Clinical trial NCT03276143: FactOr XIa inhibiTion for the pRevention of venOus Thromboembolism in Patients Undergoing Total Knee Arthroplasty
Official title: A Randomized, Active-comparator-controlled, Multicenter Study to Assess the Safety and Efficacy of Different Doses of BAY1213790 for the Prevention of Venous Thromboembolism in Patients Undergoing Elective Primary Total Knee Arthroplasty, Open-label to Treatment and Observer-blinded to BAY1213790 Doses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Knee Arthroplasty, Total
Keywords: Orthopedic surgery
Venous thromboembolism
Deep vein thrombosis (DVT)
Anticoagulation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-09-08
Enrollment: 813
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was to compare the study drug BAY1213790 to existing therapies, i.e. enoxaparin or apixaban, for the prevention of blood clotting and safety in patients undergoing total knee arthroplasty (TKA). The study was open-label, but observer-blinded for the different doses of BAY1213790. This means that it was known which treatment was given, but it was not known which dose of BAY1213790 was administered.


Eligibility criteria: Inclusion Criteria:

* Patients aged ≥18 years and undergoing elective primary, unilateral Total Knee Arthroplasty (TKA)
* Women of non-childbearing potential

Exclusion Criteria:

* High risk for clinically significant bleeding
* 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

Primary outcomes:
measure: 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 excluded
timeFrame: Up to 15 days
measure: Incidence of composite endpoint of major and clinically relevant non-major bleeding
timeFrame: Up to 15 days
Secondary outcomes:
measure: Incidence of composite endpoint of symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded up to Day 157 or objectively confirmed asymptomatic DVT up to Day 15
timeFrame: Up to 157 days
measure: Incidence of composite endpoint of major and clinically relevant non-major bleeding
timeFrame: Up to 157 days
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
facility: UMHAT Sveti Georgi
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Multiprofile Hospital for Active Treatm
city: Sofia
country: Bulgaria
facility: UMHAT Tsaritsa Joanna-ISUL EAD Sofia
city: Windsor
country: Canada
facility: Medical Investigative & Clinical Evaluation Inc.
state: Ontario
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny
city: Ceske Budejovice
country: Czechia
facility: Nemocnice Ceske Budejovice, a.s.
city: Jindrichuv Hradec
country: Czechia
facility: Okresni nemocnice Jindrichuv Hradec
city: Pardubice
country: Czechia
facility: Regional Hospital Pardubice
city: Kifisia
country: Greece
facility: KAT General Hospital of Athens
city: Nea Ionia
country: Greece
facility: Konstantopoulio General Hospital of Nea Ionia - Agia Olga
city: Patras
country: Greece
facility: University General Hospital of Patras
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital of Thessaloniki
city: Haifa
country: Israel
facility: Rambam Health Corporation
city: Haifa
country: Israel
facility: Lady Davis Carmel Medical Center
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
city: Petah Tikva
country: Israel
facility: Clalit Health Services through Rabin Medical Center - Beilinson Campus
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Liepaja
country: Latvia
facility: Liepaja Regional Hospital
city: Riga
country: Latvia
facility: Riga 2nd City Hospital
city: Riga
country: Latvia
facility: Hospital of Traumatology and Orthopaedics
city: Valmiera
country: Latvia
facility: Valmiera Hospital
city: Kaunas
country: Lithuania
facility: Kaunas clinical hospital (Laisves ave.)
city: Kaunas
country: Lithuania
facility: Lithuanian university of Health science
city: Klaipeda
country: Lithuania
facility: PI Klaipedos University Hospital
city: Vilnius
country: Lithuania
facility: Republican Vilnius University Hospital
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
city: Kielce
country: Poland
facility: Wojewódzki Szpital Zespolony
city: Krakow
country: Poland
facility: Szpital Specjalistyczny im. Rydygiera
city: Lodz
country: Poland
facility: Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
city: Lublin
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZ
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny UM we Wroclawiu
city: Alcabideche
country: Portugal
facility: Hospital de Cascais
state: Lisboa
city: Setubal
country: Portugal
facility: CHS - Hospital Ortopedico Sant Iago do Outao
state: Setúbal
city: Aveiro
country: Portugal
facility: CHBV - Hospital Infante D. Pedro
city: Leiria
country: Portugal
facility: CHL - Hospital Santo Andre
city: Viana do Castelo
country: Portugal
facility: ULSAM - Hospital Santa Luzia
city: Kurgan
country: Russian Federation
facility: Russian Scientific Center n.a. acad. G.A. Ilizarov
city: Nizhny Novgorod
country: Russian Federation
facility: Privolzhskiy Federal Medical Research Center
city: St. Petersburg
country: Russian Federation
facility: City Hospital #2
city: St. Petersburg
country: Russian Federation
facility: Sci-Res. Institute of Traumatology and Orthopaedia
city: Yaroslavl
country: Russian Federation
facility: Clinical Hospital for Emergency Care n.a. N.V.Solovyov
city: Pretoria
country: South Africa
facility: Pretoria Academic Hospital New
state: Gauteng
city: Cape Town
country: South Africa
facility: UCT Clinical Research Centre
state: Western Cape
city: Worcester
country: South Africa
facility: Clinical Projects Research SA
state: Western Cape
city: L'Hospitalet de Llobregat
country: Spain
facility: Ciutat Sanitària i Universitària de Bellvitge
state: Barcelona
city: Alcorcón
country: Spain
facility: Fundación Hospital Alcorcón
state: Madrid
city: Barcelona
country: Spain
facility: Ciutat Sanitària i Universitaria de la Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial de Barcelona
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
city: Madrid
country: Spain
facility: Hospital Clínico Universitario San Carlos
city: Cherkasy
country: Ukraine
facility: Cherkasy Reg Clinical Hospital of Cherkasy Reg Council
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Regional Clinical Hospital
city: Kyiv
country: Ukraine
facility: Kyiv Regional Clinical Hospital
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.