check_circleStudy Completed

Pulmonary Embolism, Thromboembolism, Thrombosis, Venous Thrombosis, Venous Thromboembolism

Bayer Identifier:

16416

ClinicalTrials.gov Identifier:

NCT02064439

EudraCT Number:

2013-000619-26

EU CT Number:

Not Available
Reduced-dosed rivaroxaban in the long-term prevention of recurrent symptomatic VTE(Venous thromboembolism)

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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

  • - 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

Trial summary

Enrollment Goal
3365
Trial Dates
March 2014 - November 2016
Phase
Phase 3
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Svendborg, 5700, Denmark
Completed
Hellerup, 2900, Denmark
Completed
Christchurch, 8011, New Zealand
Completed
Columbus, 31904, United States
Completed
Butte, 59701, United States
Completed
Rockport, 04856, United States
Completed
SAINT ETIENNE, 42055, France
Completed
VERNON, 27200, France
Completed
ARRAS, 62000, France
Completed
DIJON, 21000, France
Completed
NICE, 06002, France
Completed
LIMOGES CEDEX, 87042, France
Completed
COLOMBES CEDEX, 92701, France
Completed
GRENOBLE, 38043, France
Completed
St. Jerome, J7Z 5T3, Canada
Completed
Montreal, H3T 1M5, Canada
Completed
AALST, 9300, Belgium
Completed
HASSELT, 3500, Belgium
Completed
Leuven, 3000, Belgium
Completed
AMSTERDAM, 1105 AZ, Netherlands
Completed
ZWOLLE, 8025 AB, Netherlands
Completed
HOOFDDORP, 2134 TM, Netherlands
Completed
SITTARD, 6131 BK, Netherlands
Completed
Göteborg, 416 85, Sweden
Completed
Kristianstad, 29185, Sweden
Completed
Herning, 7400, Denmark
Completed
København NV, 2400, Denmark
Completed
Aarhus N, 8200, Denmark
Completed
Palmerston North, 4414, New Zealand
Completed
Padova, 35128, Italy
Completed
Madrid, 28007, Spain
Completed
Reggio Emilia, 42100, Italy
Completed
Varese, 21100, Italy
Completed
ALKMAAR, 1815 JD, Netherlands
Completed
Holon, 5810001, Israel
Completed
RANDWICK, 2031, Australia
Completed
Redcliffe, 4020, Australia
Completed
Box Hill, 3128, Australia
Terminated
Brisbane, 4029, Australia
Completed
Debrecen, 4032, Hungary
Completed
Genève, 1205, Switzerland
Completed
Taipei, 11217, Taiwan
Completed
Bangkok, 10400, Thailand
Completed
Mainz, 55131, Germany
Completed
Dresden, 01067, Germany
Completed
Berlin, 10787, Germany
Completed
BESANCON, 25030, France
Completed
STRASBOURG CEDEX, 67091, France
Completed
Girona, 17007, Spain
Completed
London, N6A 4G5, Canada
Completed
Groningen, 9713 GZ, Netherlands
Completed
Fredrikstad, 1603, Norway
Terminated
Tel-Aviv, 64239, Israel
Completed
Wien, 1090, Austria
Completed
Graz, 8036, Austria
Completed
Budapest, 1115, Hungary
Completed
Kecskemet, 6000, Hungary
Completed
Lausanne, 1011, Switzerland
Completed
Taichung, 40447, Taiwan
Terminated
Magdeburg, 39112, Germany
Completed
PARIS CEDEX 15, 75908, France
Completed
PARIS CEDEX 15, 75908, France
Completed
PARIS, 75475, France
Completed
TOULOUSE, 31403, France
Completed
Warszawa, 01-138, Poland
Completed
Victoria, V8R 4R2, Canada
Completed
Montreal, H3T 1E2, Canada
Completed
BRUXELLES - BRUSSEL, 1200, Belgium
Completed
Copenhagen, 2300, Denmark
Completed
Oslo, 0450, Norway
Completed
Pretoria, 0181, South Africa
Completed
Litomysl, 570 14, Czech Republic
Completed
Kladno, 27259, Czech Republic
Completed
Praha 1, 110 00, Czech Republic
Completed
Praha 5, 150 06, Czech Republic
Completed
Liberec, 46063, Czech Republic
Terminated
Garran, 2605, Australia
Completed
Melbourne, 3004, Australia
Completed
St Leonards, 2065, Australia
Completed
LISMORE, 2480, Australia
Completed
Innsbruck, 6020, Austria
Completed
Wien, 1090, Austria
Completed
São Paulo, 01323-001, Brazil
Completed
São Paulo, 04039-004, Brazil
Completed
Porto Alegre, Brazil
Completed
Campinas, 13083-970, Brazil
Completed
Luzern, 6000, Switzerland
Completed
Auckland, 1023, New Zealand
Completed
Cosenza, 87100, Italy
Completed
Newcastle Upon Tyne, NE1 4LP, United Kingdom
Completed
BRUXELLES - BRUSSEL, 1070, Belgium
