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

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ClinicalTrials.gov Identifier: NCT03276143
Recruitment Status : Completed
First Posted : September 8, 2017
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment Phase
Knee Arthroplasty, Total Drug: Enoxaparin Drug: Apixaban Drug: BAY1213790 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 813 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : September 21, 2017
Actual Primary Completion Date : August 20, 2018
Actual Study Completion Date : January 2, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
Drug Information available for: Apixaban

Arm Intervention/treatment
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Osocimab




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03276143


Locations
Show Show 54 study locations
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03276143    
Other Study ID Numbers: 17664
2016-002681-31 ( EudraCT Number )
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Orthopedic surgery
Venous thromboembolism
Deep vein thrombosis (DVT)
Anticoagulation
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Enoxaparin
Apixaban
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors