Study Completed

Venous Thrombosis

Bayer Identifier:

11702a

ClinicalTrials.gov Identifier:

NCT00440193

EudraCT Number:

2006-004495-13

EU CT Number:

Not Available

Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep vein thrombosis - The EINSTEIN DVT study

Trial purpose

This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic DVT without symptomatic PE (Einstein-DVT).

Key Participants Requirements

Sex

Both

Age

18 Years

Inclusion Criteria

- Confirmed acute symptomatic proximal DVT without symptomatic PE
Exclusion Criteria
- Legal lower age limitations (country specific)
- Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE
- Other indication for VKA than DVT and/or PE
- The pre-randomization anti-coagulant treatment (Criteria # 4) has been prolonged from 36 hours to a maximum of 48 hours.

Trial summary

Enrollment Goal

3449

Trial Dates

March 2007 - April 2010

Phase

Phase 3

Could I Receive a placebo

Products

Xarelto (Rivaroxaban, BAY59-7939)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Klinikum Darmstadt	Darmstadt, 64297, Germany
Completed	Klinikum der Eberhard-Karls-Universität Tübingen	Tübingen, 72076, Germany
Completed	SRH Klinikum-Karlsbad-Langensteinbach gGmbH	Karlsbad, 76307, Germany
Terminated	Klinikum Mannheim gGmbH	Mannheim, 68167, Germany
Completed	Forschungszentrum Ruhr - KliFoCenter GmbH	Witten, 58455, Germany
Completed	Wenckebach-Krankenhaus	Berlin, 12099, Germany
Completed	Universitäts-Krankenhaus Eppendorf	Hamburg, 20251, Germany
Completed	Praxis für Innere Medizin u. Gefäßkrankheiten HBE	Magdeburg, 39112, Germany
Completed	Klinikum der Johann Wolfgang Goethe Universität	Frankfurt, 60590, Germany
Completed	Praxis Hr. Dr. W. Mondorf	Frankfurt, 60596, Germany
Terminated	Universitätskliniken des Saarlandes	Homburg, 66421, Germany
Completed	St. Josefskrankenhaus	Heidelberg, 69115, Germany
Completed	Klinikum Innenstadt der Ludwigs-Maximilians-Universität	München, 81377, Germany
Completed	Brüderkrankenhaus St. Josef	Paderborn, 33098, Germany
Terminated	Zentralklinikum Augsburg	Augsburg, 86156, Germany
Terminated	Klinikum der Justus-Liebig-Universität	Gießen, 35392, Germany
Terminated	Kliniken der Medizinischen Hochschule Hannover	Hannover, 30625, Germany
Completed	Praxis Hr. Dr. P. Baron von Bilderling	München, 80331, Germany
Completed	Klinikum der Universität Würzburg	Würzburg, 97080, Germany
Completed	Diakoniekrankenhaus	Rotenburg, 27342, Germany
Completed	Fürst Stirum Klinik	Bruchsal, 76646, Germany
Completed	Klinikum der Ernst-Moritz-Arndt-Universität	Greifswald, 17475, Germany
Completed	Medizinische Fakultät Carl Gustav Carus	Dresden, 01307, Germany
Terminated	Medizinische Einrichtungen der Heinrich-Heine-Universität	Düsseldorf, 40225, Germany
Completed	Martin-Luther-Universität Halle-Wittenberg	Halle, 06120, Germany
Terminated	Venenzentrum Wiesbaden	Wiesbaden, 65183, Germany
Terminated	Ärztl. Laborgemeinschaft Leipzig, Fr. Dr. Reising-Ackermann	Leipzig, 04289, Germany
Completed	Praxis Hr. Dr. F. Heckmann	Neckargemünd, 69151, Germany
Terminated	Medizinische Einrichtungen der Universität Essen	Essen, 45122, Germany
Terminated	Praxis für Gefäßmedizin Fr. Dr. D. Schulte	Berlin, 10713, Germany
Completed	Klinikum der Eberhard-Karls-Universität Tübingen	Tübingen, 72076, Germany
Completed	Medizinische Fakultät Carl Gustav Carus	Dresden, 01307, Germany
Completed	Klinikum der Johannes-Gutenberg-Universität	Mainz, 55131, Germany
Terminated	Universitätskliniken des Saarlandes	Homburg, 66424, Germany
Terminated	Marienkrankenhaus Soest	Soest, 59494, Germany
Terminated	North Middlesex Hospital	London, United Kingdom
Completed	West Middlesex University Hospital	Isleworth, TW7 6AF, United Kingdom
Terminated	Broomfield Hospital	Chelmsford, CM1 5ET, United Kingdom
Completed	Kings College Hospital	London, SE5 9RS, United Kingdom
Completed	St Thomas' Hospital	London, SE1 7EH, United Kingdom
Completed	Derriford Hospital	Plymouth, PL6 8DH, United Kingdom
Completed	Bay Pines VA Healthcare System	Bay Pines, 33744, United States
Completed	Cancer Care Centers of South Texas	San Antonio, 78229, United States
Completed	Spokane Respiratory Consultants	Spokane, 99204, United States
Completed	University of North Carolina	Chapel Hill, 27599-7035, United States
Completed	University of Utah Medical Center	Salt Lake City, 84132, United States
Completed	Lovelace Health Systems	Albuquerque, 87108-4763, United States
Terminated	Beth Israel Deaconess Medical Center	Boston, 02215, United States
Terminated	Trinity Clinic-Corsicana	Corsicana, 75110, United States
Completed	Oklahoma University Health Science Center	Oklahoma City, 73104, United States
Completed	Pulmonary Associates of Fredericksburg, Inc.	Fredericksburg, 22401, United States
Completed	Eastern Idaho Medical Consultants	Idaho Falls, 83404, United States
Completed	Heritage Cardiology Associates	Camp Hill, 17011, United States
Completed	San Juan VA Medical Center	San Juan, 00927, United States
Completed		Covington, 70433, United States
Completed	JRMD, Inc.	Redlands, 92373, United States
Completed	Wesley Long Community Hospital	Greensboro, 27403, United States
Terminated	Jackson Memorial Hospital	Miami, 33136-1096, United States
Completed	Intermountain Medical Center	Murray, 84157, United States
Completed	Moses H. Cone Memorial Hospital	Greensboro, 27401, United States
Completed	Sinai Hospital of Baltimore	Baltimore, 21215, United States
Completed	The Western Pennsylvania Hospital	Pittsburgh, 15224, United States
Completed	Tacoma General Hospital	Tacoma, 98405, United States
Completed	University of Miami	Miami, 33136, United States
Terminated	Hôpital Trousseau - Tours	TOURS, 37044, France
Completed	Hopital Européen Georges Pompidou - Paris	PARIS CEDEX 15, 75908, France
Terminated	Centre Hospitalier Universitaire - Nimes	NIMES CEDEX 9, 30029, France
Completed	Hopital J. Minjoz - Besançon	BESANCON, 25000, France
Completed	Hopital Européen Georges Pompidou - Paris	PARIS, 75015, France
Terminated	Hôpital Henri Mondor - Créteil	CRETEIL, 94000, France
Completed	Centre Hospitalier Universitaire - Grenoble	GRENOBLE, 38043, France
Completed	Hôpital Civil - Strasbourg	STRASBOURG CEDEX, 67091, France
Terminated	University of Arkansas for Medical Sciences	Little Rock, 72205, United States
Completed	Hôpital Nord-SAINT ETIENNE	SAINT ETIENNE, 42055, France
Completed	Centre hospitalier Intercommunal - Vernon	VERNON, 27200, France
Completed	Centre Hospitalier - Valenciennes Cedex	VALENCIENNES CEDEX, 59322, France
Completed	Hôpital Saint André - Bordeaux	BORDEAUX, 33000, France
Terminated	Hopital Bichat - Paris	PARIS, 75877, France
Completed	Hôpital Pasteur - Nice	NICE, 06002, France
Completed	Hôpital Dupuytren - Limoges Cedex	LIMOGES, 87042, France
Completed	Hôtel Dieu - Paris	PARIS, 75004, France
