check_circleStudy Completed
Knee Arthroplasty, Total
Bayer Identifier:
17664
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
FactOr XIa inhibiTion for the pRevention of venOus Thromboembolism in patients undergoing total knee arthroplasty
Trial purpose
This study is to compare the study drug BAY1213790 to existing therapies, ie Enoxaparin or Apixaban for the prevention of blood clotting and safety in patients undergoing total knee arthroplasty (TKA). The study is open-label, but observer-blind for the different doses of BAY1213790 administered. This means that it is known which treatment is given, but it is not known which dose of BAY1213790 is administered.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
791Trial Dates
September 2017 - January 2019Phase
Phase 2Could I Receive a placebo
NoProducts
BAY1213790Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Konstantopoulio General Hospital of Nea Ionia - Agia Olga | Nea Ionia, 14233, Greece |
Completed | KAT General Hospital of Athens | Kifisia, 14561, Greece |
Completed | KAT General Hospital of Athens | Kifisia, 14561, Greece |
Completed | Papageorgiou General Hospital of Thessaloniki | Thessaloniki, 56403, Greece |
Completed | UMHAT Sveti Georgi | Plovdiv, 4002, Bulgaria |
Withdrawn | UMHATEM N. I. Pirogov EAD | Sofia, 1606, Bulgaria |
Completed | Acibadem City Clinic Multiprofile Hospital for Active Treatm | Sofia, 1407, Bulgaria |
Completed | UMHAT Tsaritsa Joanna-ISUL EAD Sofia | Sofia, 1527, Bulgaria |
Completed | Lithuanian university of Health science | Kaunas, LT-50009, Lithuania |
Completed | Kaunas clinical hospital (Laisves ave.) | Kaunas, LT-44320, Lithuania |
Completed | Vilnius University Hospital Santaros Klinikos | Vilnius, LT-08661, Lithuania |
Completed | Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok, 15-276, Poland |
Completed | Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi | Lodz, 92-213, Poland |
Completed | Wojewodzki Szpital Specjalistyczny im. Rydygiera | Krakow, 31-826, Poland |
Completed | Uniwersytecki Szpital Kliniczny UM we Wroclawiu | Wroclaw, 50-556, Poland |
Completed | Wojewódzki Szpital Zespolony | Kielce, Poland |
Completed | Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZ | Lublin, 20-718, Poland |
Completed | Nemocnice Ceske Budejovice, a.s. | Ceske Budejovice, 370 87, Czech Republic |
Withdrawn | Nemocnice Nove Mesto na Morave | Nove Mesto na Morave, 592 31, Czech Republic |
Completed | Regional Hospital Pardubice | Pardubice, 530 03, Czech Republic |
Completed | Okresni nemocnice Jindrichuv Hradec | Jindrichuv Hradec, 377 38, Czech Republic |
Completed | Rambam Health Corporation | Haifa, 3109601, Israel |
Completed | Clalit Health Services through Rabin Medical Center - Beilinson Campus | Petah Tikva, 4941492, Israel |
Completed | Meir Medical Center | Kfar-Saba, 4428164, Israel |
Completed | Kaplan Medical Center | Rehovot, 7610001, Israel |
Completed | Lady Davis Carmel Medical Center | Haifa, 3436212, Israel |
Completed | Ciutat Sanitària i Universitaria de la Vall d'Hebron | Barcelona, 08035, Spain |
Completed | Hospital Clínico Universitario San Carlos | Madrid, 28040, Spain |
Completed | Hospital Clínic i Provincial de Barcelona | Barcelona, 08036, Spain |
Completed | Fundación Hospital Alcorcón | Alcorcón, 28922, Spain |
Completed | Ciutat Sanitària i Universitària de Bellvitge | L'Hospitalet de Llobregat, 08907, Spain |
Completed | Clinical Projects Research SA | Worcester, 6850, South Africa |
Completed | UCT Clinical Research Centre | Cape Town, South Africa |
