Trial Condition(s):

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

Reduced-dosed rivaroxaban in the long-term prevention of recurrent symptomatic VTE(Venous thromboembolism) (EinsteinChoice)

Bayer Identifier:

16416

ClinicalTrials.gov Identifier:

NCT02064439

EudraCT Number:

2013-000619-26

EU CT Number:

Not Available

Study Completed

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

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

Trial Summary

Enrollment Goal
3365
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Locations
Locations

Investigative Site

Svendborg, Denmark, 5700

Locations

Investigative Site

Hellerup, Denmark, 2900

Locations

Investigative Site

Christchurch, New Zealand, 8011

Locations

Investigative Site

Columbus, United States, 31904

Locations

Investigative Site

Butte, United States, 59701

Locations

Investigative Site

Rockport, United States, 04856

Locations

Investigative Site

SAINT ETIENNE, France, 42055

Locations

Investigative Site

VERNON, France, 27200

Locations

Investigative Site

ARRAS, France, 62000

Locations

Investigative Site

DIJON, France, 21000

Locations

Investigative Site

NICE, France, 06002

Locations

Investigative Site

LIMOGES CEDEX, France, 87042

Locations

Investigative Site

COLOMBES CEDEX, France, 92701

Locations

Investigative Site

GRENOBLE, France, 38043

Locations

Investigative Site

St. Jerome, Canada, J7Z 5T3

Locations

Investigative Site

Montreal, Canada, H3T 1M5

Locations

Investigative Site

AALST, Belgium, 9300

Locations

Investigative Site

HASSELT, Belgium, 3500

Locations

Investigative Site

Leuven, Belgium, 3000

Locations

Investigative Site

AMSTERDAM, Netherlands, 1105 AZ

Locations

Investigative Site

ZWOLLE, Netherlands, 8025 AB

Locations

Investigative Site

HOOFDDORP, Netherlands, 2134 TM

Locations

Investigative Site

SITTARD, Netherlands, 6131 BK

Locations

Investigative Site

Göteborg, Sweden, 416 85

Locations

Investigative Site

Kristianstad, Sweden, 29185

Locations

Investigative Site

Herning, Denmark, 7400

Locations

Investigative Site

København NV, Denmark, 2400

Locations

Investigative Site

Aarhus N, Denmark, 8200

Locations

Investigative Site

Palmerston North, New Zealand, 4414

Locations

Investigative Site

Padova, Italy, 35128

Locations

Investigative Site

Madrid, Spain, 28007

Locations

Investigative Site

Reggio Emilia, Italy, 42100

Locations

Investigative Site

Varese, Italy, 21100

Locations

Investigative Site

ALKMAAR, Netherlands, 1815 JD

Locations

Investigative Site

Holon, Israel, 5810001

Locations

Investigative Site

RANDWICK, Australia, 2031

Locations

Investigative Site

Redcliffe, Australia, 4020

Locations

Investigative Site

Box Hill, Australia, 3128

Locations

Investigative Site

Brisbane, Australia, 4029

Locations

Investigative Site

Debrecen, Hungary, 4032

Locations

Investigative Site

Genève, Switzerland, 1205

Locations

Investigative Site

Taipei, Taiwan, China, 11217

Locations

Investigative Site

Bangkok, Thailand, 10400

Locations

Investigative Site

Mainz, Germany, 55131

Locations

Investigative Site

Dresden, Germany, 01067

Locations

Investigative Site

Berlin, Germany, 10787

Locations

Investigative Site

BESANCON, France, 25030

Locations

Investigative Site

STRASBOURG CEDEX, France, 67091

Locations

Investigative Site

Girona, Spain, 17007

Locations

Investigative Site

London, Canada, N6A 4G5

Locations

Investigative Site

Groningen, Netherlands, 9713 GZ

Locations

Investigative Site

Fredrikstad, Norway, 1603

Locations

Investigative Site

Tel-Aviv, Israel, 64239

Locations

Investigative Site

Wien, Austria, 1090

Locations

Investigative Site

Graz, Austria, 8036

Locations

Investigative Site

Budapest, Hungary, 1115

Locations

Investigative Site

Kecskemet, Hungary, 6000

Locations

Investigative Site

Lausanne, Switzerland, 1011

Locations

Investigative Site

Taichung, Taiwan, China, 40447

Locations

Investigative Site

Magdeburg, Germany, 39112

Locations

Investigative Site

PARIS CEDEX 15, France, 75908

