check_circleStudy Completed

Venous Thromboembolism

Bayer Identifier:

11355

ClinicalTrials.gov Identifier:

NCT00362232

EudraCT Number:

2006-002402-60

EU CT Number:

Not Available
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.

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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Male and female patients aged 18 years or above
    - Patients scheduled for elective total knee replacement
  • - 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
3148
Trial Dates
June 2006 - January 2008
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Gill Orthopedic CenterLubbock, 79410, United States
Completed
Arizona Research Center, Inc.Phoenix, 85023, United States
Completed
Jacksonville Center for Clinical ResearchJacksonville, 32216, United States
Completed
West Alabama Research, Inc.Tuscaloosa, 35406, United States
Completed
Oklahoma City VA Medical CenterOklahoma City, 73162, United States
Completed
Center for Joint CareMissoula, 59802, United States
Completed
Capstone Clinical Trials, Inc.Birmingham, 35209, United States
Completed
Advanced Orthopedic & Sports Medicine SpecialistsDenver, 80230, United States
Completed
Scripps Center of Orthopaedic Research & EducationLa Jolla, 92037, United States
Completed
Harbor - UCLA Medical CenterTorrance, 90502-2004, United States
Completed
Southeastern Center for Clinical TrialsDecatur, 30033, United States
Completed
Lubbock Sports MedicineLubbock, 79410, United States
Completed
Presbyterian Hospital of DallasDallas, 75231, United States
Completed
Texas Center for Joint ReplacementPlano, 75093, United States
Completed
Capstone Clinical Trials, Inc.Birmingham, 35209, United States
Completed
Intermountain Research CenterBoise, 83702, United States
Completed
Holy Name Medical CenterTeaneck, 07666, United States
Completed
Charleston Orthopaedic AssociatesCharleston, 29414, United States
Completed
Teton Research, LLCLittle Rock, 72205, United States
Completed
Unlimited Research, LPSan Antonio, 78233, United States
Completed
Wellington Orthopaedic & Sports MedicineCincinnati, 45242, United States
Completed
Orthopedic Specialty ClinicSpokane, 99218, United States
Completed
Baptist Clinical ResearchPensacola, 32501, United States
Completed
Bone & Joint Clinic of HoustonHouston, 77030, United States
Completed
Research Alliance Inc.Clearwater, 33756, United States
Completed
Orthopaedic Associates of South BrowardHollywood, 33021, United States
Completed
Texas Orthopedic SpecialistsGrapevine, 76051, United States
Completed
Orthopaedic AssociatesTowson, 21204, United States
Completed
Visions Clinical ResearchBoynton Beach, 33472-2952, United States
Completed
Advent Clinical Research Centers, Inc.Pinellas Park, 33781, United States
Completed
Florida Orthopedic Associates, PADeLand, 32720, United States
Completed
Nautical Clinical ResearchMeridian, 83642, United States
Completed
Peak Orthopedics, PLLCCentennial, 80112, United States
Completed
CORE Orthopaedic Medical CenterEncinitas, 92024, United States
Completed
Sports Medicine and Orthopaedics CenterGreensboro, 27401, United States
Completed
Colorado Orthopaedic Consultants, PCEnglewood, 80110, United States
Completed
Office of Dr. Brian E. Gunnlaugson, MDJohnstown, 15901, United States
Completed
Shreenath Clinical ServicesFountain Valley, 92708, United States
Completed
Shreenath Clinical ServicesFountain Valley, 92708, United States
Completed
Sutter North Medical FoundationYuba City, 95991, United States
Completed
Southern California Orthopedic InstituteBakersfield, 93309, United States
Completed
Capstone Clinical Trials, Inc.Birmingham, 35209, United States
Completed
Szpital Kliniczny Dzieciatka Jezus -Centrum Leczenia ObrazenWarszawa, 02-005, Poland
Completed
Szpital Specjalistyczny im. Zeromskiego SPZOZKrakow, 31-913, Poland
Completed
University Orthopedics CenterState College, 16801, United States
Completed
Martin, Bowen & Hefley Knee and Sports MedicineLittle Rock, 72205, United States
Completed
California Physician's Research AllianceEncinitas, 92024, United States
Completed
San Antonio Medical AssociatesSan Antonio, 78205, United States
Completed
Shreenath Clinical ServicesFountain Valley, 92708, United States
Completed
Shreenath Clinical ServicesFountain Valley, 92708, United States
Completed
Wojewódzki Szpital ZespolonyKielce, Poland
Completed
Wojewodzki Szpital ZespolonyElblag, 82-300, Poland
Completed
Szpital Specjalistyczny Sw. LukaszaKonskie, 26-200, Poland
Completed
Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZLublin, 20-718, Poland
Completed
Wojewodzki Szpital Specjalistyczny im. M. KopernikaGdansk, 80-803, Poland
Completed
Office of Dr. Gordon Kruger, MDWoodstock, N4S 5B2, Canada
Completed
Brant Community Healthcare SystemBrantford, N3R 1G9, Canada
Completed