Withdrawn | TREAD Research cc | Cape Town, 7500, South Africa |
Completed | Pretoria Academic Hospital New | Pretoria, 0084, South Africa |
Withdrawn | Fakultni nemocnice Brno | Brno, 625 00, Czech Republic |
Completed | Kyiv Regional Clinical Hospital | Kyiv, 4107, Ukraine |
Completed | Cherkasy Reg Clinical Hospital of Cherkasy Reg Council | Cherkasy, 18009, Ukraine |
Completed | Ivano-Frankivsk Regional Clinical Hospital | Ivano-Frankivsk, 76008, Ukraine |
Withdrawn | Hopital Jean Talon | Montreal, H2E 1S6, Canada |
Completed | Medical Investigative & Clinical Evaluation Inc. | Windsor, N8W 1E6, Canada |
Completed | Valmiera Hospital | Valmiera, LV-4201, Latvia |
Completed | Privolzhskiy Federal Medical Research Center | Nizhny Novgorod, 603155, Russia |
Completed | Russian Scientific Center n.a. acad. G.A. Ilizarov | Kurgan, 640014, Russia |
Completed | Clinical Hospital for Emergency Care n.a. N.V.Solovyov | Yaroslavl, 150003, Russia |
Completed | Liepaja Regional Hospital | Liepaja, LV-3414, Latvia |
Completed | Riga 2nd City Hospital | Riga, LV-1004, Latvia |
Completed | Hospital of Traumatology and Orthopaedics | Riga, LV–1005, Latvia |
Completed | Sci-Res. Institute of Traumatology and Orthopaedia | St. Petersburg, 195427, Russia |
Completed | City Hospital #2 | St. Petersburg, 194354, Russia |
Withdrawn | Clinical Hospital #122 n.a. L.G. Sokolov | St. Petersburg, 194291, Russia |
Completed | University General Hospital of Patras | Rio / Patras, 265 04, Greece |
Completed | PI Klaipedos University Hospital | Klaipeda, LT-92288, Lithuania |
Completed | Republican Vilnius University Hospital | Vilnius, LT-04130, Lithuania |
Completed | CHS - Hospital Ortopedico Sant Iago do Outao | Setubal, 2900-182, Portugal |
Completed | CHBV - Hospital Infante D. Pedro | Aveiro, 3810-501, Portugal |
Completed | Hospital de Cascais | Alcabideche, 2755-009, Portugal |
Completed | CHL - Hospital Santo Andre | Leiria, 2410-197, Portugal |
Completed | Complejo Hospitalario de Jaén | Jaén, 23009, Spain |
Withdrawn | UMHAT Kanev AD | Ruse, 7002, Bulgaria |
Completed | ULSAM - Hospital Santa Luzia | Viana do Castelo, 4901-858, Portugal |
Withdrawn | Fakultni Nemocnice Hradec Kralove | Hradec Kralove, 500 05, Czech Republic |
Completed | Fakultni nemocnice u sv. Anny | Brno, 656 91, Czech Republic |
Primary Outcome
- Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral venography, objectively confirmed symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excludedDVT: deep vein thrombosis PE: pulmonary embolism All suspected events will be reviewed and classified by the Central Independent Adjudication Committeedate_rangeTime Frame:up to Visit 7 (Day 12+3)
- Incidence of composite endpoint of major and clinically relevant non-major bleedingAll suspected events will be reviewed and classified by the Central Independent Adjudication Committeedate_rangeTime Frame:up to Visit 7 (Day 12+3)
Secondary Outcome
- Incidence of composite endpoint of symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded up to Day 150 or objectively confirmed asymptomatic DVT up to day 12All suspected events will be reviewed and classified by the Central Independent Adjudication Committeedate_rangeTime Frame:up to Visit 10 (Day 150±7)
- Incidence of composite endpoint of major and clinically relevant non-major bleedingAll suspected events will be reviewed and classified by the Central Independent Adjudication Committeedate_rangeTime Frame:up to Visit 10 (Day 150±7)
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
PreventionAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
3