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 | Status | |
|---|---|---|
Locations Gill Orthopedic Center Lubbock, United States, 79410 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Arizona Research Center, Inc. Phoenix, United States, 85023 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Jacksonville Center for Clinical Research Jacksonville, United States, 32216 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations West Alabama Research, Inc. Tuscaloosa, United States, 35406 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oklahoma City VA Medical Center Oklahoma City, United States, 73162 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Center for Joint Care Missoula, United States, 59802 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Capstone Clinical Trials, Inc. Birmingham, United States, 35209 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Advanced Orthopedic & Sports Medicine Specialists Denver, United States, 80230 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Scripps Center of Orthopaedic Research & Education La Jolla, United States, 92037 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Harbor - UCLA Medical Center Torrance, United States, 90502-2004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Southeastern Center for Clinical Trials Decatur, United States, 30033 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lubbock Sports Medicine Lubbock, United States, 79410 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Presbyterian Hospital of Dallas Dallas, United States, 75231 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Texas Center for Joint Replacement Plano, United States, 75093 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Intermountain Research Center Boise, United States, 83702 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Holy Name Medical Center Teaneck, United States, 07666 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Charleston Orthopaedic Associates Charleston, United States, 29414 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Teton Research, LLC Little Rock, United States, 72205 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Unlimited Research, LP San Antonio, United States, 78233 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wellington Orthopaedic & Sports Medicine Cincinnati, United States, 45242 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Orthopedic Specialty Clinic Spokane, United States, 99218 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Baptist Clinical Research Pensacola, United States, 32501 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bone & Joint Clinic of Houston Houston, United States, 77030 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Research Alliance Inc. Clearwater, United States, 33756 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Orthopaedic Associates of South Broward Hollywood, United States, 33021 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Texas Orthopedic Specialists Grapevine, United States, 76051 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Orthopaedic Associates Towson, United States, 21204 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Visions Clinical Research Boynton Beach, United States, 33472-2952 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Advent Clinical Research Centers, Inc. Pinellas Park, United States, 33781 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Florida Orthopedic Associates, PA DeLand, United States, 32720 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nautical Clinical Research Meridian, United States, 83642 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Peak Orthopedics, PLLC Centennial, United States, 80112 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CORE Orthopaedic Medical Center Encinitas, United States, 92024 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sports Medicine and Orthopaedics Center Greensboro, United States, 27401 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Colorado Orthopaedic Consultants, PC Englewood, United States, 80110 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Brian E. Gunnlaugson, MD Johnstown, United States, 15901 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shreenath Clinical Services Fountain Valley, United States, 92708 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sutter North Medical Foundation Yuba City, United States, 95991 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Southern California Orthopedic Institute Bakersfield, United States, 93309 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpital Kliniczny Dzieciatka Jezus -Centrum Leczenia Obrazen Warszawa, Poland, 02-005 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpital Specjalistyczny im. Zeromskiego SPZOZ Krakow, Poland, 31-913 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University Orthopedics Center State College, United States, 16801 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Martin, Bowen & Hefley Knee and Sports Medicine Little Rock, United States, 72205 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations California Physician's Research Alliance Encinitas, United States, 92024 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations San Antonio Medical Associates San Antonio, United States, 78205 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojewódzki Szpital Zespolony Kielce, Poland | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojewodzki Szpital Zespolony Elblag, Poland, 82-300 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpital Specjalistyczny Sw. Lukasza Konskie, Poland, 26-200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZ Lublin, Poland, 20-718 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojewodzki Szpital Specjalistyczny im. M. Kopernika Gdansk, Poland, 80-803 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Gordon Kruger, MD Woodstock, Canada, N4S 5B2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Brant Community Healthcare System Brantford, Canada, N3R 1G9 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Everett Chalmers Hospital Fredericton, Canada, E3B 5N5 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sir Mortimer B. Davis Jewish General Hospital Montreal, Canada, H3T 