Dr. Everett Chalmers HospitalFredericton, E3B 5N5, Canada
Completed
Sir Mortimer B. Davis Jewish General HospitalMontreal, H3T 1E2, Canada
Completed
Szpital Uniwersytecki im. Antoniego JuraszaBydgoszcz, 85-094, Poland
Completed
CSK MSWiAWarszawa, 02-507, Poland
Completed
Wojewodzki Szpital Specjalistyczny nr 5Sosnowiec, 41-200, Poland
Completed
Montreal General HospitalMontreal, H3G 1A4, Canada
Completed
Queen Elizabeth HospitalCharlottetown, C1A 8T5, Canada
Completed
Scarbororgh Hospital-Grace DivisionScarborough, M1M 3W3, Canada
Completed
Thunder Bay Regional Health Sciences CentreThunder Bay, P7B 6V4, Canada
Completed
Rouge Valley Health SystemAjax, L1S 2J4, Canada
Completed
Lakeridge Health-OshawaOshawa, L1G 2B9, Canada
Completed
Ottawa Hospital - Civic CampusOttawa, K1Y 4E9, Canada
Completed
Hosp. de Especialidades C.M.N. Lic. Ignacio García TéllezMérida, 97150, Mexico
Completed
Hospital de Traumatologia y Ortopedia Lomas Verdes IMSSEdo. de Mexico, 53120, Mexico
Completed
Hospital General Regional No. 46 IMSSGuadalajara, 44350, Mexico
Completed
Hospital General Regional No. 45Guadalajara, 44200, Mexico
Completed
Hässleholms SjukhusHässleholm, 281 25, Sweden
Completed
Scarbororgh Hospital-General DivisionScarborough, M1P 2V5, Canada
Completed
Central Alberta ResearchRed Deer, T4N 6V7, Canada
Completed
Medical Arts Health Research GroupPenticton, V2A 5C8, Canada
Completed
Peterborough Regional Health CentrePeterborough, K9J 7C6, Canada
Completed
Office of Dr.Wayne Pisesky, MDKelowna, V1W 4V5, Canada
Completed
Office of Dr. Paul Zalzal, MDOakville, L6J 3M5, Canada
Completed
Medicor Research, Inc.Sudbury, P3A 1Y8, Canada
Completed
Hospital Regional ISSSTE MonterreyMonterrey, 64380, Mexico
Completed
Hospital Regional "Valentín Gómez Farías"Zapopan, 45100, Mexico
Completed
Hospital de Traumatologia y Ortopedia No 21 IMSSMonterrey, 64000, Mexico
Completed
SU/ÖstraGöteborg, 416 85, Sweden
Completed
Västerviks SjukhusVästervik, 593 81, Sweden
Completed
Växjö CentrallasarettVäxjö, 351 85, Sweden
Completed
Regionshospitalet SilkeborgSilkeborg, 8600, Denmark
Terminated
Sykehuset Innlandet HF LillehammerLillehammer, 2609, Norway
Terminated
Martina Hansens HospitalBaerum postterminal, 1306, Norway
Completed
Capio S:t Görans Sjukhus ABStockholm, 112 81, Sweden
Completed
Örebro UniversitetssjukhusÖrebro, 701 85, Sweden
Completed
Herlev HospitalHerlev, 2730, Denmark
Completed
Gentofte HospitalHellerup, DK-2900, Denmark
Completed
Hvidovre HospitalHvidovre, 2650, Denmark
Completed
Nordsjællands Hospital - HørsholmHørsholm, 2970, Denmark
Completed
Viborg SygehusViborg, 8800, Denmark
Terminated
Sykehuset Innlandet HF KongsvingerKongsvinger, 2212, Norway
Terminated
Sykehuset Innlandet HF GjøvikGjövik, 2819, Norway
Completed
Assaf Harofeh Medical CenterZerifin, 70300, Israel
Completed
Edith Wolfson Medical CenterHolon, 58100, Israel
Completed
Tel Aviv Sourasky Medical CenterTel Aviv, 64239, Israel
Completed
Military Medical AcademySofia, 1431, Bulgaria
Completed
MHATPleven, 5800, Bulgaria
Completed
Vilnius University Hospital of Emergency CareVilnius, LT-04130, Lithuania
Completed
Klaipeda University HospitalKlaipeda, 92288, Lithuania
Completed
Hip and Knee Clinic Fracture and Orthopaedic HospitalAhmedabad, 380006, India
Completed
Tel Aviv Sourasky Medical CenterTel Aviv, 64239, Israel
Completed
Meir Medical CenterKfar Saba, 44281, Israel
Completed
Soroka University Medical CenterBeer Sheva, 85025, Israel
Completed
Rabin Medical Center - Beilinson CampusPetach Tikva, 49100, Israel
Completed
UMHAT "Sveti Georgi"Plovdiv, 4002, Bulgaria
Completed
Kaunas Medical University HospitalKaunas, LT-50009, Lithuania
Completed
Kaunas Red Cross Clinical HospitalKaunas, 44320, Lithuania
Completed
Panevezys HospitalPanevezys, 35144, Lithuania
Completed
Krishna Institute of Medical Sciences Ltd.Secunderabad, 500 003, India
Completed
Dayanand Medical College& HospitalLudhiana, 141001, India
Completed
Centre for Knee SurgeryBaroda, 390007, India
Completed
Global HospitalsHyderabad, 500004, India
Completed
Deenanath Mangeshkar HospitalPune, 411009, India
Completed
St John's Medical College HospitalBangalore, 560034, India
Completed
Yashodha HospitalHyderabad, India
Completed
Jehangir HospitalPune, 411001, India
Completed
Shalby HospitalAhmedabad, 380054, India
Completed
All Inida Institute of Medical SciencesNew Delhi, 110029, India
Completed
Apollo HospitalChennai, 600 006, India
Completed
Yashodha HospitalSecundrabad, 500003, India
Completed
Victoria HospitalBangalore, 560001, India
Completed
National Medical CentreKarachi, Pakistan
Completed
O.M.I HospitalKarachi, Pakistan
Completed
Liaquat National HospitalKarachi, 74800, Pakistan
Completed
Sri Jayewardenepura General HospitalKotte, Sri Lanka
Completed
National Hospital of Sri LankaColombo-80, Sri Lanka
Completed
Colombo North Teaching HospitalRagama, Sri Lanka

