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

Primary Purpose

Knee Arthroplasty, Total

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Enoxaparin
Apixaban
BAY1213790
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Knee Arthroplasty, Total focused on measuring Orthopedic surgery, Venous thromboembolism, Deep vein thrombosis (DVT), Anticoagulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UMHAT Sveti Georgi
  • Acibadem City Clinic Multiprofile Hospital for Active Treatm
  • UMHAT Tsaritsa Joanna-ISUL EAD Sofia
  • Medical Investigative & Clinical Evaluation Inc.
  • Fakultni nemocnice u sv. Anny
  • Nemocnice Ceske Budejovice, a.s.
  • Okresni nemocnice Jindrichuv Hradec
  • Regional Hospital Pardubice
  • KAT General Hospital of Athens
  • Konstantopoulio General Hospital of Nea Ionia - Agia Olga
  • University General Hospital of Patras
  • Papageorgiou General Hospital of Thessaloniki
  • Rambam Health Corporation
  • Lady Davis Carmel Medical Center
  • Meir Medical Center
  • Clalit Health Services through Rabin Medical Center - Beilinson Campus
  • Kaplan Medical Center
  • Liepaja Regional Hospital
  • Riga 2nd City Hospital
  • Hospital of Traumatology and Orthopaedics
  • Valmiera Hospital
  • Kaunas clinical hospital (Laisves ave.)
  • Lithuanian university of Health science
  • PI Klaipedos University Hospital
  • Republican Vilnius University Hospital
  • Vilnius University Hospital Santaros Klinikos
  • Uniwersytecki Szpital Kliniczny w Bialymstoku
  • Wojewódzki Szpital Zespolony
  • Szpital Specjalistyczny im. Rydygiera
  • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
  • Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZ
  • Uniwersytecki Szpital Kliniczny UM we Wroclawiu
  • Hospital de Cascais
  • CHS - Hospital Ortopedico Sant Iago do Outao
  • CHBV - Hospital Infante D. Pedro
  • CHL - Hospital Santo Andre
  • ULSAM - Hospital Santa Luzia
  • Russian Scientific Center n.a. acad. G.A. Ilizarov
  • Privolzhskiy Federal Medical Research Center
  • City Hospital #2
  • Sci-Res. Institute of Traumatology and Orthopaedia
  • Clinical Hospital for Emergency Care n.a. N.V.Solovyov
  • Pretoria Academic Hospital New
  • UCT Clinical Research Centre
  • Clinical Projects Research SA
  • Ciutat Sanitària i Universitària de Bellvitge
  • Fundación Hospital Alcorcón
  • Ciutat Sanitària i Universitaria de la Vall d'Hebron
  • Hospital Clínic i Provincial de Barcelona
  • Complejo Hospitalario de Jaén
  • Hospital Clínico Universitario San Carlos
  • Cherkasy Reg Clinical Hospital of Cherkasy Reg Council
  • Ivano-Frankivsk Regional Clinical Hospital
  • Kyiv Regional Clinical Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Enoxaparin

Apixaban

BAY1213790 0.3 mg/kg (post-surgery)

BAY1213790 0.6 mg/kg (post-surgery)

BAY1213790 1.2 mg/kg (post-surgery)

BAY1213790 1.8 mg/kg (post-surgery)

BAY1213790 0.3 mg/kg (pre-surgery)

BAY1213790 1.8 mg/kg (pre-surgery)

Arm Description

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received enoxaparin for at least 10 days until venography was performed.

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received apixaban for at least 10 days until venography was performed.

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.3 mg BAY1213790 once post-surgery.

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.6 mg BAY1213790 once post-surgery.

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.2 mg BAY1213790 once post-surgery.

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.8 mg BAY1213790 once post-surgery.

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.3 mg BAY1213790 once pre-surgery.

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.8 mg BAY1213790 once pre-surgery.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 7, 2017
Last Updated
February 28, 2020
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT03276143
Brief Title
FactOr XIa inhibiTion for the pRevention of venOus Thromboembolism in Patients Undergoing Total Knee Arthroplasty
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 21, 2017 (Actual)
Primary Completion Date
August 20, 2018 (Actual)
Study Completion Date
January 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthroplasty, Total
Keywords
Orthopedic surgery, Venous thromboembolism, Deep vein thrombosis (DVT), Anticoagulation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
813 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enoxaparin
Arm Type
Active Comparator
Arm Description
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received enoxaparin for at least 10 days until venography was performed.
Arm Title
Apixaban
Arm Type
Active Comparator
Arm Description
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received apixaban for at least 10 days until venography was performed.
Arm Title
BAY1213790 0.3 mg/kg (post-surgery)
Arm Type
Experimental
Arm Description
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.3 mg BAY1213790 once post-surgery.
Arm Title
BAY1213790 0.6 mg/kg (post-surgery)
Arm Type
Experimental
Arm Description
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.6 mg BAY1213790 once post-surgery.
Arm Title
BAY1213790 1.2 mg/kg (post-surgery)
Arm Type
Experimental
Arm Description
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.2 mg BAY1213790 once post-surgery.
Arm Title
BAY1213790 1.8 mg/kg (post-surgery)
Arm Type
Experimental
Arm Description
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.8 mg BAY1213790 once post-surgery.
Arm Title
BAY1213790 0.3 mg/kg (pre-surgery)
Arm Type
Experimental
Arm Description
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.3 mg BAY1213790 once pre-surgery.
Arm Title
BAY1213790 1.8 mg/kg (pre-surgery)
Arm Type
Experimental
Arm Description
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.8 mg BAY1213790 once pre-surgery.
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Intervention Description
40 mg enoxaparin administered as subcutaneous injection once daily
Intervention Type
Drug
Intervention Name(s)
Apixaban
Intervention Description
2.5 mg apixaban administered as tablet orally twice daily
Intervention Type
Drug
Intervention Name(s)
BAY1213790
Other Intervention Name(s)
Osocimab
Intervention Description
Single dose of BAY1213790 administered as intravenous infusion
Primary Outcome Measure Information:
Title
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
Description
DVT - Deep vein thrombosis / PE - Pulmonary embolism All suspected events were reviewed and classified by the Central Independent Adjudication Committee.
Time Frame
Up to 15 days
Title
Incidence of composite endpoint of major and clinically relevant non-major bleeding
Description
All suspected events were reviewed and classified by the Central Independent Adjudication Committee.
Time Frame
Up to 15 days
Secondary Outcome Measure Information:
Title
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
Description
All suspected events were reviewed and classified by the Central Independent Adjudication Committee.
Time Frame
Up to 157 days
Title
Incidence of composite endpoint of major and clinically relevant non-major bleeding
Description
All suspected events were reviewed and classified by the Central Independent Adjudication Committee.
Time Frame
Up to 157 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
Facility Name
UMHAT Sveti Georgi
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Acibadem City Clinic Multiprofile Hospital for Active Treatm
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
UMHAT Tsaritsa Joanna-ISUL EAD Sofia
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
Medical Investigative & Clinical Evaluation Inc.
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1E6
Country
Canada
Facility Name
Fakultni nemocnice u sv. Anny
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Nemocnice Ceske Budejovice, a.s.
City
Ceske Budejovice
ZIP/Postal Code
370 87
Country
Czechia
Facility Name
Okresni nemocnice Jindrichuv Hradec
City
Jindrichuv Hradec
ZIP/Postal Code
377 38
Country
Czechia
Facility Name
Regional Hospital Pardubice
City
Pardubice
ZIP/Postal Code
530 03
Country
Czechia
Facility Name
KAT General Hospital of Athens
City
Kifisia
ZIP/Postal Code
14561
Country
Greece
Facility Name
Konstantopoulio General Hospital of Nea Ionia - Agia Olga
City
Nea Ionia
ZIP/Postal Code