1E2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpital Uniwersytecki im. Antoniego Jurasza Bydgoszcz, Poland, 85-094 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CSK MSWiA Warszawa, Poland, 02-507 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojewodzki Szpital Specjalistyczny nr 5 Sosnowiec, Poland, 41-200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Montreal General Hospital Montreal, Canada, H3G 1A4 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen Elizabeth Hospital Charlottetown, Canada, C1A 8T5 | 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 Thunder Bay Regional Health Sciences Centre Thunder Bay, Canada, P7B 6V4 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rouge Valley Health System Ajax, Canada, L1S 2J4 | Status Completed | 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 Hosp. de Especialidades C.M.N. Lic. Ignacio García Téllez Mérida, Mexico, 97150 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital de Traumatologia y Ortopedia Lomas Verdes IMSS Edo. de Mexico, Mexico, 53120 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital General Regional No. 46 IMSS Guadalajara, Mexico, 44350 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital General Regional No. 45 Guadalajara, Mexico, 44200 | 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 Scarbororgh Hospital-General Division Scarborough, Canada, M1P 2V5 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Central Alberta Research Red Deer, Canada, T4N 6V7 | 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 Peterborough Regional Health Centre Peterborough, Canada, K9J 7C6 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr.Wayne Pisesky, MD Kelowna, Canada, V1W 4V5 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Paul Zalzal, MD Oakville, Canada, L6J 3M5 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medicor Research, Inc. Sudbury, Canada, P3A 1Y8 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Regional ISSSTE Monterrey Monterrey, Mexico, 64380 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Regional "Valentín Gómez Farías" Zapopan, Mexico, 45100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital de Traumatologia y Ortopedia No 21 IMSS Monterrey, Mexico, 64000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SU/Östra Göteborg, Sweden, 416 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Västerviks Sjukhus Västervik, Sweden, 593 81 | 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 Regionshospitalet Silkeborg Silkeborg, Denmark, 8600 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sykehuset Innlandet HF Lillehammer Lillehammer, Norway, 2609 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Martina Hansens Hospital Baerum postterminal, Norway, 1306 | Status Terminated | 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 Örebro Universitetssjukhus Örebro, Sweden, 701 85 | 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 Gentofte Hospital Hellerup, Denmark, DK-2900 | 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 Nordsjællands Hospital - Hørsholm Hørsholm, Denmark, 2970 | 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 Sykehuset Innlandet HF Kongsvinger Kongsvinger, Norway, 2212 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sykehuset Innlandet HF Gjøvik Gjövik, Norway, 2819 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Assaf Harofeh Medical Center Zerifin, Israel, 70300 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Edith Wolfson Medical Center Holon, Israel, 58100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tel Aviv Sourasky Medical Center Tel Aviv, Israel, 64239 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Military Medical Academy Sofia, Bulgaria, 1431 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations MHAT Pleven, Bulgaria, 5800 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vilnius University Hospital of Emergency Care Vilnius, Lithuania, LT-04130 | 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 Hip and Knee Clinic Fracture and Orthopaedic Hospital Ahmedabad, India, 380006 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Meir Medical Center Kfar Saba, Israel, 44281 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Soroka University Medical Center Beer Sheva, Israel, 85025 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rabin Medical Center - Beilinson Campus Petach Tikva, Israel, 49100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UMHAT "Sveti Georgi" Plovdiv, Bulgaria, 4002 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kaunas Medical University Hospital Kaunas, Lithuania, LT-50009 | 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 Krishna Institute of Medical Sciences Ltd. Secunderabad, India, 500 003 | 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 Centre for Knee Surgery Baroda, India, 390007 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Global Hospitals Hyderabad, India, 500004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Deenanath Mangeshkar Hospital Pune, India, 411009 | 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 Yashodha Hospital Hyderabad, India | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Jehangir Hospital Pune, India, 411001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shalby Hospital Ahmedabad, India, 380054 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations All Inida Institute of Medical Sciences New Delhi, India, 110029 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Apollo Hospital Chennai, India, 600 006 | 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 National Medical Centre Karachi, Pakistan | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations O.M.I Hospital Karachi, Pakistan | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Liaquat National Hospital Karachi, Pakistan, 74800 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sri Jayewardenepura General Hospital Kotte, Sri Lanka | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Hospital of Sri Lanka Colombo-80, Sri Lanka | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Colombo North Teaching Hospital Ragama, Sri Lanka | Status Completed | 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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