check_circleStudy Completed

Venous Thromboembolism

Bayer Identifier:

11354

ClinicalTrials.gov Identifier:

NCT00329628

EudraCT Number:

Not Available

EU CT Number:

Not Available
Rivaroxaban (10mg) given once daily in patients undergoing Total Hip replacement compared to Enoxaparin

Trial purpose

The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and prevent blood clot which may form after total hip replacement operation.

Key Participants Requirements

Sex

Both

Age

18 Years

  • - Male and female patients aged 18 years or above
    - Patients scheduled for elective total hip replacement
  • - Planned, staged total bilateral hip replacement
    - Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin
    - Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin
    - Conditions prohibiting bilateral venography (e.g. amputation of one leg, allergy to contrast media)

Trial summary

Enrollment Goal
4541
Trial Dates
February 2006 - March 2007
Phase
Phase 3
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Kreiskrankenhaus RheinfeldenRheinfelden, 79618, Germany
Completed
Sana KlinikenSommerfeld, 16766, Germany
Completed
Medizinische Einrichtungen der Heinrich-Heine-UniversitätDüsseldorf, 40225, Germany
Completed
Orthopädische Universitätsklinik - FriedrichsheimFrankfurt, 60528, Germany
Completed
Klinikum FürthFürth, 90766, Germany
Completed
Asklepios Klinik BirkenwerderBirkenwerder, 16547, Germany
Completed
Center for Joint CareMissoula, 59802, United States
Completed
Charleston Orthopaedic AssociatesCharleston, 29414, United States
Completed
Arizona Research Center, Inc.Phoenix, 85023, United States
Completed
Lubbock Sports MedicineLubbock, 79410, United States
Completed
Carrell ClinicDallas, 75231, United States
Completed
Unlimited Research, LPSan Antonio, 78233, United States
Completed
Texas Orthopedic SpecialistsGrapevine, 76051, United States
Completed
Capstone Clinical Trials, Inc.Birmingham, 35205, United States
Completed
Hôpital de HautepierreVANDOEUVRE LES NANCY, 54511, France
Completed
Städtische Kliniken Frankfurt am Main / HoechstFrankfurt, 65929, Germany
Completed
Klinikum Garmisch-PartenkirchenGarmisch-Partenkirchen, 82467, Germany
Completed
Medizinische Fakultät Carl Gustav CarusDresden, 01307, Germany
Completed
Klinikum der Philipps-UniversitätMarburg, 35043, Germany
Completed
Caritas Krankenhaus GmbHBad Mergentheim, 97980, Germany
Completed
Orthopädische Klinik König-Ludwig-HausWürzburg, 97080, Germany
Completed
Aukammklinik für operative RheumatologieWiesbaden, 65191, Germany
Completed
OlgahospitalStuttgart, 70176, Germany
Completed
Universität Rostock - Medizinische FakultätRostock, 18057, Germany
Completed
Universitätsklinikum HeidelbergHeidelberg, 69112, Germany
Completed
Klinikum Bremen Mitte gGmbHBremen, 28205, Germany
Completed
Universität Witten/HerdeckeWitten, 58448, Germany
Completed
West Alabama Research, Inc.Northport, 35476, United States
Completed
Scripps Center of Orthopaedic Research & EducationLa Jolla, 92037, United States
Completed
Institut Montsouris - ParisPARIS CEDEX 14, 75877, France
Completed
Clinique les Maussins-Nollet - ParisPARIS CEDEX 19, 75019, France
Completed
Clinique du Cèdre - Bois GuillaumeBOIS-GUILLAUME, 76230, France
Completed
Clinique Océane - VannesVANNES, 56000, France
Completed
Samodzielny Publiczny Szpital Kliniczny nr 4Lublin, 20-090, Poland
Completed
SP Szpital Kliniczny AM w BialymstokuBialystok, 15-276, Poland
Completed
V Wojskowy Szpital Kliniczny i Poliklinika SPZOZKrakow, 30-901, Poland
Completed
Szpital Uniwersytecki im. Antoniego JuraszaBydgoszcz, 85-094, Poland
Completed
Szpital Specjalistyczny im. Zeromskiego SPZOZKrakow, 31-913, Poland
Completed
Wojewodzki Szpital Brodnowski SPZOZWarszawa, 03-242, Poland
Completed
Wojew. Centrum Ortopedii i Rehabilitacji Narz¿du RuchuLodz, 91-002, Poland
Completed
10 Wojskowy Szpital KlinicznyBydgoszcz, 85-681, Poland
Completed
AUSL 1 Perugia - UmbriaGubbio, 06024, Italy
