check_circleStudy Completed

Pulmonary Embolism

Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic pulmonary embolism - The EINSTEIN PE 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 pulmonary embolism (PE) with or without symptomatic Deep-Vein Thrombosis (DVT) (Einstein-PE).

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Confirmed acute symptomatic proximal PE with or without symptomatic DVT
  • - 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
4833
Trial Dates
March 2007 - December 2011
Phase
Phase 3
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Klinikum DarmstadtDarmstadt, 64297, Germany
Completed
Klinikum der Eberhard-Karls-Universität TübingenTübingen, 72076, Germany
Completed
SRH Klinikum-Karlsbad-Langensteinbach gGmbHKarlsbad, 76307, Germany
Completed
St. JosefskrankenhausHeidelberg, 69115, Germany
Completed
Klinikum Innenstadt der Ludwigs-Maximilians-UniversitätMünchen, 81377, Germany
Completed
Forschungszentrum Ruhr - KliFoCenter GmbHWitten, 58455, Germany
Completed
Wenckebach-KrankenhausBerlin, 12099, Germany
Completed
Brüderkrankenhaus St. JosefPaderborn, 33098, Germany
Completed
Zentralklinikum AugsburgAugsburg, 86156, Germany
Completed
Universitätsklinikum Hamburg Eppendorf (UKE)Hamburg, 20251, Germany
Completed
Praxis für Innere Medizin u. Gefäßkrankheiten HBEMagdeburg, 39112, Germany
Completed
Klinikum der Johann Wolfgang Goethe Universität FrankfurtFrankfurt, 60590, Germany
Completed
Praxis Hr. Dr. W. MondorfFrankfurt, 60596, Germany
Completed
Medizinische Fakultät Carl Gustav CarusDresden, 01307, Germany
Completed
Praxis Hr. Dr. P. Baron von BilderlingMünchen, 80331, Germany
Completed
Med. Fakultät der Martin-Luther-Universität Halle-WittenbergHalle, 06120, Germany
Completed
Klinikum der Universität WürzburgWürzburg, 97080, Germany
Completed
DiakoniekrankenhausRotenburg, 27342, Germany
Completed
Praxis Hr. Dr. F. HeckmannNeckargemünd, 69151, Germany
Completed
Universitätsklinikum EssenEssen, 45122, Germany
Completed
Fürst Stirum KlinikBruchsal, 76646, Germany
Completed
Klinikum der Ernst-Moritz-Arndt-UniversitätGreifswald, 17475, Germany
Completed
Klinikum der Eberhard-Karls-Universität TübingenTübingen, 72076, Germany
Completed
Medizinische Fakultät Carl Gustav CarusDresden, 01307, Germany
Completed
Johannes-Gutenberg-Universität MainzMainz, 55131, Germany
Completed
Universitätsklinikum HeidelbergHeidelberg, 69120, Germany
Completed
Südharz-Krankenhaus Nordhausen gGmbHNordhausen, 99734, Germany
Completed
Knappschafts-KrankenhausBottrop, 46242, Germany
Completed
Kings College HospitalLondon, SE5 9RS, United Kingdom
Completed
St Thomas' HospitalLondon, SE1 7EH, United Kingdom
Completed
Derriford HospitalPlymouth, PL6 8DH, United Kingdom
Completed
North Middlesex HospitalLondon, United Kingdom
Completed
West Middlesex University HospitalIsleworth, TW7 6AF, United Kingdom
Completed
Bay Pines VA Healthcare SystemBay Pines, 33744, United States
Completed
Spokane Respiratory ConsultantsSpokane, 99204, United States
Completed
Cancer Care Centers of South TexasSan Antonio, 78229, United States
Completed
University of North CarolinaChapel Hill, 27599-7035, United States
Completed
Oklahoma University Health Science CenterOklahoma City, 73104, United States
Completed
Pulmonary Associates of Fredericksburg, Inc.Fredericksburg, 22401, United States
Completed
University of Utah Medical CenterSalt Lake City, 84132, United States
Completed
Lovelace Health SystemsAlbuquerque, 87108, United States
Completed
Beth Israel Deaconess Medical CenterBoston, 02215, United States
Completed
Eastern Idaho Medical ConsultantsIdaho Falls, 83404, United States
Completed
Heritage Cardiology AssociatesCamp Hill, 17011, United States
Completed
San Juan VA Medical CenterSan Juan, 00927, United States
Completed
Moses H. Cone Memorial HospitalGreensboro, 27401, United States
Completed
Covington, 70433, United States
Completed
JRMD, Inc.Redlands, 92373, United States
Completed
Sinai Hospital of BaltimoreBaltimore, 21215, United States
Completed
Wesley Long Community HospitalGreensboro, 27403, United States
Completed
The Western Pennsylvania HospitalPittsburgh, 15224, United States
Completed
Tacoma General HospitalTacoma, 98405, United States
Completed
Jackson Memorial HospitalMiami, 33136-1096, United States
Completed
Intermountain Medical CenterMurray, 84107, United States
Completed
University of MiamiMiami, 33136, United States
Completed
University of Arkansas for Medical SciencesLittle Rock, 72205, United States
Completed
Cardio-Pulmonary AssociatesChesterfield, 63017, United States
Completed
Hôpital Nord-SAINT ETIENNESAINT ETIENNE, 42055, France
Completed
Centre hospitalier Intercommunal - VernonVERNON, 27200, France
Completed
Centre Hospitalier - Valenciennes CedexVALENCIENNES CEDEX, 59322, France
Completed
Hôpital Saint André - BordeauxBORDEAUX, 33000, France
Completed
Hopital Bichat - ParisPARIS, 75877, France
Completed
Hopital Européen Georges Pompidou - ParisPARIS CEDEX 15, 75908, France
Completed
Hôpital Pasteur - NiceNICE, 06002, France
Completed
Hôpital Dupuytren - Limoges CedexLIMOGES, 87042, France
Completed
Hôtel Dieu - ParisPARIS, 75004, France
Completed
Hôpital du Bocage - DijonDIJON, 21000, France
Completed
Hôpital Louis Mourier - Colombes CedexCOLOMBES CEDEX, 92701, France
Completed
Hopital J. Minjoz - BesançonBESANCON, 25000, France
Completed
Hopital Européen Georges Pompidou - ParisPARIS, 75015, France
Completed
Hôpital La Cavale Blanche - Brest CedexBREST CEDEX, 29609, France
Completed
Hôpital Antoine Béclère - ClamartCLAMART, 92141, France
Completed
Centre Hospitalier Universitaire - GrenobleGRENOBLE, 38043, France
Completed
Hôpital Hôtel Dieu - Nantes CedexNANTES, 44000, France
Completed
Hôpital Saint-Eloi - Montpellier CedexMONTPELLIER CEDEX, 34295, France
Completed
Centre Hospitalier Universitaire - AngersANGERS CEDEX 01, 49033, France
Completed
Hôpital Gabriel Montpied - Clermont FerrandCLERMONT FERRAND, 63000, France
Completed
Hôpital Lariboisière - ParisPARIS, 75475, France
Completed
Hôpital Civil - StrasbourgSTRASBOURG CEDEX, 67091, France
Completed
Hopital Général - AgenAGEN CEDEX 9, 47923, France
Completed
Centre Hospitalier Lyon Sud - Pierre BénitePIERRE BENITE, 69495, France
Completed
Centre Hospitalier Universitaire Brabois - Vandoeuvre-les-NaVANDOEUVRE LES NANCY, 54511, France
Completed
Centre Hospitalier - ArrasARRAS, 62000, France
Completed
Hôpital de Rangueil - ToulouseTOULOUSE, 31403, France
Completed
Hôpital Font Pré - ToulonTOULON, 83000, France
Completed
Clinique du ParcCASTELNAU LE LEZ, 34170, France
Completed
Groupe Hospitalier Sud - AmiensAMIENS, 80000, France
Completed
Centre Hospitalier d'OrthezOrthez, 64300, France
Completed
Centre Hospitalier de RoanneRoanne, 42328, France
Completed
Hôpital Charles Nicolle - Rouen CedexROUEN CEDEX, 76031, France
Completed
Centre Hospitalier de la Région d'AnnecyMETZ-TESSY, 74370, France
Completed
Szpital KlinicznyWroclaw, 50-326, Poland
Completed
SP Szpital Kliniczny AM w BialymstokuBialystok, 15-276, Poland
Completed
Wojewodzki Szpital SpecjalistycznyWroclaw, 51-124, Poland
Completed
Szpital Uniwersytecki w KrakowieKrakow, 31-066, Poland
Completed
Szpital KlinicznyWroclaw, 50-326, Poland
Completed
Instytut Gruzlicy i Chorob PlucWarszawa, 01-138, Poland
Completed
Wojewodzki Szpital SpecjalistycznyWroclaw, 51-124, Poland
Completed
SPSK nr 1Lublin, 20-081, Poland
Completed
Szpital im. N. BarlickiegoLodz, 90-153, Poland
Completed
ZOZ MSWiAPoznan, 60-631, Poland
Completed
Szpiatal Kliniczny nr 1 Przemienienia PanskiegoPoznan, 61-848, Poland
Completed
Wojew. Szpital ZespolonyTorun, 87-100, Poland
Completed
Szpital im. N. BarlickiegoLodz, 90-153, Poland
Completed
IRCCS Policlinico San MatteoPavia, 27100, Italy
Completed
A.O. Osp Circolo e Fond.MacchiVarese, 21100, Italy
Completed
AULSS 12 Veneziana - VenetoVenezia, 30122, Italy
Completed
A.O. San Paolo Polo UniversitarioMilano, 20142, Italy
Completed
IRCCS Fondazione San RaffaeleMilano, 20132, Italy
Completed
A.O. di Reggio EmiliaReggio Emilia, 42100, Italy
Completed
AUSL Piacenza - Emilia RomagnaPiacenza, 29100, Italy
Completed
IRCCS Fond. Ca' Granda Ospedale Maggiore PoliclinicoMilano, 20122, Italy
Completed
A.O.U. di BolognaBologna, 40138, Italy
Completed
AUSL 2 Lanciano-Vasto-Chieti - AbruzzoChieti, 66013, Italy
Completed
A.O. di PadovaPadova, 35128, Italy
Completed
A.O.U. di ParmaParma, 43100, Italy
Completed
A.O.U. Policlinico GiacconePalermo, 90127, Italy
Completed
IRCCS Ist Clinico HumanitasRozzano, 20089, Italy
Completed
Hospital Clínic i Provincial de BarcelonaBarcelona, 08036, Spain
Completed
Hospital de la Santa Creu i de Sant PauBarcelona, 08025, Spain
Completed
Hospital Josep TruetaGirona, 17007, Spain
Completed
Hospital Ramón y CajalMadrid, 28034, Spain
Completed
Hospital Virgen del CaminoPamplona, 31008, Spain
Completed
Hospital de la Mútua de TerrassaTerrassa, 08221, Spain
Completed
Hospital Universitari Son EspasesPalma de Mallorca, 07010, Spain
Completed
Hospital del Rio HortegaValladolid, 47010, Spain
Completed
Hospital General de RequenaRequena, 46340, Spain
Completed
St. Joseph's Health Centre - TorontoToronto, M6R 1B5, Canada
Completed
London Health Sciences CentreLondon, N6A 4G5, Canada
Completed
Sunnybrook Health Sciences CentreToronto, M4N 3M5, Canada