Completed	Hôpital du Bocage - Dijon	DIJON, 21000, France
Completed	Hôpital Louis Mourier - Colombes Cedex	COLOMBES CEDEX, 92701, France
Completed	Hôpital La Cavale Blanche - Brest Cedex	BREST CEDEX, 29609, France
Completed	Hôpital Antoine Béclère - Clamart	CLAMART, 92141, France
Completed	Hôpital Hôtel Dieu - Nantes Cedex	NANTES, 44000, France
Completed	Hôpital Saint-Eloi - Montpellier Cedex	MONTPELLIER CEDEX, 34295, France
Completed	Centre Hospitalier Universitaire - Angers	ANGERS CEDEX 01, 49033, France
Completed	Centre Hospitalier Lyon Sud - Pierre Bénite	PIERRE BENITE, 69495, France
Completed	Centre Hospitalier - Arras	ARRAS, 62000, France
Completed	Hôpital Font Pré - Toulon	TOULON, 83000, France
Completed	Clinique du Parc	CASTELNAU LE LEZ, 34170, France
Completed	Groupe Hospitalier Sud - Amiens	AMIENS, 80000, France
Terminated	Centre Hospitalier de Roanne	Roanne, 42328, France
Terminated	Centre Hospitalier de la Région d'Annecy	METZ-TESSY, 74370, France
Completed	Szpital Kliniczny	Wroclaw, 50-326, Poland
Terminated	Szpital Uniwersytecki Nr 2 im. J. Bizela	Bydgoszcz, 85-168, Poland
Completed	SP Szpital Kliniczny AM w Bialymstoku	Bialystok, 15-276, Poland
Terminated	Szpital Uniwersytecki CMUJ	Krakow, 31-066, Poland
Terminated	Centralny Szpital Kliniczny AM	Warszawa, 02-097, Poland
Completed	Szpital Kliniczny	Wroclaw, 50-326, Poland
Completed	Wojewodzki Szpital Specjalistyczny	Wroclaw, 51-124, Poland
Terminated	Uniwersyteckie Centrum Kliniczne	Gdansk, 80-952, Poland
Completed	Hôpital Gabriel Montpied - Clermont Ferrand	CLERMONT FERRAND, 63000, France
Completed	Hôpital Lariboisière - Paris	PARIS, 75475, France
Completed	Hopital Général - Agen	AGEN CEDEX 9, 47923, France
Terminated	Centre Hospitalier Universitaire Brabois - Vandoeuvre-les-Na	VANDOEUVRE LES NANCY, 54511, France
Completed	Hôpital de Rangueil - Toulouse	TOULOUSE, 31403, France
Terminated	Hôpital Cardiologique - Lille Cedex	LILLE CEDEX, 59037, France
Terminated	Groupe Hospitalier Mutualiste - Clinique des Eaux Claires	Grenoble, 38028, France
Terminated	Centre Hospitalier d'Orthez	Orthez, 64300, France
Terminated	Hôpital Charles Nicolle - Rouen Cedex	ROUEN CEDEX, 76031, France
Terminated	Centralny Szpital Kliniczny AM	Warszawa, 02-097, Poland
Terminated	Wojewodzki Szpital Specjalistyczny	Wroclaw, 51-124, Poland
Completed	Szpital Uniwersytecki CMUJ	Krakow, 31-066, Poland
Completed	Instytut Gruzlicy i Chorob Pluc	Warszawa, 01-138, Poland
Completed	SPSK nr 1	Lublin, 20-081, Poland
Terminated	SP Szpital Kliniczny nr 7 Slaskiego Uniwersytetu Medycznego	Katowice, 40-365, Poland
Completed	Szpiatal Kliniczny nr 1	Poznan, 61-848, Poland
Terminated	Miedzyleski Szpital Specjalistyczny	Warszawa, 04-479, Poland
Completed	Wojew. Szpital Zespolony	Torun, 87-100, Poland
Completed	AULSS 12 Veneziana	Venezia, 30122, Italy
Completed	A.O. San Paolo Polo Universitario	Milano, 20142, Italy
Terminated	A.O.U. Federico II	Napoli, 80131, Italy
Completed	IRCCS Osp Maggiore Policlinico	Milano, 20122, Italy
Completed	A.O.U. Policlinico S.Orsola-Malpighi	Bologna, 40138, Italy
Terminated	Istituti Ospedalieri di Cremona	Cremona, 26100, Italy
Completed	A.O.U. Policlinico Giaccone	Palermo, 90127, Italy
Terminated	Fundación Hospital Alcorcón	Alcorcón, 28922, Spain
Terminated	Hospital Ramón y Cajal	Madrid, 28034, Spain
Completed	Hospital Virgen del Camino	Pamplona, 31008, Spain
Completed	Szpital im. N. Barlickiego	Lodz, 90-153, Poland
Completed	ZOZ MSWiA	Poznan, 60-631, Poland
Completed	IRCCS Policlinico San Matteo	Pavia, 27100, Italy
Completed	A.O. Osp Circolo e Fond.Macchi	Varese, 21100, Italy
Completed	IRCCS Fondazione San Raffaele	Milano, 20132, Italy
Completed	A.O. di Reggio Emilia	Reggio Emilia, 42100, Italy
Completed	AUSL Piacenza - Emilia Romagna	Piacenza, 29100, Italy
Completed	AUSL Chieti - Abruzzo	Chieti, 66013, Italy
Completed	A.O. di Padova	Padova, 35128, Italy
Completed	A.O.U. di Parma	Parma, 43100, Italy
Completed	Hospital Clínic i Provincial de Barcelona	Barcelona, 08036, Spain
Completed	Hospital de la Santa Creu i de Sant Pau	Barcelona, 08025, Spain
Completed	Hospital Josep Trueta	Girona, 17007, Spain
Terminated	Hospital Lluís Alcanyís de Xátiva	Xàtiva, 46800, Spain
Completed	Hospital de la Mútua de Terrassa	Terrassa, 08221, Spain
Terminated	Hospital de Fuenlabrada	Fuenlabrada, 28942, Spain
Completed	St. Joseph's Health Centre - Toronto	Toronto, M6R 1B5, Canada
Completed	Sunnybrook Health Sciences Centre	Toronto, M4N 3M5, Canada
Completed	St. Boniface General Hospital	Winnipeg, R2H 2A6, Canada
Completed	Ottawa Hospital - Civic Campus	Ottawa, K1Y 4E9, Canada
Completed	UZ Leuven Gasthuisberg	LEUVEN, 3000, Belgium
Completed	AZ Sint-Maarten	DUFFEL, 2570, Belgium
Completed	H. Hartziekenhuis Lier	LIER, 2500, Belgium
Completed	Hôpital Erasme/Erasmus Ziekenhuis	BRUXELLES - BRUSSEL, 1070, Belgium
Completed	London Health Sciences Centre	London, N6A 4G5, Canada
Completed	CU de Mont-Godinne	YVOIR, 5530, Belgium
Completed	Centre Hospitalier Régional de Namur	NAMUR, 5000, Belgium
Completed	CU Saint-Luc/UZ St-Luc	BRUXELLES - BRUSSEL, 1200, Belgium
Completed	CHU de Liège	LIEGE, 4000, Belgium
Completed	Medisch Spectrum Twente, Locatie Ariensplein	ENSCHEDE, 7511 JX, Netherlands
Completed	Isala Klinieken, Locatie Sophia	ZWOLLE, 8025 AB, Netherlands
Completed	Virga Jesse Ziekenhuis	HASSELT, 3500, Belgium
Completed	UZ Gent	GENT, 9000, Belgium
Completed	AZ St-Elisabeth	ZOTTEGEM, 9620, Belgium
Terminated	Ziekenhuis Oost-Limburg	GENK, 3600, Belgium
Terminated	Ikazia Ziekenhuis	ROTTERDAM, 3083 AN, Netherlands
Terminated	Albert Schweitzer Ziekenhuis, locatie Zwijndrecht	ZWIJNDRECHT, 3331 LZ, Netherlands
Completed	Academisch Medisch Centrum Universiteit van Amsterdam	AMSTERDAM, 1105 AZ, Netherlands
Completed	Ziekenhuis Rijnstate	ARNHEM, 6815 AD, Netherlands
Completed	Spaarne Ziekenhuis	HOOFDDORP, 2134 TM, Netherlands
Completed	SU/Östra	Göteborg, 416 85, Sweden
Completed	Södra Älvsborgs Sjukhus	Borås, 501 82, Sweden
Completed	Universitair Medisch Centrum Groningen	GRONINGEN, 9713 GZ, Netherlands
Terminated	Albert Schweitzer Ziekenhuis, Locatie Dordwijk	DORDRECHT, 3318 AT, Netherlands
Completed	Academisch Ziekenhuis Maastricht	MAASTRICHT, 6229 HX, Netherlands
Completed	Länssjukhuset Ryhov	Jönköping, 551 85, Sweden
Completed	Länssjukhuset Sundsvall-Härnösand	Sundsvall, 851 86, Sweden
Terminated	Västerviks Sjukhus	Västervik, 593 81, Sweden
Completed	Aarhus Amstsygehus	Aarhus C, 8000, Denmark
Completed	Bredstrup sygehus	Braedstrup, 8740, Denmark
Completed	Östfold Hospital Trust Fredrikstad	Fredrikstad, 1603, Norway
Completed	Sykehuset Asker og Bærum	Rud, 1309, Norway
Terminated	University of Stellenbosch	CAPE TOWN, 7500, South Africa
Completed	Helderberg Medical Clinical Trials	Somerset West, 7130, South Africa
Completed	University of Witwatersrand	Johannesburg, 2132, South Africa