14233
Country
Greece
Facility Name
University General Hospital of Patras
City
Patras
ZIP/Postal Code
265 04
Country
Greece
Facility Name
Papageorgiou General Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
56403
Country
Greece
Facility Name
Rambam Health Corporation
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Lady Davis Carmel Medical Center
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Meir Medical Center
City
Kfar-Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Clalit Health Services through Rabin Medical Center - Beilinson Campus
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
7610001
Country
Israel
Facility Name
Liepaja Regional Hospital
City
Liepaja
ZIP/Postal Code
LV-3414
Country
Latvia
Facility Name
Riga 2nd City Hospital
City
Riga
ZIP/Postal Code
LV-1004
Country
Latvia
Facility Name
Hospital of Traumatology and Orthopaedics
City
Riga
ZIP/Postal Code
LV-1005
Country
Latvia
Facility Name
Valmiera Hospital
City
Valmiera
ZIP/Postal Code
LV-4201
Country
Latvia
Facility Name
Kaunas clinical hospital (Laisves ave.)
City
Kaunas
ZIP/Postal Code
LT-44320
Country
Lithuania
Facility Name
Lithuanian university of Health science
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
PI Klaipedos University Hospital
City
Klaipeda
ZIP/Postal Code
LT-92288
Country
Lithuania
Facility Name
Republican Vilnius University Hospital
City
Vilnius
ZIP/Postal Code
LT-04130
Country
Lithuania
Facility Name
Vilnius University Hospital Santaros Klinikos
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Uniwersytecki Szpital Kliniczny w Bialymstoku
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Wojewódzki Szpital Zespolony
City
Kielce
Country
Poland
Facility Name
Szpital Specjalistyczny im. Rydygiera
City
Krakow
ZIP/Postal Code
31-826
Country
Poland
Facility Name
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
City
Lodz
ZIP/Postal Code
92-213
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZ
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny UM we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Hospital de Cascais
City
Alcabideche
State/Province
Lisboa
ZIP/Postal Code
2755-009
Country
Portugal
Facility Name
CHS - Hospital Ortopedico Sant Iago do Outao
City
Setubal
State/Province
Setúbal
ZIP/Postal Code
2900-182
Country
Portugal
Facility Name
CHBV - Hospital Infante D. Pedro
City
Aveiro
ZIP/Postal Code
3810-501
Country
Portugal
Facility Name
CHL - Hospital Santo Andre
City
Leiria
ZIP/Postal Code
2410-197
Country
Portugal
Facility Name
ULSAM - Hospital Santa Luzia
City
Viana do Castelo
ZIP/Postal Code
4901-858
Country
Portugal
Facility Name
Russian Scientific Center n.a. acad. G.A. Ilizarov
City
Kurgan
ZIP/Postal Code
640014
Country
Russian Federation
Facility Name
Privolzhskiy Federal Medical Research Center
City
Nizhny Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Facility Name
City Hospital #2
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Sci-Res. Institute of Traumatology and Orthopaedia
City
St. Petersburg
ZIP/Postal Code
195427
Country
Russian Federation
Facility Name
Clinical Hospital for Emergency Care n.a. N.V.Solovyov
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Pretoria Academic Hospital New
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0084
Country
South Africa
Facility Name
UCT Clinical Research Centre
City
Cape Town
State/Province
Western Cape
Country
South Africa
Facility Name
Clinical Projects Research SA
City
Worcester
State/Province
Western Cape
ZIP/Postal Code
6850
Country
South Africa
Facility Name
Ciutat Sanitària i Universitària de Bellvitge
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Fundación Hospital Alcorcón
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Ciutat Sanitària i Universitaria de la Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clínic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Complejo Hospitalario de Jaén
City
Jaén
ZIP/Postal Code
23009
Country
Spain
Facility Name
Hospital Clínico Universitario San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Cherkasy Reg Clinical Hospital of Cherkasy Reg Council
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Ivano-Frankivsk Regional Clinical Hospital
City
Ivano-Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
Kyiv Regional Clinical Hospital
City
Kyiv
ZIP/Postal Code
4107
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
31935028
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.
Results Reference
derived
Links:
URL
https://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer products

Learn more about this trial

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

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