Trial Condition(s):
Prevention, Venous Thromboembolism
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 (RECORD 2)
Bayer Identifier:
11357
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
Inclusion Criteria
- Male and female patients aged 18 years or above - Patients scheduled for elective total hip replacement
Exclusion Criteria
- 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Kings College Hospital London, United Kingdom, SE5 9RS | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dumfries & Galloway Royal Infirmary Dumfries, United Kingdom, DG1 4EP | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chesterfield Royal Hospital Chesterfield, United Kingdom, S44 5BL | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oklahoma Thrombosis Research Group Oklahoma City, United States, 73103 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bay Pines VA Healthcare System Bay Pines, United States, 33744 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Miami Institute for Medical Research Miami, United States, 33186 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Capstone Clinical Trials, Inc. Birmingham, United States, 35205 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Parma Parma, Italy, 43100 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Ospedale di Lecco Lecco, Italy, 23900 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. San Martino Genova, Italy, 16132 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ottawa Hospital-General Campus Ottawa, Canada, K1H 8L6 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Red Deer Regional Hospital Red Deer, Canada, T4N 4E7 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hotel Dieu-Grace Hospital Windsor, Canada, N9A 1E1 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Thunder Bay Regional Health Sciences Centre Thunder Bay, Canada, P7B 6V4 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Arts Health Research Group Penticton, Canada, V2A 5C8 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Victoria Hospital Kirkcaldy, United Kingdom, KY2 5AH | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations James Paget Hospital Great Yarmouth, United Kingdom, NR31 6LA | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Epsom General Hospital Epsom, United Kingdom, KT18 7EG | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Northampton General Hospital Northampton, United Kingdom, NN1 5BD | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Broadgreen Hospital Liverpool, United Kingdom, L14 3LB | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations JCP Medical Research Denver, United States, 80222 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Modena Policlinico Modena, Italy, 41100 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Santa Maria Misericordia UD Udine, Italy, 33100 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Senese Siena, Italy, 53100 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Federico II Napoli, Italy, 80131 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lakeridge Health-Oshawa Oshawa, Canada, L1G 2B9 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ottawa Hospital - Civic Campus Ottawa, Canada, K1Y 4E9 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. John Regional Hospital St. John, Canada, E2L 4L2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Grace General Hospital Winnipeg, Canada, R3J 3M7 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Scarbororgh Hospital-General Division Scarborough, Canada, M1P 2V5 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitetssjukhuset Örebro, Sweden, 701 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kungälvs Sjukhus Kungälv, Sweden, 442 83 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Skaraborgs Sjukhus Falköping Falköping, Sweden, 521 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Capio S:t Görans Sjukhus AB Stockholm, Sweden, 112 81 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hässleholms Sjukhus Hässleholm, Sweden, 281 25 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sjukhuset i Varberg Varberg, Sweden, 432 81 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Holbaek Sygehus Holbaek, Denmark, 4300 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Viborg Sygehus Viborg, Denmark, 8800 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hvidovre Hospital Hvidovre, Denmark, 2650 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations H:S Bispebjerg Hospital Copenhagen, Denmark, 2400 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Herlev Hospital Herlev, Denmark, 2730 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Witwatersrand Johannesburg, South Africa, 2132 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Olivedale Hospital Randburg, South Africa, 2125 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Stellenbosch Cape Town, South Africa, 7505 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal North Shore Hospital Sydney, Australia, 2065 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Eastern Clinical Research Unit - Box Hill Melbourne, Australia, 3128 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Curry Cabral Lisboa, Portugal, 1069-166 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Scarbororgh Hospital-Grace Division Scarborough, Canada, M1M 3W3 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde" Guadalajara, Mexico, 44280 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínica del Parque Chihuahua, Chih., Mexico, 31000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Länssjukhuset Sundsvall-Härnösand Sundsvall, Sweden, 851 86 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Växjö Centrallasarett Växjö, Sweden, 351 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Skaraborgs Sjukhus Lidköping Lidköping, Sweden, 531 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations H:S Amager Hospital Copenhagen, Denmark, 2300 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Amtssygehuset i Glostrup Glostrup, Denmark, 2600 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Regionshospitalet Silkeborg Silkeborg, Denmark, 8600 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations H:S Frederiksberg Hospital Frederiksberg, Denmark, 2000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sykehuset Innlandet HF Tynset Tynset, Norway, 2501 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Helse Nord-Tönderlag HF sykehuset Namsos Namsos, Norway, 7800 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Omnia Røde Kors Klinikk AS Oslo, Norway, 0264 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sykehuset Innlandet HF Kongsvinger Kongsvinger, Norway, 2212 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lovisenberg Diakonale sykehus Oslo, Norway, 0440 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Private Practice Dr UK Dhanjee Newcastle, South Africa, 2940 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of the Free State Bloemfontein, South Africa, 9300 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Canberra Hospital Canberra, Australia, 2605 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lismore Base Hospital LISMORE, Australia, 2480 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gold Coast Hospital Southport, Australia, 4215 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Geelong Hospital Geelong, Australia, 3220 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations H.Sant¿lago do Outão Setúbal, Portugal, 299-182 