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

Phase 2 Completed 813 enrolled Bayer

RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start: 2017-09-21
Primary completion: 2018-08-20
Completion: 2019-01-02

Outcome

Mixed primary results

paper Postoperative and preoperative doses of 0.3 mg/kg of osocimab did not meet the prespecified criteria for noninferiority PMID 31935028 ↗

paper postoperative osocimab 0.6 mg/kg, 1.2 mg/kg, and 1.8 mg/kg met criteria for noninferiority compared with enoxaparin PMID 31935028 ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Apixaban	Small molecule	2.5 mg	Oral
Comparator	Enoxaparin sodium	Other / unclassified	40 mg	Subcutaneous
Subject	Osocimab	Monoclonal antibody	0.3 mg/kg	Intravenous
Subject	Osocimab	Monoclonal antibody	0.6 mg/kg	Intravenous
Subject	Osocimab	Monoclonal antibody	1.2 mg/kg	Intravenous
Subject	Osocimab	Monoclonal antibody	1.8 mg/kg	Intravenous