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)
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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