Locations

Investigative Site

PARIS, France, 75475

Locations

Investigative Site

TOULOUSE, France, 31403

Locations

Investigative Site

Warszawa, Poland, 01-138

Locations

Investigative Site

Victoria, Canada, V8R 4R2

Locations

Investigative Site

Montreal, Canada, H3T 1E2

Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1200

Locations

Investigative Site

Copenhagen, Denmark, 2300

Locations

Investigative Site

Oslo, Norway, 0450

Locations

Investigative Site

Pretoria, South Africa, 0181

Locations

Investigative Site

Litomysl, Czech Republic, 570 14

Locations

Investigative Site

Kladno, Czech Republic, 27259

Locations

Investigative Site

Praha 1, Czech Republic, 110 00

Locations

Investigative Site

Praha 5, Czech Republic, 150 06

Locations

Investigative Site

Liberec, Czech Republic, 46063

Locations

Investigative Site

Garran, Australia, 2605

Locations

Investigative Site

Melbourne, Australia, 3004

Locations

Investigative Site

St Leonards, Australia, 2065

Locations

Investigative Site

LISMORE, Australia, 2480

Locations

Investigative Site

Innsbruck, Austria, 6020

Locations

Investigative Site

São Paulo, Brazil, 01323-001

Locations

Investigative Site

São Paulo, Brazil, 04039-004

Locations

Investigative Site

Porto Alegre, Brazil

Locations

Investigative Site

Campinas, Brazil, 13083-970

Locations

Investigative Site

Luzern, Switzerland, 6000

Locations

Investigative Site

Auckland, New Zealand, 1023

Locations

Investigative Site

Cosenza, Italy, 87100

Locations

Investigative Site

Newcastle Upon Tyne, United Kingdom, NE1 4LP

Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1070

Locations

Investigative Site

Ostrava, Czech Republic, 728 80

Locations

Investigative Site

Santo André, Brazil, 09060-650

Locations

Investigative Site

Sao Paulo, Brazil, 05403-900

Locations

Investigative Site

Nanning, China, 530021

Locations

Investigative Site

Yinchuan, China, 750004

Locations

Investigative Site

Wellington, New Zealand, 6021

Locations

Investigative Site

Nahariya, Israel, 2210001

Locations

Investigative Site

Petah Tikva, Israel, 4941492

Locations

Investigative Site

Haifa, Israel, 3339419

Locations

Investigative Site

Zefat, Israel, 1311001

Locations

Investigative Site

London, United Kingdom, SE1 7EH

Locations

Investigative Site

CASTELNAU LE LEZ, France, 34170

Locations

Investigative Site

Afula, Israel, 1834111

Locations

Investigative Site

Kfar Saba, Israel, 4428164

Locations

Investigative Site

Quezon City, Philippines, NCR 1100

Locations

Investigative Site

Witten, Germany, 58448

Locations

Investigative Site

Dresden, Germany, 01307

Locations

Investigative Site

Karlsbad, Germany, 76307

Locations

Investigative Site

TOULON, France, 83056

Locations

Investigative Site

ANGERS, France, 49933

Locations

Investigative Site

Poznan, Poland, 60-631

Locations

Investigative Site

Bydgoszcz, Poland, 85-681

Locations

Investigative Site

Wroclaw, Poland, 51-124

Locations

Investigative Site

Chieti, Italy, 66013

Locations

Investigative Site

Torrevieja, Spain, 03186

Locations

Investigative Site

L'Hospitalet de Llobregat, Spain, 08907

Locations

Investigative Site

San Sebastián de los Reyes, Spain, 28702

Locations

Investigative Site

Johannesburg, South Africa, 2191

Locations

Investigative Site

Pretoria West, South Africa, 0082

Locations

Investigative Site

Prague, Czech Republic, 118 33

Locations

Investigative Site

Ostrava, Czech Republic, 708 52

Locations

Investigative Site

Haifa, Israel, 3109601

Locations

Investigative Site

Seoul, South Korea, 120-752

Locations

Investigative Site

Genève, Switzerland, 1205

Locations

Investigative Site

Perugia, Italy, 06156

Locations

Investigative Site

Treviso, Italy, 31029

Locations

Investigative Site

MAASTRICHT, Netherlands, 6229 HX

Locations

Investigative Site

Istanbul, Turkey, 34-300

Locations

Investigative Site

Rio de Janeiro, Brazil

Locations

Investigative Site

Belo Horizonte, Brazil, 30150-221

Locations

Investigative Site

Hull, United Kingdom, HU3 2JZ