Completed
St. Boniface General HospitalWinnipeg, R2H 2A6, Canada
Completed
Ottawa Hospital - Civic CampusOttawa, K1Y 4E9, Canada
Completed
UZ Leuven GasthuisbergLEUVEN, 3000, Belgium
Completed
CU de Mont-GodinneYVOIR, 5530, Belgium
Completed
AZ Sint-MaartenDUFFEL, 2570, Belgium
Completed
H. Hartziekenhuis LierLIER, 2500, Belgium
Completed
Centre Hospitalier Régional de NamurNAMUR, 5000, Belgium
Completed
CU Saint-Luc/UZ St-LucBRUXELLES - BRUSSEL, 1200, Belgium
Completed
Hôpital Erasme/Erasmus ZiekenhuisBRUXELLES - BRUSSEL, 1070, Belgium
Completed
CHU de LiègeLIEGE, 4000, Belgium
Completed
Virga Jesse ZiekenhuisHASSELT, 3500, Belgium
Completed
UZ GentGENT, 9000, Belgium
Completed
AZ St-ElisabethZOTTEGEM, 9620, Belgium
Completed
Ziekenhuis Oost-LimburgGENK, 3600, Belgium
Completed
OL Vrouwziekenhuis - Campus AalstAALST, 9300, Belgium
Completed
CHR de la CitadelleLIEGE, 4000, Belgium
Completed
Medisch Spectrum Twente, Locatie ArienspleinENSCHEDE, 7511 JX, Netherlands
Completed
Isala Klinieken, Locatie SophiaZWOLLE, 8025 AB, Netherlands
Completed
Universitair Medisch Centrum GroningenGRONINGEN, 9713 GZ, Netherlands
Completed
Academisch Medisch Centrum Universiteit van AmsterdamAMSTERDAM, 1105 AZ, Netherlands
Completed
Ziekenhuis RijnstateARNHEM, 6815 AD, Netherlands
Completed
Spaarne ZiekenhuisHOOFDDORP, 2134 TM, Netherlands
Completed
Academisch Ziekenhuis MaastrichtMAASTRICHT, 6229 HX, Netherlands
Completed
SU/ÖstraGöteborg, 416 85, Sweden
Completed
Länssjukhuset RyhovJönköping, 551 85, Sweden
Completed
Södra Älvsborgs SjukhusBorås, 501 82, Sweden
Completed
Sahlgrenska UniversitetssjukhusetGöteborg, 413 45, Sweden
Completed
Länssjukhuset SundsvallSundsvall, 851 86, Sweden
Completed
SödersjukhusetStockholm, 118 83, Sweden
Completed
H:S Frederiksberg HospitalFrederiksberg, 2000F, Denmark
Completed
Aarhus AmstsygehusAarhus C, 8000, Denmark
Completed
Bredstrup sygehusBraedstrup, 8740, Denmark
Completed
Östfold Hospital Trust FredrikstadFredrikstad, 1603, Norway
Completed
Sykehuset Asker og BærumRud, 1309, Norway
Completed
Ullevål UniversitetssykehusOslo, 0407, Norway
Completed
St Olav Hospital HFTrondheim, 7006, Norway
Completed
Sandton Medi ClinicJohannesburg, 2191, South Africa
Completed
Pretoria Academic Hospital NewPretoria, 0084, South Africa
Completed
Helderberg Medical Clinical TrialsSomerset West, 7130, South Africa
Completed
Mayo ClinicRoodepoort, 1724, South Africa
Completed
University of WitwatersrandJohannesburg, 2132, South Africa
Completed
Clinical Projects Research SAWorcester, 6850, South Africa
Completed
Unitas HospitalPretoria, 0157, South Africa
Completed
Unitas HospitalPretoria, 0157, South Africa
Completed
N1 City HospitalCape Town, 7460, South Africa
Completed
Little Company of Mary HospitalPretoria, 0181, South Africa
Completed
Sunninghill HospitalJohannesburg, 2157, South Africa
Completed
University of WitwatersrandJohannesburg, 2132, South Africa
Completed
Fakultni nemocnice MotolPrague 5, 150 00, Czech Republic
Completed
Mestska nemocnice OstravaOstrava, 728 80, Czech Republic
Completed
