7Z 5T3
China, Fujian
Fuzhou, Fujian, China, 350025
China, Guangdong
Guangzhou, Guangdong, China, 510080
Guangzhou, Guangdong, China, 510120
China, Guangxi
Nanning, Guangxi, China, 530021
China, Hebei
Shijiazhuang, Hebei, China, 050000
China, Heilongjiang
Harbin, Heilongjiang, China
China, Hubei
Wuhan, Hubei, China, 430032
China, Hunan
Changsha, Hunan, China, 410011
Changsha, Hunan, China, 410013
China, Jiangsu
Nantong, Jiangsu, China, 226001
Suzhou, Jiangsu, China, 215004
China, Jilin
Changchun, Jilin, China, 130000
China, Liaoning
Shengyang, Liaoning, China, 110004
Shenyang, Liaoning, China, 110001
China, Ningxia
Yinchuan, Ningxia, China, 750004
China, Shaanxi
Xi'an, Shaanxi, China, 710032
Xi'an, Shaanxi, China, 710061
China, Shandong
Jinan, Shandong, China, 250012
Qingdao, Shandong, China, 266000
China, Shanxi
Taiyuan, Shanxi, China, 030001
China, Sichuan
Chengdu, Sichuan, China, 610041
China, Yunnan
Kunming, Yunnan, China, 650032
China, Zhejiang
Hangzhou, Zhejiang, China, 310003
Hangzhou, Zhejiang, China, 310016
Wenzhou, Zhejiang, China, 325000
China
Beijing, China, 100020
Beijing, China, 100029
Beijing, China, 100037
Beijing, China, 100053
Beijing, China, 100730
Shanghai, China, 200001
Shanghai, China, 200025
Shanghai, China, 200032
Shanghai, China, 200233
Shanghai, China, 200433
Tianjin, China, 300052
Tianjin, China, 300121
Tianjin, China, 300211
Czechia
Kladno, Czechia, 27259
Liberec, Czechia, 46063
Litomysl, Czechia, 570 14
Ostrava, Czechia, 708 52
Ostrava, Czechia, 728 80
Prague, Czechia, 118 33
Praha 1, Czechia, 110 00
Praha 5, Czechia, 150 06
Usti nad Labem, Czechia, 401 13
Denmark
Aarhus N, Denmark, 8200
Copenhagen, Denmark, 2300
Glostrup, Denmark, 2600
Hellerup, Denmark, 2900
Herning, Denmark, 7400
København NV, Denmark, 2400
Svendborg, Denmark, 5700
France
Angers, France, 49933
Arras, France, 62000
Besancon, France, 25030
Bois-guillaume, France, 76320
BREST Cedex 9, France, 29240
Brest Cedex, France, 29609
Castelnau Le Lez, France, 34170
Clermont Ferrand, France, 63000
Colombes Cedex, France, 92701
Dijon, France, 21000
Grenoble, France, 38043
Le Kremlin Bicetre Cedex, France, 94275
Le Mans, France, 72037
Limoges Cedex, France, 87042
Nice, France, 06002
Paris Cedex 15, France, 75908
Paris, France, 75475
Paris, France, 75674
Quimper, France, 29000
Saint Etienne, France, 42055
Strasbourg Cedex, France, 67091
Toulon, France, 83056
Toulouse, France, 31403
Vernon, France, 27200
Germany
Heidelberg, Baden-Württemberg, Germany, 69120
München, Bayern, Germany, 80336
Darmstadt, Hessen, Germany, 64297
Witten, Nordrhein-Westfalen, Germany, 58448
Mainz, Rheinland-Pfalz, Germany, 55131
Magdeburg, Sachsen-Anhalt, Germany, 39112
Dresden, Sachsen, Germany, 01067
Dresden, Sachsen, Germany, 01307
Erfurt, Thüringen, Germany, 99089
Berlin, Germany, 10787
Karlsbad, Germany, 76307
Hungary
Baja, Hungary, 6500
Budapest, Hungary, 1115
Debrecen, Hungary, 4032
Gyula, Hungary, 5700
Kecskemet, Hungary, 6000
Miskolc, Hungary, 3526
Pecs, Hungary, 7624
Szentes, Hungary, 6600
Szombathely, Hungary, 9700
Zalaegerszeg, Hungary, 8900
Israel
Afula, Israel, 1834111
Haifa, Israel, 3109601
Haifa, Israel, 3339419
Holon, Israel, 5810001
Kfar Saba, Israel, 4428164
Nahariya, Israel, 2210001
Petah Tikva, Israel, 4941492
Tel-Aviv, Israel, 64239
Zefat, Israel, 1311001
Italy
Chieti, Abruzzo, Italy, 66013
Cosenza, Calabria, Italy, 87100
Piacenza, Emilia-Romagna, Italy, 29121
Reggio Emilia, Emilia-Romagna, Italy, 42100
Varese, Lombardia, Italy, 21100
Perugia, Umbria, Italy, 06156
Padova, Veneto, Italy, 35128
Treviso, Veneto, Italy, 31029
Treviso, Veneto, Italy, 31033
Korea, Republic of
Donggu,, Gwangju Gwang''yeogsi, Korea, Republic of, 501-757
Busan, Korea, Republic of, 602-739
Daegu, Korea, Republic of, 705-718
Seoul, Korea, Republic of, 03080
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 135-710
Mexico
Leon, Guanajuato, Mexico, 37000
León, Guanajuato, Mexico, 37000
Guadalajara, Jalisco, Mexico, 44280
Guadalajara, Jalisco, Mexico, 44340
Monterrey, Nuevo Leon, Mexico, 64718
Xalapa, Veracruz, Mexico, 91020
Merida, Yucatán, Mexico, 97129
Aguascalientes, Mexico, 20230
Chihuahua, Mexico, 31203
Netherlands
Alkmaar, Netherlands, 1815 JD
Almere, Netherlands, 1315 RA
Amsterdam, Netherlands, 1105 AZ
Assen, Netherlands, 9401 RK
Dordrecht, Netherlands, 3318 AT
Groningen, Netherlands, 9713 GZ
Hoofddorp, Netherlands, 2134 TM
Maastricht, Netherlands, 6229 HX
Sittard, Netherlands, 6131 BK
Zwolle, Netherlands, 8025 AB
New Zealand
Auckland, New Zealand, 1023
Auckland, New Zealand, 1309
Auckland, New Zealand, 2024
Christchurch, New Zealand, 8011
Palmerston North, New Zealand, 4414
Wellington, New Zealand, 6021
Norway
Fredrikstad, Norway, 1603
Oslo, Norway, 0450
Philippines
Quezon City, Philippines, NCR 1100
Poland
Bialystok, Poland, 15-276
Bydgoszcz, Poland, 85-681
Poznan, Poland, 60-631
Warszawa, Poland, 01-138
Wroclaw, Poland, 51-124
Russian Federation
Barnaul, Russian Federation, 656045
Moscow, Russian Federation, 111539
Moscow, Russian Federation, 121552
Novosibirsk, Russian Federation, 630055
Novosibirsk, Russian Federation, 630087
Rostov-on-Don, Russian Federation, 344022
Ryazan, Russian Federation, 390026
Sochi, Russian Federation, 354057
St. Petersburg, Russian Federation, 197022
St. Petersburg, Russian Federation
Tver, Russian Federation, 170036
South Africa
Johannesburg, Gauteng, South Africa, 2132
Johannesburg, Gauteng, South Africa, 2191
Pretoria West, Gauteng, South Africa, 0082
Pretoria, Gauteng, South Africa, 0181
Roodepoort, Gauteng, South Africa, 1724
Worcester, Western Cape, South Africa, 6850
Bloemfontein, South Africa, 9301
Spain
Torrevieja, Alicante, Spain, 03186
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
San Sebastián de los Reyes, Madrid, Spain, 28702
Girona, Spain, 17007
Madrid, Spain, 28007
Sweden
Göteborg, Sweden, 416 85
Kristianstad, Sweden, 29185
Switzerland
Basel, Basel-Stadt, Switzerland, 4031
Lausanne, Vaud, Switzerland, 1011
Bern, Switzerland, 3010
Fribourg, Switzerland, 1700
Genève, Switzerland, 1205
Luzern, Switzerland, 6000
Taiwan
New Taipei City, Taiwan, 220
Taichung, Taiwan, 40447
Taipei, Taiwan, 11217
Thailand
Bangkok, Thailand, 10400
Khon Kaen, Thailand, 40002
Turkey
Istanbul, Turkey, 34-300
Istanbul, Turkey, 34760
United Kingdom
Plymouth, Devon, United Kingdom, PL6 8DH
Hull, Humberside, United Kingdom, HU3 2JZ
Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE1 4LP
Cardiff, United Kingdom, CF14 4XW
London, United Kingdom, SE1 7EH
Vietnam
Ha Noi, Vietnam
Ho Chi Minh, Vietnam, 70000
Sponsors and Collaborators
Bayer
Janssen Scientific Affairs, LLC
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02064439     History of Changes
Other Study ID Numbers: 16416
2013-000619-26 ( EudraCT Number )
First Posted: February 17, 2014    Key Record Dates
Results First Posted: December 19, 2017
Last Update Posted: December 19, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
deep vein thrombosis
pulmonary embolism
long-term prevention of recurrent symptomatic VTE

Additional relevant MeSH terms:
Thrombosis
Thromboembolism
Embolism
Venous Thromboembolism
Pulmonary Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants