check_circleStudy Completed

Prevention, Venous thromboembolism

Bayer Identifier:

11357

ClinicalTrials.gov Identifier:

NCT00332020

EudraCT Number:

2005-004691-20

EU CT Number:

Not Available
Regulation of Coagulation in Orthopedic Surgery to prevent DVT and PE, a controlled, double-blind, randomized study of BAY 59-7939 in the extended prevention of VTE in patients undergoing elective total hip replacement

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 can help prevent blood clots forming after a 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
2457
Trial Dates
February 2006 - June 2007
Phase
Phase 3
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Kings College HospitalLondon, SE5 9RS, United Kingdom
Completed
Dumfries & Galloway Royal InfirmaryDumfries, DG1 4EP, United Kingdom
Completed
Chesterfield Royal HospitalChesterfield, S44 5BL, United Kingdom
Completed
Oklahoma Thrombosis Research GroupOklahoma City, 73103, United States
Completed
Bay Pines VA Healthcare SystemBay Pines, 33744, United States
Completed
Miami Institute for Medical ResearchMiami, 33186, United States
Completed
Capstone Clinical Trials, Inc.Birmingham, 35205, United States
Not yet recruiting
A.O.U. di ParmaParma, 43100, Italy
Not yet recruiting
A.O. Ospedale di LeccoLecco, 23900, Italy
Not yet recruiting
A.O.U. San MartinoGenova, 16132, Italy
Completed
Ottawa Hospital-General CampusOttawa, K1H 8L6, Canada
Completed
Red Deer Regional HospitalRed Deer, T4N 4E7, Canada
Completed
Hotel Dieu-Grace HospitalWindsor, N9A 1E1, Canada
Completed
Thunder Bay Regional Health Sciences CentreThunder Bay, P7B 6V4, Canada
Completed
Medical Arts Health Research GroupPenticton, V2A 5C8, Canada
Completed
Victoria HospitalKirkcaldy, KY2 5AH, United Kingdom
Completed
James Paget HospitalGreat Yarmouth, NR31 6LA, United Kingdom
Completed
Epsom General HospitalEpsom, KT18 7EG, United Kingdom
Completed
Northampton General HospitalNorthampton, NN1 5BD, United Kingdom
Completed
Broadgreen HospitalLiverpool, L14 3LB, United Kingdom
Completed
JCP Medical ResearchDenver, 80222, United States
Not yet recruiting
A.O.U. di Modena PoliclinicoModena, 41100, Italy
Not yet recruiting
A.O.U. Santa Maria Misericordia UDUdine, 33100, Italy
Not yet recruiting
A.O.U. SeneseSiena, 53100, Italy
Not yet recruiting
A.O.U. Federico IINapoli, 80131, Italy
Completed
Lakeridge Health-OshawaOshawa, L1G 2B9, Canada
Completed
Ottawa Hospital - Civic CampusOttawa, K1Y 4E9, Canada
Completed
St. John Regional HospitalSt. John, E2L 4L2, Canada
Completed
Grace General HospitalWinnipeg, R3J 3M7, Canada
Completed
Scarbororgh Hospital-General DivisionScarborough, M1P 2V5, Canada
Completed
UniversitetssjukhusetÖrebro, 701 85, Sweden
Completed
Kungälvs SjukhusKungälv, 442 83, Sweden
Completed
Skaraborgs Sjukhus FalköpingFalköping, 521 85, Sweden
Completed
Capio S:t Görans Sjukhus ABStockholm, 112 81, Sweden
Completed
Hässleholms SjukhusHässleholm, 281 25, Sweden
Completed
Sjukhuset i VarbergVarberg, 432 81, Sweden
Completed
Holbaek SygehusHolbaek, 4300, Denmark
Completed
Viborg SygehusViborg, 8800, Denmark
Completed
Hvidovre HospitalHvidovre, 2650, Denmark
Completed
H:S Bispebjerg HospitalCopenhagen, 2400, Denmark
Completed
Herlev HospitalHerlev, 2730, Denmark
Completed
University of WitwatersrandJohannesburg, 2132, South Africa
Completed
Olivedale HospitalRandburg, 2125, South Africa
Completed
University of StellenboschCape Town, 7505, South Africa
Completed
Royal North Shore HospitalSydney, 2065, Australia
Completed
Eastern Clinical Research Unit - Box HillMelbourne, 3128, Australia
Completed
Hospital Curry CabralLisboa, 1069-166, Portugal
Completed
Scarbororgh Hospital-Grace DivisionScarborough, M1M 3W3, Canada
Completed
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"Guadalajara, 44280, Mexico
Completed
Hospital Clínica del ParqueChihuahua, Chih., 31000, Mexico
Completed
Länssjukhuset Sundsvall-HärnösandSundsvall, 851 86, Sweden
Completed
Växjö CentrallasarettVäxjö, 351 85, Sweden
Completed
Skaraborgs Sjukhus LidköpingLidköping, 531 85, Sweden
Completed
H:S Amager HospitalCopenhagen, 2300, Denmark
Completed
Amtssygehuset i GlostrupGlostrup, 2600, Denmark
Completed
Regionshospitalet SilkeborgSilkeborg, 8600, Denmark
Completed
H:S Frederiksberg HospitalFrederiksberg, 2000, Denmark
Completed
Sykehuset Innlandet HF TynsetTynset, 2501, Norway
Completed
Helse Nord-Tönderlag HF sykehuset NamsosNamsos, 7800, Norway
Completed
Omnia Røde Kors Klinikk ASOslo, 0264, Norway
Completed
Sykehuset Innlandet HF KongsvingerKongsvinger, 2212, Norway
Completed
Lovisenberg Diakonale sykehusOslo, 0440, Norway
Completed
Private Practice Dr UK DhanjeeNewcastle, 2940, South Africa
Completed
University of the Free StateBloemfontein, 9300, South Africa
Completed
The Canberra HospitalCanberra, 2605, Australia
Completed
Lismore Base HospitalLISMORE, 2480, Australia
Completed
Gold Coast HospitalSouthport, 4215, Australia
Completed
Geelong HospitalGeelong, 3220, Australia
Completed
H.Sant¿lago do OutãoSetúbal, 299-182, Portugal
Completed
Centro Hospitalar de Torres VedrasTorres Vedras, 2560-324, Portugal
Completed
Hospital de São JoãoPorto, 4200-319, Portugal
Completed
Hospital Universitario de la SamaritanaBogotá, Colombia
Completed
Centro Médico ImbanacoCali, Colombia
Completed
Hospital Universitario Pedro ErnestoRio de Janeiro, Brazil
Completed
Hospital Madre TerezaBelo Horizonte, 30380 090, Brazil
Completed
CE Serv. Cirurg. e Reabilitação Ortopédico-TraumalogicaBatatais, 14300 000, Brazil
Completed
Hospital Universitário Cajuru da PUC PRCuritiba, 80050-350, Brazil
Completed
Hospital IpirangaSao Paulo, 04262-000, Brazil
Completed
PS Fraturas Centro de Estudos Ortopédicos de Passo FundoPasso Fundo, 99010-100, Brazil
Completed
General Hospital of People's Libration ArmyBeijing, 100853, China
Completed
Peking University Jishuitan HospitalBeijing, 100035, China
Completed
Jinan Qianfoshan HospitalJinan, 250014, China
Completed
Changhai Hospital of Second Military Medical UniversityShanghai, 200433, China
Completed
Dr Soetomo HospitalSurabaya, Indonesia
Completed
Asan Medical CenterSeoul, 138-736, Korea, Republic Of
Completed
Hanyang University Guri HospitalKyunggido, 471710, Korea, Republic Of
Completed
Siauliai County HospitalSiauliai, 76231, Lithuania
Completed
Klaipeda University HospitalKlaipeda, 92288, Lithuania
Completed
Tartu University HospitalTartu, 51014, Estonia
Completed
Hospital Guillermo AlmenaraLima, LIMA 1, Peru
Completed
Hospital Edgardo Rebagliati MartinsLima, LIMA 11, Peru
Completed
Centro Médico NavalCallao, CALLAO 2, Peru
Completed
Hospital Dos de MayoLima, 01, Peru
Completed
Horpital of Traumathology and OrthopedicsRiga, Latvia
Completed
Riga 2nd City HospitalRiga, Latvia