Locations

Investigative Site

Bloemfontein, South Africa, 9301

Locations

Investigative Site

Roodepoort, South Africa, 1724

Locations

Investigative Site

Raleigh, United States, 27607

Locations

Investigative Site

Jacksonville, United States, 32207

Locations

Investigative Site

Spokane, United States, 99216

Locations

Investigative Site

Bern, Switzerland, 3010

Locations

Investigative Site

Plymouth, United Kingdom, PL6 8DH

Locations

Investigative Site

Philadelphia, United States, 19104

Locations

Investigative Site

Detroit, United States, 48202

Locations

Investigative Site

Ottawa, Canada, K1H 8L6

Locations

Investigative Site

Montreal, Canada, H1T 2M4

Locations

Investigative Site

León, Mexico, 37000

Locations

Investigative Site

Monterrey, Mexico, 64718

Locations

Investigative Site

Guadalajara, Mexico, 44340

Locations

Investigative Site

Xalapa, Mexico, 91020

Locations

Investigative Site

Guadalajara, Mexico, 44280

Locations

Investigative Site

Glostrup, Denmark, 2600

Locations

Investigative Site

Beijing, China, 100029

Locations

Investigative Site

Auckland, New Zealand, 2024

Locations

Investigative Site

New Taipei City, Taiwan, China, 220

Locations

Investigative Site

München, Germany, 80336

Locations

Investigative Site

Erfurt, Germany, 99089

Locations

Investigative Site

Darmstadt, Germany, 64297

Locations

Investigative Site

Halifax, Canada, B3H 3A7

Locations

Investigative Site

Edmonton, Canada, T6G 2B7

Locations

Investigative Site

Aguascalientes, Mexico, 20230

Locations

Investigative Site

Merida, Mexico, 97129

Locations

Investigative Site

Johannesburg, South Africa, 2132

Locations

Investigative Site

Santo André, Brazil, 09190-615

Locations

Investigative Site

Shijiazhuang, China, 050000

Locations

Investigative Site

Khon Kaen, Thailand, 40002

Locations

Investigative Site

LE MANS, France, 72037

Locations

Investigative Site

ASSEN, Netherlands, 9401 RK

Locations

Investigative Site

St. Petersburg, Russia

Locations

Investigative Site

Rostov-on-Don, Russia, 344022

Locations

Investigative Site

Tver, Russia, 170036

Locations

Investigative Site

Moscow, Russia, 121552

Locations

Investigative Site

St. Petersburg, Russia, 197022

Locations

Investigative Site

Ryazan, Russia, 390026

Locations

Investigative Site

Barnaul, Russia, 656045

Locations

Investigative Site

Moscow, Russia, 111539

Locations

Investigative Site

Novosibirsk, Russia, 630087

Locations

Investigative Site

Novosibirsk, Russia, 630055

Locations

Investigative Site

CLERMONT FERRAND, France, 63000

Locations

Investigative Site

BREST CEDEX, France, 29609

Locations

Investigative Site

Saint John, Canada, E2L 4L2

Locations

Investigative Site

Ho Chi Minh, Vietnam, 70000

Locations

Investigative Site

Worcester, South Africa, 6850

Locations

Investigative Site

Usti nad Labem, Czech Republic, 401 13

Locations

Investigative Site

Chihuahua, Mexico, 31203

Locations

Investigative Site

PARIS, France, 75674

Locations

Investigative Site

Guangzhou, China, 510120

Locations

Investigative Site

Qingdao, China, 266000

Locations

Investigative Site

Clayton, Australia, 3168

Locations

Investigative Site

Concord, Australia, 2139

Locations

Investigative Site

Kogarah, Australia, 2217

Locations

Investigative Site

Tacoma, United States, 98405-2433

Locations

Investigative Site

Fredericksburg, United States, 22401

Locations

Investigative Site

La Jolla, United States, 92037

Locations

Investigative Site

Seattle, United States, 98104

Locations

Investigative Site

Las Vegas, United States, 89169

Locations

Investigative Site

Sochi, Russia, 354057

Locations

Investigative Site

Basel, Switzerland, 4031

Locations

Investigative Site

Fribourg, Switzerland, 1700

Locations

Investigative Site

DORDRECHT, Netherlands, 3318 AT

Locations

Investigative Site

Donggu,, South Korea, 501-757

Locations

Investigative Site

Seoul, South Korea, 03080

Locations

Investigative Site

Seoul, South Korea, 135-710

Locations

Investigative Site

