Knee Arthroplasty, TotalPhase 2FOXTROTNCT03276143
FactOr XIa inhibiTion for the pRevention of venOus Thromboembolism in Patients Undergoing Total Knee Arthroplasty
A Phase 2 study testing Enoxaparin, Apixaban and BAY1213790 in people with Knee Arthroplasty, Total, run by Bayer at 54 sites in 13 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthroplasty, Total
- What is being tested?
- Enoxaparin, Apixaban and BAY1213790
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 813 participants
- Where
- 54 sitesin 13 countries
- Study dates
- 21 Sep 2017to 2 Jan 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥18 years and undergoing elective primary, unilateral Total Knee Arthroplasty (TKA)
- Women of non-childbearing potential
Who cannot join
- 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
Trial locations and contacts
54 sites in 13 countries.
54 sites in 13 countries
Poland6 sites
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15-276
Wojewódzki Szpital Zespolony
Kielce
Szpital Specjalistyczny im. Rydygiera
Krakow, 31-826
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
Lodz, 92-213
Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZ
Lublin, 20-718
Uniwersytecki Szpital Kliniczny UM we Wroclawiu
Wroclaw, 50-556
Spain6 sites
Fundación Hospital Alcorcón
Alcorcón, Madrid, 28922
Ciutat Sanitària i Universitaria de la Vall d'Hebron
Barcelona, 08035
Hospital Clínic i Provincial de Barcelona
Barcelona, 08036
Complejo Hospitalario de Jaén
Jaén, 23009
Ciutat Sanitària i Universitària de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Clínico Universitario San Carlos
Madrid, 28040
Israel5 sites
Rambam Health Corporation
Haifa, 3109601
Lady Davis Carmel Medical Center
Haifa, 3436212
Meir Medical Center
Kfar Saba, 4428164
Clalit Health Services through Rabin Medical Center - Beilinson Campus
Petah Tikva, 4941492
Kaplan Medical Center
Rehovot, 7610001
Lithuania5 sites
Kaunas clinical hospital (Laisves ave.)
Kaunas, LT-44320
Lithuanian university of Health science
Kaunas, LT-50009
PI Klaipedos University Hospital
Klaipėda, LT-92288
Republican Vilnius University Hospital
Vilnius, LT-04130
Vilnius University Hospital Santaros Klinikos
Vilnius, LT-08661
Portugal5 sites
Hospital de Cascais
Alcabideche, Lisbon District, 2755-009
CHBV - Hospital Infante D. Pedro
Aveiro, 3810-501
CHL - Hospital Santo Andre
Leiria, 2410-197
CHS - Hospital Ortopedico Sant Iago do Outao
Setúbal, Setúbal District, 2900-182
ULSAM - Hospital Santa Luzia
Viana do Castelo, 4901-858
Russia5 sites
Russian Scientific Center n.a. acad. G.A. Ilizarov
Kurgan, 640014
Privolzhskiy Federal Medical Research Center
Nizhny Novgorod, 603155
City Hospital #2
Saint Petersburg, 194354
Sci-Res. Institute of Traumatology and Orthopaedia
Saint Petersburg, 195427
Clinical Hospital for Emergency Care n.a. N.V.Solovyov
Yaroslavl, 150003
Czechia4 sites
Fakultni nemocnice u sv. Anny
Brno, 656 91
Nemocnice Ceske Budejovice, a.s.
České Budějovice, 370 87
Okresni nemocnice Jindrichuv Hradec
Jindřichův Hradec, 377 38
Regional Hospital Pardubice
Pardubice, 530 03
Greece4 sites
KAT General Hospital of Athens
Kifissia, 14561
Konstantopoulio General Hospital of Nea Ionia - Agia Olga
Nea Ionia, 14233
University General Hospital of Patras
Pátrai, 265 04
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, 56403
Latvia4 sites
Liepaja Regional Hospital
Liepāja, LV-3414
Riga 2nd City Hospital
Riga, LV-1004
Hospital of Traumatology and Orthopaedics
Riga, LV-1005
Valmiera Hospital
Valmiera, LV-4201
Bulgaria3 sites
UMHAT Sveti Georgi
Plovdiv, 4002
Acibadem City Clinic Multiprofile Hospital for Active Treatm
Sofia, 1407
UMHAT Tsaritsa Joanna-ISUL EAD Sofia
Sofia, 1527
South Africa3 sites
UCT Clinical Research Centre
Cape Town, Western Cape
Pretoria Academic Hospital New
Pretoria, Gauteng, 0084
Clinical Projects Research SA
Worcester, Western Cape, 6850
Ukraine3 sites
Cherkasy Reg Clinical Hospital of Cherkasy Reg Council
Cherkasy, 18009
Ivano-Frankivsk Regional Clinical Hospital
Ivano-Frankivsk, 76008
Kyiv Regional Clinical Hospital
Kyiv, 4107
Canada1 site
Medical Investigative & Clinical Evaluation Inc.
Windsor, Ontario, N8W 1E6
About this study
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
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.
- Conditions
- Knee Arthroplasty, Total
- Being tested
- Enoxaparin, Apixaban, BAY1213790
- Keywords
- Orthopedic surgery, Venous thromboembolism, Deep vein thrombosis (DVT), Anticoagulation
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
40 mg enoxaparin administered as subcutaneous injection once daily
ApixabanDrug
2.5 mg apixaban administered as tablet orally twice daily
BAY1213790Drug
Also called Osocimab
Single dose of BAY1213790 administered as intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Enoxaparin | Active comparator | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received enoxaparin for at least 10 days until venography was performed. Receives: Drug: Enoxaparin |
| Apixaban | Active comparator | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received apixaban for at least 10 days until venography was performed. Receives: Drug: Apixaban |
| BAY1213790 0.3 mg/kg (post-surgery) | Experimental | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.3 mg BAY1213790 once post-surgery. Receives: Drug: BAY1213790 |
| BAY1213790 0.6 mg/kg (post-surgery) | Experimental | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.6 mg BAY1213790 once post-surgery. Receives: Drug: BAY1213790 |
| BAY1213790 1.2 mg/kg (post-surgery) | Experimental | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.2 mg BAY1213790 once post-surgery. Receives: Drug: BAY1213790 |
| BAY1213790 1.8 mg/kg (post-surgery) | Experimental | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.8 mg BAY1213790 once post-surgery. Receives: Drug: BAY1213790 |
| BAY1213790 0.3 mg/kg (pre-surgery) | Experimental | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.3 mg BAY1213790 once pre-surgery. Receives: Drug: BAY1213790 |
| BAY1213790 1.8 mg/kg (pre-surgery) | Experimental | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.8 mg BAY1213790 once pre-surgery. Receives: Drug: BAY1213790 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 15 days
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.
Measured: Up to 15 days
Secondary outcomes (2)
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.
Measured: Up to 157 days
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.
Measured: Up to 157 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start21 Sep 2017
- Primary completion20 Aug 2018
- Study completion2 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee Arthroplasty, TotalStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 813 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276143
- Sponsor's protocol ID
- 17664
- Other IDs
- 2016-002681-31, 2016
- Acronym
- FOXTROT
- Status last verified
- Feb 2020
- First submitted
- 7 Sep 2017
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31935028
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03276143
- Acronym / sponsor ID
- FOXTROT / 17664
- Conditions
- Knee Arthroplasty, Total
- Keywords
- Orthopedic surgery, Venous thromboembolism, Deep vein thrombosis (DVT), Anticoagulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 813 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 20 Aug 2018 (actual)
- Study completion
- 2 Jan 2019 (actual)
- First posted
- 8 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Enoxaparin | Active comparator | Drug: EnoxaparinAdult patients who underwent Total Knee Arthroplasty (TKA) surgery and received enoxaparin for at least 10 days until venography was performed. |
| Apixaban | Active comparator | Drug: ApixabanAdult patients who underwent Total Knee Arthroplasty (TKA) surgery and received apixaban for at least 10 days until venography was performed. |
| BAY1213790 0.3 mg/kg (post-surgery) | Experimental | Drug: BAY1213790Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.3 mg BAY1213790 once post-surgery. |
| BAY1213790 0.6 mg/kg (post-surgery) | Experimental | Drug: BAY1213790Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.6 mg BAY1213790 once post-surgery. |
| BAY1213790 1.2 mg/kg (post-surgery) | Experimental | Drug: BAY1213790Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.2 mg BAY1213790 once post-surgery. |
| BAY1213790 1.8 mg/kg (post-surgery) | Experimental | Drug: BAY1213790Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.8 mg BAY1213790 once post-surgery. |
| BAY1213790 0.3 mg/kg (pre-surgery) | Experimental | Drug: BAY1213790Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.3 mg BAY1213790 once pre-surgery. |
| BAY1213790 1.8 mg/kg (pre-surgery) | Experimental | Drug: BAY1213790Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.8 mg BAY1213790 once pre-surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged ≥18 years and undergoing elective primary, unilateral Total Knee Arthroplasty (TKA)
- Women of non-childbearing potential
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enoxaparin40 mg enoxaparin administered as subcutaneous injection once daily | Drug | Enoxaparin |
| Apixaban2.5 mg apixaban administered as tablet orally twice daily | Drug | Apixaban |
| BAY1213790Also: OsocimabSingle dose of BAY1213790 administered as intravenous infusion | Drug | BAY1213790 0.3 mg/kg (post-surgery), BAY1213790 0.3 mg/kg (pre-surgery), BAY1213790 0.6 mg/kg (post-surgery), BAY1213790 1.2 mg/kg (post-surgery), BAY1213790 1.8 mg/kg (post-surgery), BAY1213790 1.8 mg/kg (pre-surgery) |
Primary outcome
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.
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.
2 secondary outcomes
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
Incidence of composite endpoint of major and clinically relevant non-major bleeding
Time frame: Up to 157 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Derived from this study: PubMed 31935028Weitz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
54 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enoxaparin, Apixaban and BAY1213790 in people with Knee Arthroplasty, Total, run by Bayer at 54 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in Poland, Spain, Israel, Lithuania, Portugal and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Up to 15 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03276143, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.