Completed	Unitas Hospital	Pretoria, 0157, South Africa
Terminated	Unitas Hospital	Pretoria, 0157, South Africa
Terminated	Sahlgrenska Universitetssjukhuset	Göteborg, 413 45, Sweden
Terminated	Gentofte Hospital	Hellerup, 2900, Denmark
Completed	H:S Frederiksberg Hospital	Frederiksberg, 2000F, Denmark
Completed	Ullevål Universitetssykehus	Oslo, 0407, Norway
Completed	St Olav Hospital HF	Trondheim, 7006, Norway
Completed	Sandton Medi Clinic	Johannesburg, 2191, South Africa
Completed	Pretoria Academic Hospital New	Pretoria, 0084, South Africa
Completed	Flora Clinic	Johannesburg, 1724, South Africa
Completed	Clinical Projects Research SA	Worcester, 6850, South Africa
Completed	Sunninghill Hospital	Johannesburg, 2157, South Africa
Terminated	Institut klinicke a experimentalni mediciny	Prague, 140 21, Czech Republic
Completed	Fakultni nemocnice Motol	Prague 5, 150 00, Czech Republic
Completed	N1 City Hospital	Cape Town, 7460, South Africa
Completed	Little Company of Mary Hospital	Pretoria, 0181, South Africa
Terminated	University of Witwatersrand	Johannesburg, 2193, South Africa
Completed	University of Witwatersrand	Johannesburg, 2132, South Africa
Completed	Masaryk Hospital Usti n/L	Usti nad Lebem, 401 13, Czech Republic
Completed	Nemocnice Na Fratisku	Praha 1, 110 00, Czech Republic
Completed	Vseobecna fakultni nemocnice	Praha 2, 12800, Czech Republic
Completed	Hospital Kladno	Kladno, 27259, Czech Republic
Completed	Clalit Health Services - Haemek Medical Center	Afula, 18101, Israel
Completed	Edith Wolfson Medical Center	Holon, 58100, Israel
Completed	Ziv Medical Center	Safed, 13100, Israel
Completed	Sapir Medical Center, Meir General Hospital	Kfar Saba, 44281, Israel
Completed	Bnai Zion Medical Center	Haifa, 31048, Israel
Completed	Mestska nemocnice Ostrava	Ostrava, 728 80, Czech Republic
Completed	Fakultni nemocnice s poliklinikou Ostrava	Ostrava-Poruba, 708 52, Czech Republic
Terminated	Hospital Karlovy Vary	Karlovy Vary, 360 00, Czech Republic
Completed	Rambam Medical Center	Haifa, 31096, Israel
Completed	The Barzilai Medical Center	Ashkelon, 78306, Israel
Completed	Tel Aviv Sourasky Medical Center	Tel Aviv, 64239, Israel
Completed	Kaplan Medical Center	Rehovot, 76100, Israel
Completed	Prince of Wales Hospital	Sydney, 2031, Australia
Completed	Monash Medical Centre	Clayton, 3168, Australia
Terminated	Gold Coast Hospital	Southport, 4215, Australia
Completed	The Canberra Hospital	Garran, 2605, Australia
Completed	Eastern Clinical Research Unit - Box Hill	Box Hill, 3128, Australia
Completed	Lismore Base Hospital	LISMORE, 2480, Australia
Completed	Rabin Medical Center - Beilinson Campus	Petach Tikva, 49100, Israel
Completed	Hadassah University Hospital Ein Kerem	Jerusalem, 91120, Israel
Completed	Lady Davis Carmel Medical Center	Haifa, 34362, Israel
Terminated	Soroka University Medical Center	Beer Sheva, 84101, Israel
Completed	Royal North Shore Hospital	St Leonards, 2065, Australia
Completed	Redcliffe Hospital	Redcliffe, 4020, Australia
Terminated	St Vincents Hospital Sydney	Darlinghurst, 2010, Australia
Completed	Flinders Medical Centre	Adelaide, 5042, Australia
Completed	Princess Alexandra Hospital	Woolloongabba, 4102, Australia
Completed	St George Hospital	Kogarah, 2217, Australia
Completed	Fremantle Hospital	Fremantle, 6160, Australia
Terminated	Queen Elizabeth Hospital	Woodville South, 5011, Australia
Completed	Maroondah Hospital	Melbourne, 3135, Australia
Completed	The Avenue Cardiovascular Centre	Melbourne, 3181, Australia
Completed	Concord Repatriation General Hospital	Sydney, 2139, Australia
Completed	Universitätsklinikum Innsbruck	Innsbruck, 6020, Austria
Completed	Medizinische Universität Graz	Graz, 8036, Austria
Completed	Szent Istvan Hospital	Budapest, 1096, Hungary
Completed	Bacs-Kiskun Country Hospital	Kecskemet, 6000, Hungary
Completed	Flor Ferenc Hospital	Kistarcsa, 2143, Hungary
Completed	Hospital Universitário Cajuru da PUC PR	Curitiba, 80050-350, Brazil
Completed	Conjunto Hospitalar de Sorocaba	Sorocaba, 18031-000, Brazil
Completed	Hospital da Beneficiência Portuguesa	São Paulo, 01323-001, Brazil
Completed	Inst. de Assistência Médica ao Sérvidor Público Estadual	São Paulo, 04039-004, Brazil
Completed	Royal Perth Hospital	Perth, 6000, Australia
Completed	Geelong Hospital	Geelong, 3220, Australia
Completed	Gosford Hospital	Gosford, 2250, Australia
Completed	Sutherland Hospital & Community Health Service	Sydney, 2229, Australia
Completed	Royal Brisbane & Women's Hospital	Brisbane, 4029, Australia
Completed	Allgemeines Krankenhaus der Stadt Wien Universitätskliniken	Wien, 1090, Austria
Terminated	Landeskrankenhaus Salzburg	Salzburg, 5020, Austria
Completed	Hanusch-Krankenhaus Wien	Wien, 1140, Austria
Completed	Landeskrankenhaus Feldkirch	Feldkirch, 6807, Austria
Completed	Hospital Universitário Regional do Norte do Paraná	Londrina, 86038440, Brazil
Terminated	Hosp. Dr Helio Angotti - Assoc. Combate ao Cancer Br Central	Uberaba, 38010 380, Brazil
Completed	Hospital das Clínicas de Botucatu - UNESP Botucatu	Botucatu, 18618 000, Brazil
Completed	General Hospital of People's Libration Army	Beijing, 100853, China
Terminated	Respiratory Diseases Institute, Beijing Chaoyang Hospital	beijing, 100020, China
Completed	Beijing Anzhen Hospital of the Capital University of Medical	Beijing, 100029, China
Completed	Peking Union Medical College Hospital	Beijing, 100730, China
Completed	Cardiovascular institute and Fuwai Hospital, Chinese Academy	Beijing, 100037, China
Completed	Shanghai Pulmonary Hospital, Tongji University	Shanghai, 200433, China
Completed	Borsod County Hospital	Miskolc, 3526, Hungary
Completed	Szent Imre Hospital	Budapest, 1115, Hungary
Completed	University of Debrecen Medical&Health Science Center	Debrecen, 4032, Hungary
Completed	Dr Bugyi Istvan Hospital	Szentes, 6600, Hungary
Completed	Vas Megyei Markusovszky Korhaz	Szombathely, 9700, Hungary
Terminated	UNIFESP/EPM	Sao Paulo, 04023-061, Brazil
Completed	Hospital Universitario Pedro Ernesto	Rio de Janeiro, Brazil
Completed	Hospital do Cancer de Sao Paulo - AC Camargo	Sao Paulo, 01509-900, Brazil
Completed	Vascular Surgical Institute, Shanghai Zhongshan Hospital	Shanghai, 200032, China
Terminated	Beijing Shijitan Hospital	Beijing, 100038, China
Terminated	2nd affiliated Hos. Harbin Medical University	Harbin, 150086, China
Completed	Sir Run Run Shaw Hosp Med College of Zhejiang University	Hangzhou, 310016, China
Completed	Cipto Mangunkusumo Hospital	Jakarta, 10430, Indonesia
Completed	University of Diponegoro, Dr Kariadi Teaching Hospital	Semarang, 50241, Indonesia
Completed	PGI Cikini Hospital	Jakarta, 10330, Indonesia
Completed	Keimyung University Dongsan Medical Center	Taegu, 700-712, Korea, Republic Of
Terminated	Kyungpook National University Hospital	Daegu, 700721, Korea, Republic Of