Fakultni nemocnice s poliklinikou OstravaOstrava-Poruba, 708 52, Czech Republic
Completed
Masaryk Hospital Usti n/LUsti nad Lebem, 401 13, Czech Republic
Completed
Nemocnice Na FratiskuPraha 1, 110 00, Czech Republic
Completed
Vseobecna fakultni nemocnicePraha 2, 12800, Czech Republic
Completed
Hospital KladnoKladno, 27259, Czech Republic
Completed
Centralni nemocnice RakovnikRakovnik, 269 01, Czech Republic
Completed
Haemek Medical CenterAfula, 18101, Israel
Completed
Edith Wolfson Medical CenterHolon, 58100, Israel
Completed
Rambam Medical CenterHaifa, 31096, Israel
Completed
Ziv Medical CenterSafed, 13100, Israel
Completed
Meir Medical CenterKfar Saba, 44281, Israel
Completed
Barzilai Medical CenterAshkelon, 78278, Israel
Completed
Bnai Zion Medical CenterHaifa, 31048, Israel
Completed
Rabin Medical Center - Beilinson CampusPetach Tikva, 49100, Israel
Completed
Hadassah University Hospital Ein KeremJerusalem, 91120, Israel
Completed
Tel Aviv Sourasky Medical CenterTel Aviv, 64239, Israel
Completed
Lady Davis Carmel Medical CenterHaifa, 34362, Israel
Completed
Kaplan Medical CenterRehovot, 76100, Israel
Completed
Prince of Wales HospitalSydney, 2031, Australia
Completed
Royal North Shore HospitalSt Leonards, 2065, Australia
Completed
Redcliffe HospitalRedcliffe, 4020, Australia
Completed
Flinders Medical CentreAdelaide, 5042, Australia
Completed
Princess Alexandra HospitalWoolloongabba, 4102, Australia
Completed
St George HospitalKogarah, 2217, Australia
Completed
Fremantle HospitalFremantle, 6160, Australia
Completed
Monash Medical CentreClayton, 3168, Australia
Completed
Queen Elizabeth HospitalWoodville South, 5011, Australia
Completed
Maroondah HospitalMelbourne, 3135, Australia
Completed
The Avenue Cardiovascular CentreMelbourne, 3181, Australia
Completed
Gold Coast HospitalSouthport, 4215, Australia
Completed
Concord Repatriation General HospitalSydney, 2139, Australia
Completed
Royal Perth HospitalPerth, 6000, Australia
Completed
The Canberra HospitalGarran, 2605, Australia
Completed
Geelong HospitalGeelong, 3220, Australia
Completed
Gosford HospitalGosford, 2250, Australia
Completed
Sutherland Hospital & Community Health ServiceSydney, 2229, Australia
Completed
Eastern Clinical Research Unit - Box HillBox Hill, 3128, Australia
Completed
Lismore Base HospitalLISMORE, 2480, Australia
Completed
Royal Brisbane & Women's HospitalBrisbane, 4029, Australia
Completed
Launceston General HospitalLaunceston, 7250, Australia
Completed
The St George Private HospitalKogarah, 2217, Australia
Completed
Allgemeines Krankenhaus der Stadt Wien UniversitätsklinikenWien, 1090, Austria
Completed
Hanusch-Krankenhaus WienWien, 1140, Austria
Completed
Universitätsklinikum InnsbruckInnsbruck, 6020, Austria
Completed
Landeskrankenhaus FeldkirchFeldkirch, 6807, Austria
Completed
Medizinische Universität GrazGraz, 8036, Austria
Terminated
Wilhelminenspital der Stadt WienWien, 1171, Austria
Completed
Krankenhaus der Elisabethinen LinzLinz, 4010, Austria
Completed
Szent Istvan HospitalBudapest, 1096, Hungary
Completed
Bacs-Kiskun Country HospitalKecskemet, 6000, Hungary
Completed
