FactOr XIa inhibiTion for the pRevention of venOus Thromboembolism in Patients Undergoing Total Knee Arthroplasty
NCT ID: NCT03276143
Last Updated: 2020-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
813 participants
INTERVENTIONAL
2017-09-21
2019-01-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Enoxaparin
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received enoxaparin for at least 10 days until venography was performed.
Enoxaparin
40 mg enoxaparin administered as subcutaneous injection once daily
Apixaban
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received apixaban for at least 10 days until venography was performed.
Apixaban
2.5 mg apixaban administered as tablet orally twice daily
BAY1213790 0.3 mg/kg (post-surgery)
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.3 mg BAY1213790 once post-surgery.
BAY1213790
Single dose of BAY1213790 administered as intravenous infusion
BAY1213790 0.6 mg/kg (post-surgery)
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.6 mg BAY1213790 once post-surgery.
BAY1213790
Single dose of BAY1213790 administered as intravenous infusion
BAY1213790 1.2 mg/kg (post-surgery)
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.2 mg BAY1213790 once post-surgery.
BAY1213790
Single dose of BAY1213790 administered as intravenous infusion
BAY1213790 1.8 mg/kg (post-surgery)
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.8 mg BAY1213790 once post-surgery.
BAY1213790
Single dose of BAY1213790 administered as intravenous infusion
BAY1213790 0.3 mg/kg (pre-surgery)
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.3 mg BAY1213790 once pre-surgery.
BAY1213790
Single dose of BAY1213790 administered as intravenous infusion
BAY1213790 1.8 mg/kg (pre-surgery)
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.8 mg BAY1213790 once pre-surgery.
BAY1213790
Single dose of BAY1213790 administered as intravenous infusion
Interventions
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Enoxaparin
40 mg enoxaparin administered as subcutaneous injection once daily
Apixaban
2.5 mg apixaban administered as tablet orally twice daily
BAY1213790
Single dose of BAY1213790 administered as intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Women of non-childbearing potential
Exclusion Criteria
* Prior deep vein thrombosis
* Body weight above 135 kg
* Creatinine clearance below 60 ml/min
* Recent (\<6 months) myocardial infarction or ischemic stroke
* Contraindication listed in the local label of the comparator treatments
* Requirement for full dose anticoagulation or dual antiplatelet therapy
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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UMHAT Sveti Georgi
Plovdiv, , Bulgaria
Acibadem City Clinic Multiprofile Hospital for Active Treatm
Sofia, , Bulgaria
UMHAT Tsaritsa Joanna-ISUL EAD Sofia
Sofia, , Bulgaria
Medical Investigative & Clinical Evaluation Inc.
Windsor, Ontario, Canada
Fakultni nemocnice u sv. Anny
Brno, , Czechia
Nemocnice Ceske Budejovice, a.s.
České Budějovice, , Czechia
Okresni nemocnice Jindrichuv Hradec
Jindřichův Hradec, , Czechia
Regional Hospital Pardubice
Pardubice, , Czechia
KAT General Hospital of Athens
Kifissia, , Greece
Konstantopoulio General Hospital of Nea Ionia - Agia Olga
Nea Ionia, , Greece
University General Hospital of Patras
Pátrai, , Greece
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, , Greece
Rambam Health Corporation
Haifa, , Israel
Lady Davis Carmel Medical Center
Haifa, , Israel
Meir Medical Center
Kfar Saba, , Israel
Clalit Health Services through Rabin Medical Center - Beilinson Campus
Petah Tikva, , Israel
Kaplan Medical Center
Rehovot, , Israel
Liepaja Regional Hospital
Liepāja, , Latvia
Riga 2nd City Hospital
Riga, , Latvia
Hospital of Traumatology and Orthopaedics
Riga, , Latvia
Valmiera Hospital
Valmiera, , Latvia
Kaunas clinical hospital (Laisves ave.)
Kaunas, , Lithuania
Lithuanian university of Health science
Kaunas, , Lithuania
PI Klaipedos University Hospital
Klaipėda, , Lithuania
Republican Vilnius University Hospital
Vilnius, , Lithuania
Vilnius University Hospital Santaros Klinikos
Vilnius, , Lithuania
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, , Poland
Wojewódzki Szpital Zespolony
Kielce, , Poland
Szpital Specjalistyczny im. Rydygiera
Krakow, , Poland
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
Lodz, , Poland
Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZ
Lublin, , Poland
Uniwersytecki Szpital Kliniczny UM we Wroclawiu
Wroclaw, , Poland
Hospital de Cascais
Alcabideche, Lisbon District, Portugal
CHS - Hospital Ortopedico Sant Iago do Outao
Setúbal, Setúbal District, Portugal
CHBV - Hospital Infante D. Pedro
Aveiro, , Portugal
CHL - Hospital Santo Andre
Leiria, , Portugal
ULSAM - Hospital Santa Luzia
Viana do Castelo, , Portugal
Russian Scientific Center n.a. acad. G.A. Ilizarov
Kurgan, , Russia
Privolzhskiy Federal Medical Research Center
Nizhny Novgorod, , Russia
City Hospital #2
Saint Petersburg, , Russia
Sci-Res. Institute of Traumatology and Orthopaedia
Saint Petersburg, , Russia
Clinical Hospital for Emergency Care n.a. N.V.Solovyov
Yaroslavl, , Russia
Pretoria Academic Hospital New
Pretoria, Gauteng, South Africa
UCT Clinical Research Centre
Cape Town, Western Cape, South Africa
Clinical Projects Research SA
Worcester, Western Cape, South Africa
Ciutat Sanitària i Universitària de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Fundación Hospital Alcorcón
Alcorcón, Madrid, Spain
Ciutat Sanitària i Universitaria de la Vall d'Hebron
Barcelona, , Spain
Hospital Clínic i Provincial de Barcelona
Barcelona, , Spain
Complejo Hospitalario de Jaén
Jaén, , Spain
Hospital Clínico Universitario San Carlos
Madrid, , Spain
Cherkasy Reg Clinical Hospital of Cherkasy Reg Council
Cherkasy, , Ukraine
Ivano-Frankivsk Regional Clinical Hospital
Ivano-Frankivsk, , Ukraine
Kyiv Regional Clinical Hospital
Kyiv, , Ukraine
Countries
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References
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Weitz JI, Bauersachs R, Becker B, Berkowitz SD, Freitas MCS, Lassen MR, Metzig C, Raskob GE. Effect of Osocimab in Preventing Venous Thromboembolism Among Patients Undergoing Knee Arthroplasty: The FOXTROT Randomized Clinical Trial. JAMA. 2020 Jan 14;323(2):130-139. doi: 10.1001/jama.2019.20687.
Related Links
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Click here to find results for studies related to Bayer products
Other Identifiers
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2016-002681-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17664
Identifier Type: -
Identifier Source: org_study_id
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