Terminated	Severance Hospital, Yonsei University College of Medicine	Seoul, 120-752, Korea, Republic Of
Terminated	The Catholic University of Korea Kangnam St. Mary's Hospital	Seoul, 137-701, Korea, Republic Of
Completed	Shanghai Renji Hospital	shanghai, 200001, China
Completed	The First Affiliated Hospital, Sun Yat-Sen University	guangzhou, 510000, China
Completed	Peking University People's Hospital	Beijing, 100044, China
Completed	the People's Hospital of Liaoning Province	shenyang, 110016, China
Completed	Changhai Hospital of Second Military Medical University	Shanghai, 200433, China
Completed	Tongji Hosp Tongji Med College of Huazhong University of Sci	Wuhan, 430022, China
Completed	The 2nd Affiliated Hospital of Soochow University	Suzhou, 215004, China
Terminated	first affiliated hospital of guangzhou medical college	Guangzhou, 510120, China
Completed	Hasan Sadikin Hospital	Bandung, 40161, Indonesia
Completed	Luzerner Kantonsspital	Luzern, 6000, Switzerland
Terminated	Centre Hospitalier Universitaire Vaudois (CHUV)	Lausanne, 1011, Switzerland
Completed	Amrita Institute of Medical Sciences	Kochi, 682026, India
Completed	Veterans General Hospital	Taipei, 112, Taiwan
Completed	Hospital Ampang	Selangor, 68000, Malaysia
Completed	Philippine Heart Centre	Quezon City, 0850, Philippines
Completed	Tan Tock Seng Hospital	Singapore, 308433, Singapore
Completed	St Elisabeth Hospital	Medan, 20152, Indonesia
Completed	Daegu Catholic University Medical Center	Daegu, 705-718, Korea, Republic Of
Terminated	Seoul National University Hospital	Seoul, 110-744, Korea, Republic Of
Completed	Hôpital Cantonal Universitaire de Genève	Genéve 14, 1211, Switzerland
Completed	Universitätsspital Zürich	Zürich, 8091, Switzerland
Completed	Centre Hospitalier Universitaire Vaudois (CHUV)	Lausanne, 1005, Switzerland
Completed	Kantonsspital Graubünden	Chur, 7000, Switzerland
Terminated	Seinäjoen keskussairaala	Seinäjoki, 60220, Finland
Completed	Haematology Service, Canterbury Health Laboratories	Christchurch, 8011, New Zealand
Completed	North Shore Hospital	Auckland, 0622, New Zealand
Completed	Palmerston North Hospital	Palmerston North, 4414, New Zealand
Completed	Ramathibodhi Hospital	Bangkok, 10400, Thailand
Completed	Ruby Hall Clinic	Pune, 411001, India
Terminated	P. D. Hinduja Hospital and Medical Research Centre	Mumbai, 400016, India
Completed	Nizam's Institute of Medical Sciences	Hyderabad, 500082, India
Terminated	AMRI Hospital	Kolkata, 700029, India
Completed	Sir Ganga Ram Hospital	New Delhi, 110060, India
Completed	National Taiwan University Hospital	Taipei, 10016, Taiwan
Terminated	Kaoshiong Medical College Hospital	Kaosiung, 807, Taiwan
Completed	Far Eastern Memorial Hospital	Taipei, 220, Taiwan
Terminated	Taichung Veterans General Hospital	Taichung, 40705, Taiwan
Completed	Queen Mary Hospital, University of Hong Kong	Hong Kong, Hong Kong
Terminated	Cardiovascular Disease &amp; Internal Medicine Ruttonjee Hos.	Wanchai, Hong Kong
Completed	St. Luke's Medical Centre Cathedral Heights	Quezon City, 1102, Philippines
Completed	Singapore General Hospital	Singapore, 169608, Singapore
Completed	Thrombosis Unit	Auckland, 1023, New Zealand
Completed	Middlemore Hospital	Auckland, 2024, New Zealand
Completed	Wellington Hospital	Wellington South, 6021, New Zealand
Completed	Chulalongkorn University Hospital	Pathumwan, Bangkok, 10330, Thailand
Terminated	Siriraj Hospital, Mahidol	Bangkok, 10700, Thailand