Borsod County HospitalMiskolc, 3526, Hungary
Completed
Szent Imre HospitalBudapest, 1115, Hungary
Completed
University of Debrecen Medical&Health Science CenterDebrecen, 4032, Hungary
Completed
Flor Ferenc HospitalKistarcsa, 2143, Hungary
Completed
Dr Bugyi Istvan HospitalSzentes, 6600, Hungary
Completed
Vas Megyei Markusovszky KorhazSzombathely, 9700, Hungary
Completed
Tolna County HospitalSzekszard, 7100, Hungary
Completed
Zala Megyei KorhazZalaegerszeg, 8900, Hungary
Completed
Hospital Universitário Cajuru da PUC PRCuritiba, 80050-350, Brazil
Completed
Conjunto Hospitalar de SorocabaSorocaba, 18031-000, Brazil
Completed
Hospital da Beneficiência PortuguesaSão Paulo, 01323-001, Brazil
Terminated
Casa de Saúde Santa MarcelinaSão Paulo, 08270-070, Brazil
Completed
Hospital Universitario Pedro ErnestoRio de Janeiro, Brazil
Completed
Inst. de Assistência Médica ao Sérvidor Público EstadualSão Paulo, 04039-004, Brazil
Completed
Hospital Universitário Regional do Norte do ParanáLondrina, 86038440, Brazil
Completed
Hospital do Cancer de Sao Paulo - A. C. CamargoSao Paulo, 01509-900, Brazil
Completed
Hospital das Clínicas de Botucatu - UNESP BotucatuBotucatu, 18618 000, Brazil
Completed
Vascular Surgical Institute, Shanghai Zhongshan HospitalShanghai, 200032, China
Completed
Shanghai Renji Hospitalshanghai, 200001, China
Completed
The First Affiliated Hospital of Sun Yat-Sen Universityguangzhou, 510080, China
Completed
Chinese PLA General Hosp.Beijing, 100853, China
Completed
Respiratory Diseases Institute, Beijing Chaoyang Hospitalbeijing, 100020, China
Completed
Beijing Anzhen Hospital of the Capital University of MedicalBeijing, 100029, China
Completed
Peking Union Medical College HospitalBeijing, 100730, China
Completed
Peking Univ. People's Hosp.Beijing, 100044, China
Completed
the People's Hospital of Liaoning Provinceshenyang, 110016, China
Completed
Cardiovascular Institute and Fuwai Hospital, CAMS & PUMCBeijing, 100037, China
Completed
Changhai Hospital of Second Military Medical UniversityShanghai, 200433, China
Completed
Tongji Hosp. of Huazhong Univ. of Science & TechnologyWuhan, 430022, China
Completed
The 2nd Affiliated Hospital of Soochow UniversitySuzhou, 215004, China
Completed
Shanghai Pulmonary Hospital, Tongji UniversityShanghai, 200433, China
Completed
Beijing Shijitan HospitalBeijing, 100038, China
Completed
2nd affiliated Hos. Harbin Medical UniversityHarbin, 150086, China
Completed
Sir Run Run Shaw Hosp Med College of Zhejiang UniversityHangzhou, 310016, China
Completed
first affiliated hospital of guangzhou medical collegeGuangzhou, 510120, China
Completed
Beijing Anzhen Hospital of the Capital University of MedicalBeijing, 100029, China
Completed
The First Affiliated Hospital of Sun Yat-Sen UniversityGuangzhou, China
Completed
People's Hospital of Guangxi Zhuang Autonomous RegionNanning, 530021, China
Completed
Cipto Mangunkusumo HospitalJakarta, 10430, Indonesia
Completed
Hasan Sadikin HospitalBandung, 40161, Indonesia
Completed
University of Diponegoro, Dr Kariadi Teaching HospitalSemarang, 50241, Indonesia
Completed
St Elisabeth HospitalMedan, 20152, Indonesia
Completed
PGI Cikini HospitalJakarta, 10330, Indonesia
Completed
Daegu Catholic University Medical CenterDaegu, 705-718, Korea, Republic Of
Completed
Keimyung University Dongsan Medical CenterTaegu, 700-712, Korea, Republic Of
Completed
Seoul National University HospitalSeoul, 110-744, Korea, Republic Of
Completed
Severance Hospital, Yonsei University College of MedicineSeoul, 120-752, Korea, Republic Of
Completed
Kaunas Medical University HospitalKaunas, LT-50009, Lithuania
Completed
University Hospital of Vilnus CityVilnius, LT-08661, Lithuania
Completed
Luzerner KantonsspitalLuzern, 6000, Switzerland
Completed
Hôpital Cantonal Universitaire de GenèveGenéve 14, 1211, Switzerland
Completed
Universitätsspital ZürichZürich, 8091, Switzerland
Completed
Centre Hospitalier Universitaire Vaudois (CHUV)Lausanne, 1011, Switzerland
Completed
Centre Hospitalier Universitaire Vaudois (CHUV)Lausanne, 1005, Switzerland
Completed
Kantonsspital GraubündenChur, 7000, Switzerland
Completed
Inselspital BernBern, 3010, Switzerland
Completed
Tampereen yliopistollinen sairaala, keskussairaalaTampere, 33521, Finland
Completed
Turun yliopistollinen keskussairaala, kantasairaalaTurku, 20520, Finland
Completed
Ruby Hall ClinicPune, 411001, India
Completed
Nizam's Institute of Medical SciencesHyderabad, 500082, India
Completed
Sir Ganga Ram HospitalNew Delhi, 110060, India
Completed
Amrita Institute of Medical SciencesKochi, 682026, India
Completed
National Taiwan University HospitalTaipei, 10016, Taiwan
Completed
Veterans General HospitalTaipei, 112, Taiwan
Completed
Far Eastern Memorial HospitalTaipei, 220, Taiwan
Completed
Taichung Veterans General HospitalTaichung, 40705, Taiwan
Completed
East Tallinn Central HospitalTallinn, 10138, Estonia
Completed
Queen Mary HospitalHong Kong, Hong Kong
Completed
Cardiovascular Disease & Internal Medicine Ruttonjee Hos.Wanchai, Hong Kong
Completed
Hospital AmpangSelangor, 68000, Malaysia
Completed
Philippine Heart CentreQuezon City, 0850, Philippines
Completed
St. Luke's Medical Centre Cathedral HeightsQuezon City, 1102, Philippines
Completed
Tan Tock Seng HospitalSingapore, 308433, Singapore
Completed
Singapore General HospitalSingapore, 169608, Singapore
Completed
Haematology Service, Canterbury Health LaboratoriesChristchurch, 8011, New Zealand
Completed
North Shore HospitalAuckland, 0622, New Zealand
Completed
Thrombosis UnitAuckland, 1023, New Zealand
Completed
Middlemore HospitalAuckland, 2024, New Zealand
Completed
Palmerston North HospitalPalmerston North, 4414, New Zealand
Completed
Wellington HospitalWellington South, 6021, New Zealand
Completed
Chulalongkorn University HospitalPathumwan, Bangkok, 10330, Thailand
Completed
Ramathibodhi HospitalBangkok, 10400, Thailand
Completed
Maharaj Nakorn Chiang Mai HospitalChiang Mai, 50200, Thailand
Completed
Hospital Ntra. Sra. de MeritxellEscaldes - Engordany, Andorra
Completed
Liepajas regionala slimnicaLiepaja, LV 3414, Latvia
Completed
Portiuncula HospitalBallinasloe, Ireland

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