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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03276143

Acronym

FOXTROT

Enrollment

813

Registered

2017-09-08

Start date

2017-09-21

Completion date

2019-01-02

Last updated

2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Arthroplasty, Total

Keywords

Orthopedic surgery, Venous thromboembolism, Deep vein thrombosis (DVT), Anticoagulation

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.

Interventions

DRUGEnoxaparin

40 mg enoxaparin administered as subcutaneous injection once daily

DRUGApixaban

2.5 mg apixaban administered as tablet orally twice daily

DRUGBAY1213790

Single dose of BAY1213790 administered as intravenous infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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	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	Up to 15 days	All suspected events were reviewed and classified by the Central Independent Adjudication Committee.

Secondary

Measure	Time frame	Description
Incidence of composite endpoint of major and clinically relevant non-major bleeding	Up to 157 days	All suspected events were reviewed and classified by the Central Independent Adjudication Committee.
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	Up to 157 days	All suspected events were reviewed and classified by the Central Independent Adjudication Committee.

Countries

Bulgaria, Canada, Czechia, Greece, Israel, Latvia, Lithuania, Poland, Portugal, Russia, South Africa, Spain, Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026