FactOr XIa inhibiTion for the pRevention of venOus Thromboembolism in Patients Undergoing Total Knee Arthroplasty

Knee Arthroplasty, Total Clinical Trial

— FOXTROT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03276143
• Other study ID #: 17664
• Secondary ID: 2016-002681-31
• Status: Completed
• Phase: Phase 2
• Start date: September 21, 2017
• Est. completion date: January 2, 2019

Study information

• Verified date: February 2020
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 813
• Est. completion date: January 2, 2019
• Est. primary completion date: August 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Arthroplasty, Total
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Bulgaria	UMHAT Sveti Georgi	Plovdiv
Bulgaria	Acibadem City Clinic Multiprofile Hospital for Active Treatm	Sofia
Bulgaria	UMHAT Tsaritsa Joanna-ISUL EAD Sofia	Sofia
Canada	Medical Investigative & Clinical Evaluation Inc.	Windsor	Ontario
Czechia	Fakultni nemocnice u sv. Anny	Brno
Czechia	Nemocnice Ceske Budejovice, a.s.	Ceske Budejovice
Czechia	Okresni nemocnice Jindrichuv Hradec	Jindrichuv Hradec
Czechia	Regional Hospital Pardubice	Pardubice
Greece	KAT General Hospital of Athens	Kifisia
Greece	Konstantopoulio General Hospital of Nea Ionia - Agia Olga	Nea Ionia
Greece	University General Hospital of Patras	Patras
Greece	Papageorgiou General Hospital of Thessaloniki	Thessaloniki
Israel	Lady Davis Carmel Medical Center	Haifa
Israel	Rambam Health Corporation	Haifa
Israel	Meir Medical Center	Kfar-Saba
Israel	Clalit Health Services through Rabin Medical Center - Beilinson Campus	Petah Tikva
Israel	Kaplan Medical Center	Rehovot
Latvia	Liepaja Regional Hospital	Liepaja
Latvia	Hospital of Traumatology and Orthopaedics	Riga
Latvia	Riga 2nd City Hospital	Riga
Latvia	Valmiera Hospital	Valmiera
Lithuania	Kaunas clinical hospital (Laisves ave.)	Kaunas
Lithuania	Lithuanian university of Health science	Kaunas
Lithuania	PI Klaipedos University Hospital	Klaipeda
Lithuania	Republican Vilnius University Hospital	Vilnius
Lithuania	Vilnius University Hospital Santaros Klinikos	Vilnius
Poland	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
Portugal	Hospital de Cascais	Alcabideche	Lisboa
Portugal	CHBV - Hospital Infante D. Pedro	Aveiro
Portugal	CHL - Hospital Santo Andre	Leiria
Portugal	CHS - Hospital Ortopedico Sant Iago do Outao	Setubal	Setúbal
Portugal	ULSAM - Hospital Santa Luzia	Viana do Castelo
Russian Federation	Russian Scientific Center n.a. acad. G.A. Ilizarov	Kurgan
Russian Federation	Privolzhskiy Federal Medical Research Center	Nizhny Novgorod
Russian Federation	City Hospital #2	St. Petersburg
Russian Federation	Sci-Res. Institute of Traumatology and Orthopaedia	St. Petersburg
Russian Federation	Clinical Hospital for Emergency Care n.a. N.V.Solovyov	Yaroslavl
South Africa	UCT Clinical Research Centre	Cape Town	Western Cape
South Africa	Pretoria Academic Hospital New	Pretoria	Gauteng
South Africa	Clinical Projects Research SA	Worcester	Western Cape
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	Ciutat Sanitària i Universitària de Bellvitge	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Clínico Universitario San Carlos	Madrid
Ukraine	Cherkasy Reg Clinical Hospital of Cherkasy Reg Council	Cherkasy
Ukraine	Ivano-Frankivsk Regional Clinical Hospital	Ivano-Frankivsk
Ukraine	Kyiv Regional Clinical Hospital	Kyiv

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Bulgaria,  Canada,  Czechia,  Greece,  Israel,  Latvia,  Lithuania,  Poland,  Portugal,  Russian Federation,  South Africa,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	DVT - Deep vein thrombosis / PE - Pulmonary embolism All suspected events were reviewed and classified by the Central Independent Adjudication Committee.	Up to 15 days
Primary	Incidence of composite endpoint of major and clinically relevant non-major bleeding	All suspected events were reviewed and classified by the Central Independent Adjudication Committee.	Up to 15 days
Secondary	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	All suspected events were reviewed and classified by the Central Independent Adjudication Committee.	Up to 157 days
Secondary	Incidence of composite endpoint of major and clinically relevant non-major bleeding	All suspected events were reviewed and classified by the Central Independent Adjudication Committee.	Up to 157 days

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