Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 7, 2017
First Posted Date  ICMJE September 8, 2017
Last Update Posted Date March 3, 2020
Actual Study Start Date  ICMJE September 21, 2017
Actual Primary Completion Date August 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2020)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2017)
  • 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 Visit 7 (Day 12+3) ]
    DVT: deep vein thrombosis PE: pulmonary embolism All suspected events will be 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 Visit 7 (Day 12+3) ]
    All suspected events will be reviewed and classified by the Central Independent Adjudication Committee
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2020)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2017)
  • Incidence of composite endpoint of symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded up to Day 150 or objectively confirmed asymptomatic DVT up to day 12 [ Time Frame: up to Visit 10 (Day 150±7) ]
    All suspected events will be 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 Visit 10 (Day 150±7) ]
    All suspected events will be reviewed and classified by the Central Independent Adjudication Committee
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FactOr XIa inhibiTion for the pRevention of venOus Thromboembolism in Patients Undergoing Total Knee Arthroplasty
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Knee Arthroplasty, Total
Intervention  ICMJE
  • Drug: Enoxaparin
    40 mg enoxaparin administered as subcutaneous injection once daily
  • Drug: Apixaban
    2.5 mg apixaban administered as tablet orally twice daily
  • Drug: BAY1213790
    Single dose of BAY1213790 administered as intravenous infusion
    Other Name: Osocimab
Study Arms  ICMJE
  • Active Comparator: Enoxaparin
    Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received enoxaparin for at least 10 days until venography was performed.
    Intervention: Drug: Enoxaparin
  • Active Comparator: Apixaban
    Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received apixaban for at least 10 days until venography was performed.
    Intervention: Drug: Apixaban
  • 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.
    Intervention: Drug: BAY1213790
  • 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.
    Intervention: Drug: BAY1213790
  • 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.
    Intervention: Drug: BAY1213790
  • 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.
    Intervention: Drug: BAY1213790
  • 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.
    Intervention: Drug: BAY1213790
  • 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.
    Intervention: Drug: BAY1213790
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 28, 2020)
813
Original Estimated Enrollment  ICMJE
 (submitted: September 7, 2017)
700
Actual Study Completion Date  ICMJE January 2, 2019
Actual Primary Completion Date August 20, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Canada,   Czechia,   Greece,   Israel,   Latvia,   Lithuania,   Poland,   Portugal,   Russian Federation,   South Africa,   Spain,   Ukraine
Removed Location Countries Germany,   Hungary
 
Administrative Information
NCT Number  ICMJE NCT03276143
Other Study ID Numbers  ICMJE 17664
2016-002681-31 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP