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

February 28, 2020 updated by: Bayer

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
813

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • UMHAT Sveti Georgi
      • Sofia, Bulgaria, 1527
        • UMHAT Tsaritsa Joanna-ISUL EAD Sofia
      • Sofia, Bulgaria, 1407
        • Acibadem City Clinic Multiprofile Hospital for Active Treatm
  • Canada
    • Ontario
      • Windsor, Ontario, Canada, N8W 1E6
        • Medical Investigative & Clinical Evaluation Inc.
  • Czechia
      • Brno, Czechia, 656 91
        • Fakultni nemocnice u sv. Anny
      • Ceske Budejovice, Czechia, 370 87
        • Nemocnice Ceske Budejovice, a.s.
      • Jindrichuv Hradec, Czechia, 377 38
        • Okresni nemocnice Jindrichuv Hradec
      • Pardubice, Czechia, 530 03
        • Regional Hospital Pardubice
  • Greece
      • Kifisia, Greece, 14561
        • KAT General Hospital of Athens
      • Nea Ionia, Greece, 14233
        • Konstantopoulio General Hospital of Nea Ionia - AGIA OLGA
      • Patras, Greece, 265 04
        • University General Hospital of Patras
      • Thessaloniki, Greece, 56403
        • Papageorgiou General Hospital of Thessaloniki
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Health Corporation
      • Haifa, Israel, 3436212
        • Lady Davis Carmel Medical Center
      • Kfar-Saba, Israel, 4428164
        • Meir Medical Center
      • Petah Tikva, Israel, 4941492
        • Clalit Health Services through Rabin Medical Center - Beilinson Campus
      • Rehovot, Israel, 7610001
        • Kaplan Medical Center
  • Latvia
      • Liepaja, Latvia, LV-3414
        • Liepaja Regional Hospital
      • Riga, Latvia, LV-1004
        • Riga 2nd City Hospital
      • Riga, Latvia, LV-1005
        • Hospital of Traumatology and Orthopaedics
      • Valmiera, Latvia, LV-4201
        • Valmiera Hospital
  • Lithuania
      • Kaunas, Lithuania, LT-44320
        • Kaunas clinical hospital (Laisves ave.)
      • Kaunas, Lithuania, LT-50009
        • Lithuanian University of Health Science
      • Klaipeda, Lithuania, LT-92288
        • PI Klaipedos University Hospital
      • Vilnius, Lithuania, LT-08661
        • Vilnius University Hospital Santaros Klinikos
      • Vilnius, Lithuania, LT-04130
        • Republican Vilnius University hospital
  • Poland
      • Bialystok, Poland, 15-276
        • Uniwersytecki Szpital Kliniczny W Bialymstoku
      • Kielce, Poland
        • Wojewodzki Szpital Zespolony
      • Krakow, Poland, 31-826
        • Szpital Specjalistyczny im. Rydygiera
      • Lodz, Poland, 92-213
        • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
      • Lublin, Poland, 20-718
        • Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZ
      • Wroclaw, Poland, 50-556
        • Uniwersytecki Szpital Kliniczny UM we Wroclawiu
  • Portugal
      • Aveiro, Portugal, 3810-501
        • CHBV - Hospital Infante D. Pedro
      • Leiria, Portugal, 2410-197
        • CHL - Hospital Santo Andre
      • Viana do Castelo, Portugal, 4901-858
        • ULSAM - Hospital Santa Luzia
    • Lisboa
      • Alcabideche, Lisboa, Portugal, 2755-009
        • Hospital de Cascais
    • Setúbal
      • Setubal, Setúbal, Portugal, 2900-182
        • CHS - Hospital Ortopedico Sant Iago do Outao
  • Russian Federation
      • Kurgan, Russian Federation, 640014
        • Russian Scientific Center n.a. acad. G.A. Ilizarov
      • Nizhny Novgorod, Russian Federation, 603155
        • Privolzhskiy Federal Medical Research Center
      • St. Petersburg, Russian Federation, 194354
        • City Hospital #2
      • St. Petersburg, Russian Federation, 195427
        • Sci-Res. Institute of Traumatology and Orthopaedia
      • Yaroslavl, Russian Federation, 150003
        • Clinical Hospital for Emergency Care n.a. N.V.Solovyov
  • South Africa
    • Gauteng
      • Pretoria, Gauteng, South Africa, 0084
        • Pretoria Academic Hospital New
    • Western Cape
      • Cape Town, Western Cape, South Africa
        • UCT Clinical Research Centre
      • Worcester, Western Cape, South Africa, 6850
        • Clinical Projects Research SA
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clínic i Provincial de Barcelona
      • Barcelona, Spain, 08035
        • Ciutat Sanitaria i Universitaria de la Vall d'Hebron
      • Jaén, Spain, 23009
        • Complejo Hospitalario de Jaén
      • Madrid, Spain, 28040
        • Hospital Clinico Universitario San Carlos
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Ciutat Sanitaria i Universitaria de Bellvitge
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Fundacion Hospital Alcorcon
  • Ukraine
      • Cherkasy, Ukraine, 18009
        • Cherkasy Reg Clinical Hospital of Cherkasy Reg Council
      • Ivano-Frankivsk, Ukraine, 76008
        • Ivano-Frankivsk Regional Clinical Hospital
      • Kyiv, Ukraine, 4107
        • Kyiv Regional Clinical Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Enoxaparin
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received enoxaparin for at least 10 days until venography was performed.
Drug: Enoxaparin
40 mg enoxaparin administered as subcutaneous injection once daily
Active Comparator: Apixaban
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received apixaban for at least 10 days until venography was performed.
Drug: Apixaban
2.5 mg apixaban administered as tablet orally twice daily
Experimental: 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.
Drug: BAY1213790
Single dose of BAY1213790 administered as intravenous infusion
Other Names:
  • Osocimab
Experimental: 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.
Drug: BAY1213790
Single dose of BAY1213790 administered as intravenous infusion
Other Names:
  • Osocimab
Experimental: 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.
Drug: BAY1213790
Single dose of BAY1213790 administered as intravenous infusion
Other Names:
  • Osocimab
Experimental: 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.
Drug: BAY1213790
Single dose of BAY1213790 administered as intravenous infusion
Other Names:
  • Osocimab
Experimental: 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.
Drug: BAY1213790
Single dose of BAY1213790 administered as intravenous infusion
Other Names:
  • Osocimab
Experimental: 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.
Drug: BAY1213790
Single dose of BAY1213790 administered as intravenous infusion
Other Names:
  • Osocimab

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: Up to 15 days
DVT - Deep vein thrombosis / PE - Pulmonary embolism All suspected events were reviewed and classified by the Central Independent Adjudication Committee.
Up to 15 days
Incidence of composite endpoint of major and clinically relevant non-major bleeding
Time Frame: Up to 15 days
All suspected events were reviewed and classified by the Central Independent Adjudication Committee.
Up to 15 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: Up to 157 days
All suspected events were reviewed and classified by the Central Independent Adjudication Committee.
Up to 157 days
Incidence of composite endpoint of major and clinically relevant non-major bleeding
Time Frame: Up to 157 days
All suspected events were reviewed and classified by the Central Independent Adjudication Committee.
Up to 157 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 20, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 2, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17664
  • 2016-002681-31 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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