Busan, South Korea, 602-739

Locations

Investigative Site

Daegu, South Korea, 705-718

Locations

Investigative Site

shanghai, China, 200433

Locations

Investigative Site

guangzhou, China, 510080

Locations

Investigative Site

Hangzhou, China, 310016

Locations

Investigative Site

Kunming, China, 650032

Locations

Investigative Site

Taiyuan, China, 030001

Locations

Investigative Site

shanghai, China, 200001

Locations

Investigative Site

Beijing, China, 100730

Locations

Investigative Site

Beijing, China, 100037

Locations

Investigative Site

Changsha, China, 410011

Locations

Investigative Site

Beijing, China, 100730

Locations

Investigative Site

Shanghai, China, 200032

Locations

Investigative Site

Beijing, China, 100053

Locations

Investigative Site

Jinan, China, 250012

Locations

Investigative Site

Chengdu, China, 610041

Locations

Investigative Site

Shenyang, China, 110001

Locations

Investigative Site

Xi'an, China, 710061

Locations

Investigative Site

Hangzhou, China, 310003

Locations

Investigative Site

Harbin, China

Locations

Investigative Site

Beijing, China, 100020

Locations

Investigative Site

Xi'an, China, 710032

Locations

Investigative Site

Nantong, China, 226001

Locations

Investigative Site

Wuhan, China, 430032

Locations

Investigative Site

Shanghai, China, 200025

Locations

Investigative Site

Shengyang, China, 110004

Locations

Investigative Site

Tianjin, China, 300052

Locations

Investigative Site

Shanghai, China, 200233

Locations

Investigative Site

Changchun, China, 130000

Locations

Investigative Site

Tianjin, China, 300211

Locations

Investigative Site

Tianjin, China, 300121

Locations

Investigative Site

Ha Noi, Vietnam

Locations

Investigative Site

Suzhou, China, 215004

Locations

Investigative Site

Changsha, China, 410013

Locations

Investigative Site

Shanghai, China, 200433

Locations

Investigative Site

Fuzhou, China, 350025

Locations

Investigative Site

LE KREMLIN BICETRE CEDEX, France, 94275

Locations

Investigative Site

San Antonio, United States, 78229

Locations

Investigative Site

Hamilton, Canada, L8N 4A6

Locations

Investigative Site

ALMERE, Netherlands, 1315 RA

Locations

Investigative Site

BOIS-GUILLAUME, France, 76320

Locations

Investigative Site

QUIMPER, France, 29000

Locations

Investigative Site

BREST Cedex 9, France, 29240

Locations

Investigative Site

Hamilton, Canada, L8L 2X2

Locations

Investigative Site

Hamilton, Canada, L8V 1C3

Locations

Investigative Site

Istanbul, Turkey, 34760

Locations

Investigative Site

Bialystok, Poland, 15-276

Locations

Investigative Site

Leon, Mexico, 37000

Locations

Investigative Site

Wenzhou, China, 325000

Locations

Investigative Site

Heidelberg, Germany, 69120

Locations

Investigative Site

Gyula, Hungary, 5700

Locations

Investigative Site

Miskolc, Hungary, 3526

Locations

Investigative Site

Baja, Hungary, 6500

Locations

Investigative Site

Szombathely, Hungary, 9700

Locations

Investigative Site

Pecs, Hungary, 7624

Locations

Investigative Site

Szentes, Hungary, 6600

Locations

Investigative Site

Zalaegerszeg, Hungary, 8900

Locations

Investigative Site

Westmead, Australia, 2145

Locations

Investigative Site

Boston, United States, 02215

Locations

Investigative Site

Ventura, United States, 93003

Locations

Investigative Site

Denver, United States, 80262

Locations

Investigative Site

Treviso, Italy, 31033

Locations

Investigative Site

Columbus, United States, 43210-1240

Locations

Investigative Site

Joliet, United States, 60435

Locations

Investigative Site

Beverly Hills, United States, 90211

Locations

Investigative Site

Toledo, United States, 43606

Locations

Investigative Site

Boston, United States, 02115

Locations

Investigative Site

Bellevue, United States, 98004

Locations

Investigative Site

Piacenza, Italy, 29121

Locations

Investigative Site

Cardiff, United Kingdom, CF14 4XW

Locations

Investigative Site

Auckland, New Zealand, 1309

Locations

Investigative Site

Boston, United States, 02114-2696

Trial Design