Completed
Ostrava, 728 80, Czech Republic
Completed
Santo André, 09060-650, Brazil
Completed
Sao Paulo, 05403-900, Brazil
Completed
Nanning, 530021, China
Completed
Yinchuan, 750004, China
Completed
Wellington, 6021, New Zealand
Completed
Nahariya, 2210001, Israel
Completed
Petah Tikva, 4941492, Israel
Completed
Haifa, 3339419, Israel
Completed
Zefat, 1311001, Israel
Terminated
London, SE1 7EH, United Kingdom
Completed
CASTELNAU LE LEZ, 34170, France
Completed
Afula, 1834111, Israel
Completed
Kfar Saba, 4428164, Israel
Completed
Holon, 5810001, Israel
Completed
Quezon City, NCR 1100, Philippines
Completed
Witten, 58448, Germany
Completed
Dresden, 01307, Germany
Completed
Karlsbad, 76307, Germany
Completed
TOULON, 83056, France
Completed
ANGERS, 49933, France
Completed
Poznan, 60-631, Poland
Completed
Bydgoszcz, 85-681, Poland
Completed
Wroclaw, 51-124, Poland
Completed
Chieti, 66013, Italy
Completed
Torrevieja, 03186, Spain
Completed
L'Hospitalet de Llobregat, 08907, Spain
Completed
San Sebastián de los Reyes, 28702, Spain
Completed
Johannesburg, 2191, South Africa
Completed
Pretoria West, 0082, South Africa
Completed
Prague, 118 33, Czech Republic
Completed
Ostrava, 708 52, Czech Republic
Completed
Haifa, 3109601, Israel
Completed
Seoul, 120-752, Korea, Republic Of
Terminated
Genève, 1205, Switzerland
Completed
Perugia, 06156, Italy
Completed
Treviso, 31029, Italy
Completed
MAASTRICHT, 6229 HX, Netherlands
Completed
Petah Tikva, 4941492, Israel
Completed
Istanbul, 34-300, Turkey
Completed
Rio de Janeiro, Brazil
Completed
Belo Horizonte, 30150-221, Brazil
Completed
Hull, HU3 2JZ, United Kingdom
Completed
Bloemfontein, 9301, South Africa
Completed
Roodepoort, 1724, South Africa
Completed
Raleigh, 27607, United States
Terminated
Jacksonville, 32207, United States
Completed
Spokane, 99216, United States
Completed
Bern, 3010, Switzerland
Completed
Plymouth, PL6 8DH, United Kingdom
Terminated
Philadelphia, 19104, United States
Completed
Detroit, 48202, United States
Completed
Ottawa, K1H 8L6, Canada
Completed
Montreal, H1T 2M4, Canada
Terminated
León, 37000, Mexico
Terminated
Monterrey, 64718, Mexico
Completed
Guadalajara, 44340, Mexico
Completed
Xalapa, 91020, Mexico
Terminated
Guadalajara, 44280, Mexico
Completed
Glostrup, 2600, Denmark
Completed
Beijing, 100029, China
Completed
Auckland, 2024, New Zealand
Completed
New Taipei City, 220, Taiwan
Completed
München, 80336, Germany
Completed
Erfurt, 99089, Germany
Completed
Darmstadt, 64297, Germany
Completed
Halifax, B3H 3A7, Canada
Completed
Edmonton, T6G 2B7, Canada
Completed
Aguascalientes, 20230, Mexico
Completed
Merida, 97129, Mexico
Completed
Johannesburg, 2132, South Africa
Completed
Santo André, 09190-615, Brazil
Completed
Shijiazhuang, 050000, China
Completed
Khon Kaen, 40002, Thailand
Completed
LE MANS, 72037, France
Completed
ASSEN, 9401 RK, Netherlands
Completed
St. Petersburg, Russia
Completed
Rostov-on-Don, 344022, Russia
Completed
Tver, 170036, Russia
Completed
Moscow, 121552, Russia
Completed
St. Petersburg, 197022, Russia
Completed
Ryazan, 390026, Russia
Completed
Barnaul, 656045, Russia
Completed
Moscow, 111539, Russia
Completed
Novosibirsk, 630087, Russia
Completed
Novosibirsk, 630055, Russia
Completed
CLERMONT FERRAND, 63000, France
Completed
BREST CEDEX, 29609, France
Completed
Saint John, E2L 4L2, Canada
Completed
Ho Chi Minh, 70000, Viet Nam
Completed
Ho Chi Minh, 70000, Viet Nam
Completed
Worcester, 6850, South Africa
Completed
Usti nad Labem, 401 13, Czech Republic
Terminated
Chihuahua, 31203, Mexico
Terminated
PARIS, 75674, France
Completed
Guangzhou, 510120, China
Terminated
Qingdao, 266000, China
Completed
Clayton, 3168, Australia
Completed
Concord, 2139, Australia
Completed
Kogarah, 2217, Australia
Completed
Tacoma, 98405-2433, United States
Terminated
Fredericksburg, 22401, United States
Completed
La Jolla, 92037, United States
Completed
Seattle, 98104, United States
Completed
Las Vegas, 89169, United States
