Trial Condition(s):
Venous Thromboembolism
Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism (DVT) and Pulmonary Embolism (PE). A study of BAY59-7939 in the prevention of Venous Thrombo Embolism (VTE) in subjects undergoing elective total knee replacement. (RECORD 4)
Bayer Identifier:
11355
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
The purpose of this study is to assess if 10 mg BAY59-7939, taken once daily as a tablet, is safe and prevents blood clot which may form after a knee replacement operation.
Inclusion Criteria
- Male and female patients aged 18 years or above - Patients scheduled for elective total knee replacement
Exclusion Criteria
- Active bleeding or high risk of bleeding contraindicating treatment with Low Molecular Weight Heparin (LMWH) - Contraindication listed in the labeling or conditions precluding subject treatment with enoxaparin or requiring dose adjustment (e.g. severe renal impairment, please refer to the local label of enoxaparin in your country) - Conditions prohibiting bilateral venography (e.g. amputation of 1 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 | |
|---|---|
Locations Gill Orthopedic Center Lubbock, United States, 79410 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Arizona Research Center, Inc. Phoenix, United States, 85023 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Jacksonville Center for Clinical Research Jacksonville, United States, 32216 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations West Alabama Research, Inc. Tuscaloosa, United States, 35406 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oklahoma City VA Medical Center Oklahoma City, United States, 73162 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Center for Joint Care Missoula, United States, 59802 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Capstone Clinical Trials, Inc. Birmingham, United States, 35209 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Advanced Orthopedic & Sports Medicine Specialists Denver, United States, 80230 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Scripps Center of Orthopaedic Research & Education La Jolla, United States, 92037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Harbor - UCLA Medical Center Torrance, United States, 90502-2004 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Southeastern Center for Clinical Trials Decatur, United States, 30033 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lubbock Sports Medicine Lubbock, United States, 79410 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Presbyterian Hospital of Dallas Dallas, United States, 75231 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Texas Center for Joint Replacement Plano, United States, 75093 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Intermountain Research Center Boise, United States, 83702 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Holy Name Medical Center Teaneck, United States, 07666 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Charleston Orthopaedic Associates Charleston, United States, 29414 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Teton Research, LLC Little Rock, United States, 72205 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Unlimited Research, LP San Antonio, United States, 78233 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wellington Orthopaedic & Sports Medicine Cincinnati, United States, 45242 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Orthopedic Specialty Clinic Spokane, United States, 99218 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Baptist Clinical Research Pensacola, United States, 32501 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bone & Joint Clinic of Houston Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Research Alliance Inc. Clearwater, United States, 33756 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Orthopaedic Associates of South Broward Hollywood, United States, 33021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Texas Orthopedic Specialists Grapevine, United States, 76051 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Orthopaedic Associates Towson, United States, 21204 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Visions Clinical Research Boynton Beach, United States, 33472-2952 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Advent Clinical Research Centers, Inc. Pinellas Park, United States, 33781 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Florida Orthopedic Associates, PA DeLand, United States, 32720 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nautical Clinical Research Meridian, United States, 83642 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Peak Orthopedics, PLLC Centennial, United States, 80112 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CORE Orthopaedic Medical Center Encinitas, United States, 92024 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sports Medicine and Orthopaedics Center Greensboro, United States, 27401 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Colorado Orthopaedic Consultants, PC Englewood, United States, 80110 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Brian E. Gunnlaugson, MD Johnstown, United States, 15901 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shreenath Clinical Services Fountain Valley, United States, 92708 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sutter North Medical Foundation Yuba City, United States, 95991 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Southern California Orthopedic Institute Bakersfield, United States, 93309 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpital Kliniczny Dzieciatka Jezus -Centrum Leczenia Obrazen Warszawa, Poland, 02-005 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpital Specjalistyczny im. Zeromskiego SPZOZ Krakow, Poland, 31-913 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University Orthopedics Center State College, United