Completed
A.O. di Reggio EmiliaReggio Emilia, 42100, Italy
Completed
A.O. Ospedale Circolo Busto ArBusto Arsizio, 21052, Italy
Completed
Atlanta Knee and Sports MedicineDecatur, 30033, United States
Completed
Capstone Clinical Trials, Inc.Birmingham, 35205, United States
Completed
Colorado Orthopaedic Consultants, PCAurora, 80012, United States
Completed
Saline Memorial HospitalBenton, 72015, United States
Completed
Diaconesses Croix Saint Simon - ParisPARIS CEDEX 20, 75960, France
Completed
Polyclinique de l'Atlantique - Saint HerblainSAINT HERBLAIN, 44819, France
Completed
Centre Hospitalier Mignot - Le ChesnayLE CHESNAY, 78150, France
Completed
Polyclinique de Riaumont - LievinLIEVIN, 62806, France
Completed
Centre clinical - SoyauxSOYAUX, 16800, France
Completed
Nouvelles Cliniques Nantaises - NantesNANTES CEDEX 2, 44277, France
Completed
Institut Médical des Sciences et du Sport - MonacoMONACO, 98000, France
Completed
Cochin - ParisPARIS, 75674, France
Completed
Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZLublin, 20-718, Poland
Completed
Wojewodzki Szpital Specjalistyczny im. RydygieraKrakow, 31-826, Poland
Completed
Wojskowy Instytut MedycznyWarszawa, 00-909, Poland
Completed
A.O.U. Ospedali Riuniti AnconaAncona, 60126, Italy
Completed
A.O. Ospedali Riuniti BergamoBergamo, 24128, Italy
Completed
A.O.U. di FerraraFerrara, 44100, Italy
Completed
Policlinico Universitario SassariSassari, 07100, Italy
Completed
A.O. Osp Niguarda Ca' GrandaMilano, 20162, Italy
Completed
A.O.U. San MartinoGenova, 16132, Italy
Completed
Complesso Integrato ColumbusRoma, 00168, Italy
Completed
C.T.O. Università degli Studi di FirenzeFirenze, 50139, Italy
Completed
Hospital Clínic i Provincial de BarcelonaBarcelona, 08036, Spain
Completed
Hospital Universitari Germans Trias i PujolBadalona, 08916, Spain
Completed
Hospital Clínico Universitario de ValenciaValencia, 46010, Spain
Completed
Complejo Hospitalario de JaénJaén, 23007, Spain
Completed
Hospital Clínico Universitario San CarlosMadrid, 28040, Spain
Completed
Clínica Universitaria de NavarraPamplona, 31008, Spain
Completed
Hospital del MarBarcelona, 08003, Spain
Completed
Hospital General de CastellóCastellón de la Plana, 12004, Spain
Completed
Szpital Kliniczny Dzieciatka Jezus -Centrum Leczenia ObrazenWarszawa, 02-005, Poland
Completed
SP Szpital Kliniczny nr 1 PAMSzczecin, 71-252, Poland
Completed
Wielkop. Centrum Ortopedii i Chirurgii UrazowejPoznan, 60-703, Poland
Completed
Wojewodzki Szpital Specjalistyczny nr 5Sosnowiec, 41-200, Poland
Completed
SP Szpital Kliniczny nr 7 Slaskiego Uniwersytetu MedycznegoKatowice, 40-635, Poland
Completed
Wojewodzki Szpital Specjalistyczny im. M. KopernikaGdansk, 80-803, Poland
Completed
Rehabilitacyjno-Ortopedyczny Zespó¿ Opieki ZdrowotnejWroclaw, 51-128, Poland
Completed
Szpital WojewodzkiOpole, 45-060, Poland
Completed
A.O. San Gerardo di MonzaMonza, 20052, Italy
Completed
IRCCS Ist Clinico HumanitasRozzano, 20089, Italy
Completed
IRCCS Ist Ortopedico RizzoliBologna, 40136, Italy
Completed
IRCCS Fondazione San RaffaeleMilano, 20132, Italy
Completed
A.O.U. Policlinico GiacconePalermo, 90129, Italy
Completed
AUSL 1 SS Ospedale MarinoAlghero, 07041, Italy
Completed
A.O. CTO-CRF-Maria AdelaideTorino, 10126, Italy
Completed
Gruppo Ospedaliero San DonatoSan Donato Milanese, 20097, Italy
Completed
Clínica PlatónBarcelona, 08006, Spain
Completed
Hospital Dos de Maig - Consorci Sanitari IntegralBarcelona, 08025, Spain
Completed
Hospital General de L'HospitaletL'Hospitalet de llobregat, 08906, Spain
Completed
ADA Medical, Ltd.Oshawa, L1J 2J2, Canada
Completed
Hopital St-Francois d'Assise-CHUQQuebec, G1L 3L5, Canada
Completed
Peterborough Regional Health CentrePeterborough, K9J 7C6, Canada
Completed
Montreal General HospitalMontreal, H3G 1A4, Canada
Completed
Grand River HospitalKitchener, N2G 1G3, Canada
Completed
University of AlbertaEdmonton, T6G 2B7, Canada
Completed
Stratford General HospitalStratford, N5A 2Y6, Canada