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Hospitalar de Torres Vedras Torres Vedras, Portugal, 2560-324 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital de São João Porto, Portugal, 4200-319 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario de la Samaritana Bogotá, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Médico Imbanaco Cali, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario Pedro Ernesto Rio de Janeiro, Brazil | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Madre Tereza Belo Horizonte, Brazil, 30380 090 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CE Serv. Cirurg. e Reabilitação Ortopédico-Traumalogica Batatais, Brazil, 14300 000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitário Cajuru da PUC PR Curitiba, Brazil, 80050-350 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Ipiranga Sao Paulo, Brazil, 04262-000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations PS Fraturas Centro de Estudos Ortopédicos de Passo Fundo Passo Fundo, Brazil, 99010-100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations General Hospital of People's Libration Army Beijing, China, 100853 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Peking University Jishuitan Hospital Beijing, China, 100035 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Jinan Qianfoshan Hospital Jinan, China, 250014 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Changhai Hospital of Second Military Medical University Shanghai, China, 200433 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr Soetomo Hospital Surabaya, Indonesia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asan Medical Center Seoul, South Korea, 138-736 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hanyang University Guri Hospital Kyunggido, South Korea, 471710 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Siauliai County Hospital Siauliai, Lithuania, 76231 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klaipeda University Hospital Klaipeda, Lithuania, 92288 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tartu University Hospital Tartu, Estonia, 51014 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Guillermo Almenara Lima, Peru, LIMA 1 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Edgardo Rebagliati Martins Lima, Peru, LIMA 11 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Médico Naval Callao, Peru, CALLAO 2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Dos de Mayo Lima, Peru, 01 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Horpital of Traumathology and Orthopedics Riga, Latvia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Riga 2nd City Hospital Riga, Latvia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Central Hospital of Liepaja Liepaja, Latvia, 3402 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fundacio del Caribe para la Investigacio Bio-Medica (BIOS) Barranquilla, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clínica Medellín Medellín, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Investigación Clínica FOQUS Bogotá, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Inst. de Previdência do Servidor do Estado de Minas Gerais Belo Horizonte, Brazil, 30170-132 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Irmandade da Santa Casa de Misericordia - Sao Paulo Sao Paulo, Brazil, 0122-1020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Irmandade Santa Casa de Misericórdia de Marília Marília, Brazil, 17515-900 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UNIFESP/EPM Sao Paulo, Brazil, 04023-900 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Peking University People's Hospital Beijing, China, 100044 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The 6th People's Hospital of Shanghai Jiao Tong University Shanghai, China, 200233 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rui Jin Hospital, Shanghai Second Medical University Shanghai, China, 200025 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Zhongshan Hospital Fudan University. Shanghai, China, 200032 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The affili. hospital of medical college Qingdao University Qingdao, China, 266003 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations First Affiliated Hospital of Guangzhou University of TCM Guangzhou,, China, 510405 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Second Affiliated Hospital Xian Jiaotong University School Xi'an, China, 710004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr Hasan Sadikin Hospital Bandung, Indonesia, 40161 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Samsung Medical Center Seoul, South Korea, 135-710 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kyungpook National University Hospital Daegu, South Korea, 700721 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kaunas Red Cross Clinical Hospital Kaunas, Lithuania, 44320 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Panevezys Hospital Panevezys, Lithuania, 35144 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dayanand Medical College& Hospital Ludhiana, India, 141001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St John's Medical College Hospital Bangalore, India, 560034 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CARE Hospital Hyderabad, India, 500034 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yashodha Hospital Secundrabad, India, 500003 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Victoria Hospital Bangalore, India, 560001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations KEM hospital Mumbai, India, 400012 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chang Gung Memorial Hospital Kaohsiung Kaohsiung, Taiwan, China, 833 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chang-Guang Memorial Hospital Taoyuan, Taiwan, China, 333 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations East Tallinn Central Hospital Tallinn, Estonia, 10138 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Alberto Sabogal Callao, Peru, CALLAO 2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Nacional Cayetano Heredia Lima, Peru, 31 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Nacional Arzobispo Loayza Lima Cercado, Peru, LIMA 1 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations North Shore Hospital Auckland, New Zealand, 0622 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Thrombosis Unit Auckland, New Zealand, 1023 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causesTimeframe: Treatment period: up to day 35+/-6
Secondary Outcome
- Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE)Timeframe: Treatment period: up to day 35+/-6
- Incidence of symptomatic VTE (DVT, PE)Timeframe: Treatment period: up to day 35+/-6
- Incidence of DVT (total, proximal, distal)Timeframe: Treatment period: up to day 35+/-6
- Incidence of symptomatic VTE during follow-upTimeframe: Follow-up period: following 35+/-6 days
- The composite endpoint comprising major VTE and treatment-emergent major bleedingTimeframe: 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
- Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all deathTimeframe: Treatment period: up to day 35+/-6
- Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related deathTimeframe: Treatment period: up to day 35+/-6
- Treatment-emergent major bleedingsTimeframe: From first dose of double-blind study medication to up to two days after last dose of double-blind study medication
Additional Information
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