Completed
Central Hospital of LiepajaLiepaja, 3402, Latvia
Completed
Fundacio del Caribe para la Investigacio Bio-Medica (BIOS)Barranquilla, Colombia
Completed
Clínica MedellínMedellín, Colombia
Completed
Centro de Investigación Clínica FOQUSBogotá, Colombia
Completed
Inst. de Previdência do Servidor do Estado de Minas GeraisBelo Horizonte, 30170-132, Brazil
Completed
Irmandade da Santa Casa de Misericordia - Sao PauloSao Paulo, 0122-1020, Brazil
Completed
Irmandade Santa Casa de Misericórdia de MaríliaMarília, 17515-900, Brazil
Completed
UNIFESP/EPMSao Paulo, 04023-900, Brazil
Completed
Peking University People's HospitalBeijing, 100044, China
Completed
The 6th People's Hospital of Shanghai Jiao Tong UniversityShanghai, 200233, China
Completed
Rui Jin Hospital, Shanghai Second Medical UniversityShanghai, 200025, China
Completed
Zhongshan Hospital Fudan University.Shanghai, 200032, China
Completed
The affili. hospital of medical college Qingdao UniversityQingdao, 266003, China
Completed
First Affiliated Hospital of Guangzhou University of TCMGuangzhou,, 510405, China
Completed
Second Affiliated Hospital Xian Jiaotong University SchoolXi'an, 710004, China
Completed
Dr Hasan Sadikin HospitalBandung, 40161, Indonesia
Completed
Samsung Medical CenterSeoul, 135-710, Korea, Republic Of
Completed
Kyungpook National University HospitalDaegu, 700721, Korea, Republic Of
Completed
Kaunas Red Cross Clinical HospitalKaunas, 44320, Lithuania
Completed
Panevezys HospitalPanevezys, 35144, Lithuania
Completed
Dayanand Medical College& HospitalLudhiana, 141001, India
Completed
St John's Medical College HospitalBangalore, 560034, India
Completed
CARE HospitalHyderabad, 500034, India
Completed
Yashodha HospitalSecundrabad, 500003, India
Completed
Victoria HospitalBangalore, 560001, India
Completed
KEM hospitalMumbai, 400012, India
Not yet recruiting
Chang Gung Memorial Hospital KaohsiungKaohsiung, 833, Taiwan
Not yet recruiting
Chang-Guang Memorial HospitalTaoyuan, 333, Taiwan
Completed
East Tallinn Central HospitalTallinn, 10138, Estonia
Completed
Hospital Alberto SabogalCallao, CALLAO 2, Peru
Completed
Hospital Nacional Cayetano HerediaLima, 31, Peru
Completed
Hospital Nacional Arzobispo LoayzaLima Cercado, LIMA 1, Peru
Completed
North Shore HospitalAuckland, 0622, New Zealand
Completed
Thrombosis UnitAuckland, 1023, New Zealand

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 35+/-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 35+/-6
    enhanced_encryption
    Safety Issue:
    no
  • Incidence of symptomatic VTE (DVT, PE)
    date_rangeTime Frame:
    Treatment period: up to day 35+/-6
    enhanced_encryption
    Safety Issue:
    no
  • Incidence of DVT (total, proximal, distal)
    date_rangeTime Frame:
    Treatment period: up to day 35+/-6
    enhanced_encryption
    Safety Issue:
    no
  • Incidence of symptomatic VTE during follow-up
    date_rangeTime Frame:
    Follow-up period: following 35+/-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 35+/-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 35+/-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 35+/-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 2 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 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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