Completed
UZ Leuven PellenbergPELLENBERG, 3212, Belgium
Completed
Jan Palfijn ZiekenhuisMERKSEM, 2170, Belgium
Completed
AZ St-Jan BruggeBRUGGE, 8000, Belgium
Completed
AZ KlinaBRASSCHAAT, 2930, Belgium
Completed
Tergooiziekenhuizen HilversumHILVERSUM, 1213 XZ, Netherlands
Completed
Spaarne ZiekenhuisHOOFDDORP, 2134 TM, Netherlands
Completed
Università Cattolica RomaRoma, 00168, Italy
Completed
A.O. Osp Circolo e Fond.MacchiVarese, 21100, Italy
Completed
Ciutat Sanitària i Universitaria de la Vall d'HebrónBarcelona, 08035, Spain
Completed
Fundación Hospital AlcorcónAlcorcón, 28922, Spain
Completed
Hospital Clínico Universitario de Santiago de CompostelaSantiago de Compostela, 15706, Spain
Completed
Hospital TxagorritxuVitoria, 01009, Spain
Completed
Hospital Central de AsturiasOviedo, 33006, Spain
Completed
St. Mary's Hospital CenterMontreal, H3T 1M5, Canada
Completed
Oakville-Trafalgar Memorial HospitalOakville, L6J 3L7, Canada
Completed
ZNA MiddelheimANTWERPEN, 2020, Belgium
Completed
Virga Jesse ZiekenhuisHASSELT, 3500, Belgium
Completed
Ziekenhuis Oost-LimburgGENK, 3600, Belgium
Completed
Stedelijk ZiekenhuisROESELARE, 8800, Belgium
Completed
AZ H. FamilieREET, 2840, Belgium
Completed
CHR de HuyHUY, 4500, Belgium
Completed
St. MaartenskliniekNIJMEGEN, 6522 JV, Netherlands
Completed
DiaconessenhuisLEIDEN, 2334 CK, Netherlands
Completed
Academisch Medisch Centrum Universiteit van AmsterdamAMSTERDAM, 1105 AZ, Netherlands
Completed
Bernhoven ZiekenhuisOSS, 5342 BT, Netherlands
Not yet recruiting
Hospital de Traumatologia y Ortopedia Lomas Verdes IMSSEdo. de Mexico, 53120, Mexico
Completed
Sjukhuset i VarbergVarberg, 432 81, Sweden
Completed
Skaraborgs Sjukhus LidköpingLidköping, 531 85, Sweden
Completed
Länssjukhuset RyhovJönköping, 551 85, Sweden
Completed
Gentofte HospitalHellerup, 2900, Denmark
Completed
Notodden sykehusNotodden, NO-3675, Norway
Completed
Sykehuset Innlandet HF GjøvikGjövik, 2819, Norway
Completed
Martina Hansens HospitalBaerum postterminal, 1306, Norway
Completed
Pretoria Academic Hospital Ethics CommitteePretoria, 0084, South Africa
Completed
Ustredni vojenska nemocnice PrahaPraha 6, 169 02, Czech Republic
Completed
Faculty Hospital Hradec KraloveHradec Kralove, 500 05, Czech Republic
Completed
Fakultni nemocnice PlzenPlzen, 304 60, Czech Republic
Completed
Okresni nemocnice Jindrichuv HradecJindrichuv Hradec, 377 38, Czech Republic
Completed
Nemocnice Ceske BudejoviceCeske Budejovice, 370 87, Czech Republic
Completed
Isala Klinieken, lokatie WeezenlandenZWOLLE, 8011 JW, Netherlands
Not yet recruiting
Hospital Regional ISSSTE MonterreyMonterrey, 64380, Mexico
Not yet recruiting
Hospital Universitario "José Eleuterio González"Monterrey, 64460, Mexico
Completed
SU/ÖstraGöteborg, 416 85, Sweden
Completed
LänssjukhusetHalmstad, 301 85, Sweden
Completed
Västerviks SjukhusVästervik, 593 81, Sweden
Completed
Nordsjællands Hospital - HørsholmHørsholm, DK-2970, Denmark
Completed
Regionshospitalet SilkeborgSilkeborg, 8600, Denmark
Completed
Herlev HospitalHerlev, 2730, Denmark
Completed
H:S Frederiksberg HospitalFrederiksberg, 2000, Denmark
Completed
Sykehuset Innlandet HF LillehammerLillehammer, 2609, Norway
Completed
Sykehuset Innlandet HF ElverumElverum, 2409, Norway
Completed
Vergelegen Medi-ClinicSomerset West, 7130, South Africa
Completed
Clinical Projects Research SAWorcester, 6850, South Africa
Completed
Oblastni nemocnice Mlada BoleslavMlada Boleslav, 293 50, Czech Republic
Completed
Oblastni Nemocnice PribramPribram I, 261 26, Czech Republic
Completed
Nemocnice ProstejovProstejov, 796 04, Czech Republic
Completed
Rambam Medical CenterHaifa, 31096, Israel
Completed
Rabin Medical Center - Beilinson CampusPetach Tikva, 49100, Israel
Completed
Eastern Clinical Research Unit - Box HillMelbourne, 3128, Australia
Completed
St George HospitalSydney, 2217, Australia
Completed
Fremantle HospitalFremantle, 6160, Australia
Completed