States, 16801 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Martin, Bowen & Hefley Knee and Sports Medicine Little Rock, United States, 72205 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations California Physician's Research Alliance Encinitas, United States, 92024 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations San Antonio Medical Associates San Antonio, United States, 78205 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojewódzki Szpital Zespolony Kielce, Poland | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojewodzki Szpital Zespolony Elblag, Poland, 82-300 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpital Specjalistyczny Sw. Lukasza Konskie, Poland, 26-200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZ Lublin, Poland, 20-718 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojewodzki Szpital Specjalistyczny im. M. Kopernika Gdansk, Poland, 80-803 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Gordon Kruger, MD Woodstock, Canada, N4S 5B2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Brant Community Healthcare System Brantford, Canada, N3R 1G9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Everett Chalmers Hospital Fredericton, Canada, E3B 5N5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sir Mortimer B. Davis Jewish General Hospital Montreal, Canada, H3T 1E2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpital Uniwersytecki im. Antoniego Jurasza Bydgoszcz, Poland, 85-094 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CSK MSWiA Warszawa, Poland, 02-507 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojewodzki Szpital Specjalistyczny nr 5 Sosnowiec, Poland, 41-200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Montreal General Hospital Montreal, Canada, H3G 1A4 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen Elizabeth Hospital Charlottetown, Canada, C1A 8T5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Scarbororgh Hospital-Grace Division Scarborough, Canada, M1M 3W3 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Thunder Bay Regional Health Sciences Centre Thunder Bay, Canada, P7B 6V4 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rouge Valley Health System Ajax, Canada, L1S 2J4 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lakeridge Health-Oshawa Oshawa, Canada, L1G 2B9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ottawa Hospital - Civic Campus Ottawa, Canada, K1Y 4E9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hosp. de Especialidades C.M.N. Lic. Ignacio García Téllez Mérida, Mexico, 97150 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital de Traumatologia y Ortopedia Lomas Verdes IMSS Edo. de Mexico, Mexico, 53120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital General Regional No. 46 IMSS Guadalajara, Mexico, 44350 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital General Regional No. 45 Guadalajara, Mexico, 44200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hässleholms Sjukhus Hässleholm, Sweden, 281 25 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Scarbororgh Hospital-General Division Scarborough, Canada, M1P 2V5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Central Alberta Research Red Deer, Canada, T4N 6V7 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Arts Health Research Group Penticton, Canada, V2A 5C8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Peterborough Regional Health Centre Peterborough, Canada, K9J 7C6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr.Wayne Pisesky, MD Kelowna, Canada, V1W 4V5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Paul Zalzal, MD Oakville, Canada, L6J 3M5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medicor Research, Inc. Sudbury, Canada, P3A 1Y8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Regional ISSSTE Monterrey Monterrey, Mexico, 64380 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Regional "Valentín Gómez Farías" Zapopan, Mexico, 45100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital de Traumatologia y Ortopedia No 21 IMSS Monterrey, Mexico, 64000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SU/Östra Göteborg, Sweden, 416 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Västerviks Sjukhus Västervik, Sweden, 593 81 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Växjö Centrallasarett Växjö, Sweden, 351 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Regionshospitalet Silkeborg Silkeborg, Denmark, 8600 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sykehuset Innlandet HF Lillehammer Lillehammer, Norway, 2609 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Martina Hansens Hospital Baerum postterminal, Norway, 1306 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Capio S:t Görans Sjukhus AB Stockholm, Sweden, 112 81 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Örebro Universitetssjukhus Örebro, Sweden, 701 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Herlev Hospital Herlev, Denmark, 2730 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gentofte Hospital Hellerup, Denmark, DK-2900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hvidovre Hospital Hvidovre, Denmark, 2650 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nordsjællands Hospital - Hørsholm Hørsholm, Denmark, 2970 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Viborg Sygehus Viborg, Denmark, 8800 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sykehuset Innlandet HF Kongsvinger Kongsvinger, Norway, 2212 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sykehuset Innlandet HF Gjøvik Gjövik, Norway, 2819 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Assaf Harofeh Medical Center Zerifin, Israel, 70300 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Edith Wolfson Medical Center Holon, Israel, 58100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tel Aviv Sourasky Medical Center Tel Aviv, Israel, 64239 