Primary Outcome

Percentage of participants with symptomatic recurrent venous thromboembolism [VTE] (i.e. the composite of recurrent deep vein thrombosis [DVT] or fatal or non-fatal pulmonary embolism [PE]) until the intended end of study treatment
Time Frame:
3-, 6- or 12-month study treatment period
Safety Issue:
No

Secondary Outcome

Percentage of participants with the composite variable comprising recurrent DVT, non-fatal PE and all cause mortality until the intended end of study treatment
Time Frame:
3-, 6- or 12-month study treatment period
Safety Issue:
No
Percentage of participants with an event for net clinical benefit 1 until the intended end of study treatment
Time Frame:
3-, 6-, or 12-month study treatment period
Safety Issue:
No
Percentage of participants with recurrent DVT until the intended end of study treatment
Time Frame:
3-, 6- or 12-month study treatment period
Safety Issue:
No
Percentage of participants with clinically relevant bleeding, treatment-emergent (time window: until 2 days after last dose)
Time Frame:
3-, 6- or 12-month study treatment period
Safety Issue:
Yes
Percentage of participants with all deaths
Time Frame:
3-, 6- or 12-month study treatment period
Safety Issue:
Yes
Percentage of participants with other vascular events, on-treatment (time window: until 1 day after last dose)
Time Frame:
3-, 6- or 12-month study treatment period
Safety Issue:
Yes

Trial design

Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Open Label

Assignment

Parallel Assignment

Trial Arms

Additional Information

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