Hospital Municipal de Berazatequi Evita PuebloBerazategui, 1884, Argentina
Completed
Hospital AlvarezBuenos Aires, C1406FWY, Argentina
Completed
Sanatorio MitreBuenos Aires, C1039AAO, Argentina
Completed
Sanatorio Regional UOM AvellanedaAvellaneda, 1870, Argentina
Completed
Hospital FernándezBuenos Aires, C1425AGP, Argentina
Completed
Universitätsklinikum InnsbruckInnsbruck, 6020, Austria
Completed
Allgem. öffentl. Krankenhaus Wiener NeustadtWiener Neustadt, 2700, Austria
Completed
A.ö. Krankenhaus der Stadt LinzLinz, 4020, Austria
Completed
KH d. Barmherzigen Schwestern Ried Betriebsges.m.b.H.Ried, 4910, Austria
Completed
Hospital Karlovy VaryKarlovy Vary, 360 66, Czech Republic
Completed
Fakultni Nemocnice OlomoucOlomouc, 775 20, Czech Republic
Completed
Assaf Harofeh Medical CenterZerifin, 70300, Israel
Completed
Tel Aviv Sourasky Medical CenterTel Aviv, 64239, Israel
Completed
Sapir Medical Center, Meir General HospitalKfar Saba, 44281, Israel
Completed
Edith Wolfson Medical CenterHolon, 58100, Israel
Completed
Soroka University Medical CenterBeer Sheva, 84101, Israel
Completed
Chaim Sheba Medical CenterTel Hashomer, 52621, Israel
Completed
The Avenue Cardiovascular CentreMelbourne, 3181, Australia
Completed
Flinders Medical CentreAdelaide, 5042, Australia
Completed
Hospital BritánicoBuenos Aires, C1280AEB, Argentina
Completed
Hospital Militar Central "CIR. MY. C. Argerich"Buenos Aires, 1426, Argentina
Completed
Medizinische Universität GrazGraz, 8036, Austria
Completed
SMZ Baumgartner Höhe Otto Wagner SpitalWien, 1140, Austria
Completed
Klinikum Kreuzschwestern Wels GmbHWels, 4600, Austria
Completed
Hospital San JoséSantiago, Chile
Completed
Hospital del Trabajador de SantiagoSantiago, Chile
Completed
Petz Aladar Megyei KorhazGyör, 9024, Hungary
Completed
Peterfy Sandor utcai Korhaz - RendelointezetBudapest, 1076, Hungary
Completed
Tolna County HospitalSzekszard, 7100, Hungary
Completed
Dokuz Eylul UniversitesiIzmir, 35340, Turkey
Completed
Istanbul Univ. Medical FacultyIstanbul, 34093, Turkey
Completed
Attikon University General Hospital of AtticaHaidari, 12462, Greece
Completed
KAT General Hospital of AthensKifisia, 14561, Greece
Completed
Inst. de Assistência Médica ao Sérvidor Público EstadualSão Paulo, 04039-004, Brazil
Completed
Hospital de Traumáto-Ortopedia - INTORio de Janeiro, 20 232 092, Brazil
Completed
Santa Casa de Misericordia de Porto AlegrePorto Alegre, 90470 340, Brazil
Completed
Pontificia Universidade Católica - Centro ClínicoPorto Alegre, 90610-000, Brazil
Completed
Kaunas Medical University HospitalKaunas, LT-50166, Lithuania
Completed
Mikkelin keskussairaalaMikkeli, FIN-50100, Finland
Completed
Seinäjoen keskussairaalaSeinäjoki, FIN 60220, Finland
Completed
Krankenhaus der Barmherzigen Schwestern LinzLinz, 4010, Austria
Completed
Szeged University Medical SchoolSzeged, 6725, Hungary
Completed
Bacs-Kiskun Country HospitalKecskemet, 6000, Hungary
Completed
Fejer megyei Szent Gyorgy KorhazSzekesfehervar, 8000, Hungary
Completed
Bekes County Hospital "Rethy Pal"Bekescsaba, 5600, Hungary
Completed
Somogy County Hospital "Kaposi Mor"Kaposvar, 7400, Hungary
Completed
University of SemmelweisBudapest, 1089, Hungary
Completed
MoH Goztepe Trainning HospitalIstanbul, 34722, Turkey
Completed
Marmara University Medical FacultyIstanbul, 34662, Turkey
Completed
Cukurova Universitesi Tip Fakultesi HastanesiAdana, 01330, Turkey
Completed
Centro de Investigación Clínica FOQUSBogotá, Colombia
Completed
Fundación CardioinfantilBogotá, Colombia
Completed
Cosultorio Privado Dr. ToledoBogotá, Colombia
Completed
KAT General Hospital of AthensKifisia, 14561, Greece
Completed
Fakultna nemocnica s poliklinikouBratislava, 826 06, Slovakia
Completed
Nemocnica s poliklinikou ZilinaZilina, 012 07, Slovakia
Completed
Nemocnica Kosice-SacaKosice - Saca, 040 15, Slovakia
Completed
Vilnius University Hospital of Emergency CareVilnius, LT-04130, Lithuania
Completed
Keski-Suomen keskussairaalaJyväskylä, 40620, Finland