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Military Medical Academy Sofia, Bulgaria, 1431 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations MHAT Pleven, Bulgaria, 5800 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vilnius University Hospital of Emergency Care Vilnius, Lithuania, LT-04130 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klaipeda University Hospital Klaipeda, Lithuania, 92288 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hip and Knee Clinic Fracture and Orthopaedic Hospital Ahmedabad, India, 380006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Meir Medical Center Kfar Saba, Israel, 44281 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Soroka University Medical Center Beer Sheva, Israel, 85025 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rabin Medical Center - Beilinson Campus Petach Tikva, Israel, 49100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UMHAT "Sveti Georgi" Plovdiv, Bulgaria, 4002 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kaunas Medical University Hospital Kaunas, Lithuania, LT-50009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kaunas Red Cross Clinical Hospital Kaunas, Lithuania, 44320 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Panevezys Hospital Panevezys, Lithuania, 35144 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Krishna Institute of Medical Sciences Ltd. Secunderabad, India, 500 003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dayanand Medical College& Hospital Ludhiana, India, 141001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre for Knee Surgery Baroda, India, 390007 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Global Hospitals Hyderabad, India, 500004 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Deenanath Mangeshkar Hospital Pune, India, 411009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St John's Medical College Hospital Bangalore, India, 560034 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yashodha Hospital Hyderabad, India | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Jehangir Hospital Pune, India, 411001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shalby Hospital Ahmedabad, India, 380054 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations All Inida Institute of Medical Sciences New Delhi, India, 110029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Apollo Hospital Chennai, India, 600 006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yashodha Hospital Secundrabad, India, 500003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Victoria Hospital Bangalore, India, 560001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Medical Centre Karachi, Pakistan | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations O.M.I Hospital Karachi, Pakistan | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Liaquat National Hospital Karachi, Pakistan, 74800 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sri Jayewardenepura General Hospital Kotte, Sri Lanka | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Hospital of Sri Lanka Colombo-80, Sri Lanka | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Colombo North Teaching Hospital Ragama, Sri Lanka | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
RECORD 4 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE; a controlled, double-blind, randomized study of BAY59-7939 in the prevention of VTE in subjects undergoing elective total knee replacement
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Composite endpoint of total Venous Thrombo Embolism (VTE) i.e.: Any Deep Vein Thromboembolism (DVT) (proximal and/or distal), Non fatal Pulmonary Embolism (PE), Death of all causes per protocol populationTimeframe: Up to 16 days after surgery
- Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes per modified intent to treat population.Timeframe: Up to 16 days after surgery
Secondary Outcome
- Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE) per protocol population of major VTETimeframe: Up to 16 days after surgery
- Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE) per modified intent to treat population of major VTE.Timeframe: Up to 16 days after surgery
- Incidence of symptomatic VTE (DVT, PE) per protocol population.Timeframe: Up to 16 days after surgery
- Incidence of symptomatic VTE (DVT, PE) per modified intent to treat population.Timeframe: Up to 16 days after surgery
- Incidence of DVT (proximal, distal) per protocol population.Timeframe: Up to 16 days after surgery
- Incidence of DVT (proximal, distal) per modified intent to treat population.Timeframe: Up to 16 days after surgery
- Incidence of symptomatic VTE during follow-up per protocol population.Timeframe: Up to 47 days after surgery
- Incidence of symptomatic VTE during follow-up per modified intent to treat population.Timeframe: Up to 47 days after surgery
- The composite endpoint comprising major VTE and treatment-emergent major bleeding per subjects valid for analysis of net clinical benefitTimeframe: Up to 47 days after surgery
- Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death per protocol population.Timeframe: Up to 16 days after surgery
- Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death per modified intent to treat population.Timeframe: Up to 16 days after surgery
- Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related death per protocol of major VTE population.Timeframe: Up to 16 days after surgery
- Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related death per modified intent to treat of major VTE population.Timeframe: Up to 16 days after surgery
- Treatment-emergent major bleedings per safety population.Timeframe: from start of double-blind study medication to last dose of double-blind study medication plus two days. The average duration of double-blind treatment was 12 days in each treatment group (safety population).
Additional Information
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