Completed
Sochi, 354057, Russia
Completed
Basel, 4031, Switzerland
Completed
Fribourg, 1700, Switzerland
Completed
DORDRECHT, 3318 AT, Netherlands
Completed
Donggu,, 501-757, Korea, Republic Of
Completed
Seoul, 03080, Korea, Republic Of
Completed
Seoul, 135-710, Korea, Republic Of
Completed
Busan, 602-739, Korea, Republic Of
Completed
Seoul, 03080, Korea, Republic Of
Completed
Daegu, 705-718, Korea, Republic Of
Completed
shanghai, 200433, China
Completed
guangzhou, 510080, China
Completed
Hangzhou, 310016, China
Completed
Kunming, 650032, China
Completed
Taiyuan, 030001, China
Terminated
shanghai, 200001, China
Terminated
Beijing, 100730, China
Terminated
Beijing, 100037, China
Completed
Changsha, 410011, China
Completed
Beijing, 100730, China
Completed
Shanghai, 200032, China
Terminated
Beijing, 100053, China
Completed
Jinan, 250012, China
Terminated
Chengdu, 610041, China
Terminated
Shenyang, 110001, China
Completed
Xi'an, 710061, China
Completed
Hangzhou, 310003, China
Completed
Harbin, China
Terminated
Beijing, 100020, China
Terminated
Xi'an, 710032, China
Completed
Nantong, 226001, China
Completed
Shanghai, 200032, China
Completed
Wuhan, 430032, China
Completed
Shanghai, 200025, China
Terminated
Shengyang, 110004, China
Completed
Tianjin, 300052, China
Terminated
Shanghai, 200233, China
Completed
Changchun, 130000, China
Completed
Tianjin, 300211, China
Completed
Tianjin, 300121, China
Completed
Ha Noi, Viet Nam
Completed
Suzhou, 215004, China
Completed
Changsha, 410013, China
Completed
Guangzhou, 510080, China
Terminated
Shanghai, 200433, China
Completed
Fuzhou, 350025, China
Completed
Beijing, 100029, China
Completed
LE KREMLIN BICETRE CEDEX, 94275, France
Completed
San Antonio, 78229, United States
Terminated
Hamilton, L8N 4A6, Canada
Completed
ALMERE, 1315 RA, Netherlands
Completed
BOIS-GUILLAUME, 76320, France
Completed
QUIMPER, 29000, France
Completed
BREST Cedex 9, 29240, France
Completed
Hamilton, L8L 2X2, Canada
Completed
Hamilton, L8V 1C3, Canada
Completed
Istanbul, 34760, Turkey
Completed
Bialystok, 15-276, Poland
Terminated
Leon, 37000, Mexico
Completed
Wenzhou, 325000, China
Completed
Heidelberg, 69120, Germany
Completed
Gyula, 5700, Hungary
Completed
Miskolc, 3526, Hungary
Terminated
Baja, 6500, Hungary
Completed
Szombathely, 9700, Hungary
Completed
Pecs, 7624, Hungary
Terminated
Szentes, 6600, Hungary
Terminated
Zalaegerszeg, 8900, Hungary
Terminated
Hamilton, L8N 4A6, Canada
Completed
Westmead, 2145, Australia
Completed
Boston, 02215, United States
Terminated
Chengdu, 610041, China
Terminated
Ventura, 93003, United States
Terminated
Denver, 80262, United States
Completed
Treviso, 31033, Italy
Completed
Columbus, 43210-1240, United States
Completed
Joliet, 60435, United States
Completed
Beverly Hills, 90211, United States
Completed
Toledo, 43606, United States
Terminated
Boston, 02115, United States
Completed
Bellevue, 98004, United States
Completed
Piacenza, 29121, Italy
Completed
Cardiff, CF14 4XW, United Kingdom
Completed
Auckland, 1309, New Zealand
Terminated
Boston, 02114-2696, United States

Primary Outcome

  • Number of participants with the composite of fatal or non-fatal symptomatic recurrent venous thromboembolism
    date_rangeTime Frame:
    Up to 12 months, at least 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with first treatment-emergent major bleeding
    date_rangeTime Frame:
    Up to 12 months, at least 6 months
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Number of participants with the composite of the primary efficacy outcome, myocardial infarction, ischemic stroke or systemic non-CNS embolism
    date_rangeTime Frame:
    Up to 12 months, at least 6 months
  • Number of participants with non-major bleeding associated with study drug interruption for > 14 days
    date_rangeTime Frame:
    Up to 12 months, at least 6 months

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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