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Completed

NCT Number: NCT03276143

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

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.

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Key information

Conditions

Knee Arthroplasty, Total Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Thrombosis Vascular Diseases Venous Thromboembolism Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UMHAT Sveti Georgi, Plovdiv, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enoxaparin

Drug

40 mg enoxaparin administered as subcutaneous injection once daily

Apixaban

Drug

2.5 mg apixaban administered as tablet orally twice daily

BAY1213790

Drug

Single dose of BAY1213790 administered as intravenous infusion

Other names: Osocimab

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Acronym: FOXTROT

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Sep 8, 2017
Registry last updated
Mar 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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