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 population
    date_rangeTime Frame:
    Up to 16 days after surgery
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    Up to 16 days after surgery
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE) per protocol population of major VTE
    date_rangeTime Frame:
    Up to 16 days after surgery
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    Up to 16 days after surgery
    enhanced_encryption
    Safety Issue:
    No
  • Incidence of symptomatic VTE (DVT, PE) per protocol population.
    date_rangeTime Frame:
    Up to 16 days after surgery
    enhanced_encryption
    Safety Issue:
    No
  • Incidence of symptomatic VTE (DVT, PE) per modified intent to treat population.
    date_rangeTime Frame:
    Up to 16 days after surgery
    enhanced_encryption
    Safety Issue:
    No
  • Incidence of DVT (proximal, distal) per protocol population.
    date_rangeTime Frame:
    Up to 16 days after surgery
    enhanced_encryption
    Safety Issue:
    No
  • Incidence of DVT (proximal, distal) per modified intent to treat population.
    date_rangeTime Frame:
    Up to 16 days after surgery
    enhanced_encryption
    Safety Issue:
    No
  • Incidence of symptomatic VTE during follow-up per protocol population.
    date_rangeTime Frame:
    Up to 47 days after surgery
    enhanced_encryption
    Safety Issue:
    No
  • Incidence of symptomatic VTE during follow-up per modified intent to treat population.
    date_rangeTime Frame:
    Up to 47 days after surgery
    enhanced_encryption
    Safety Issue:
    No
  • The composite endpoint comprising major VTE and treatment-emergent major bleeding per subjects valid for analysis of net clinical benefit
    date_rangeTime Frame:
    Up to 47 days after surgery
    enhanced_encryption
    Safety Issue:
    No
  • Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death per protocol population.
    date_rangeTime Frame:
    Up to 16 days after surgery
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    Up to 16 days after surgery
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    Up to 16 days after surgery
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    Up to 16 days after surgery
    enhanced_encryption
    Safety Issue:
    No
  • Treatment-emergent major bleedings per safety population.
    date_rangeTime Frame:
    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).
    enhanced_encryption
    Safety Issue:
    Yes

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

Additional Information

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