NCT03276143

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 813 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Arthroplasty, Total

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-09-21
• Primary completion: 2018-08-20
• Completion: 2019-01-02
• First posted: 2017-09-08
• Last updated: 2020-03-03

Locations

54 sites across 13 countries: Bulgaria, Canada, Czechia, Greece, Israel, Latvia, Lithuania, Poland, Portugal, Russia, South Africa, Spain, Ukraine