Primary Outcome

  • Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes
    date_rangeTime Frame:
    Treatment period : up to day 36+/-6
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE)
    date_rangeTime Frame:
    Treatment period : up to day 36+/-6
    enhanced_encryption
    Safety Issue:
    no
  • Incidence of symptomatic VTE (DVT, PE)
    date_rangeTime Frame:
    Treatment period : up to day 36+/-6
    enhanced_encryption
    Safety Issue:
    no
  • Incidence of DVT (total, proximal, distal)
    date_rangeTime Frame:
    Treatment period : up to day 36+/-6
    enhanced_encryption
    Safety Issue:
    no
  • Incidence of symptomatic VTE during follow-up
    date_rangeTime Frame:
    Follow-up period: following 36+/-6 days
    enhanced_encryption
    Safety Issue:
    no
  • The composite endpoint comprising major VTE and treatment-emergent major bleeding
    date_rangeTime Frame:
    For major VTE, treatment period: up to Day 36+/-6 ; for major bleeding, from first dose of double-blind study medication to up to two days after last dose of double-blind study medication
    enhanced_encryption
    Safety Issue:
    no
  • Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death
    date_rangeTime Frame:
    Treatment period : up to day 36+/-6
    enhanced_encryption
    Safety Issue:
    no
  • Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related death
    date_rangeTime Frame:
    Treatment period : up to day 36+/-6
    enhanced_encryption
    Safety Issue:
    no
  • Treatment-emergent major bleedings
    date_rangeTime Frame:
    From first dose of double-blind study medication to up to two days after last dose of double-blind study medication
    enhanced_encryption
    Safety Issue:
    yes

Trial design

RECORD 1 Study: REgulation of Coagulation in ORthopedic Surgery to prevent DVT and PE, controlled, double-blind, randomized study of BAY 59-7939 in the extended prevention of VTE in patients undergoing elective total hip replacement
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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