A Study to Investigate Different Doses of BAY1213790 to Prevent Blood Clots in Patients Undergoing Elective Total Knee Replacement Surgery (FOXTROT)

This study is to compare the study drug BAY1213790 to existing therapies, ie Enoxaparin or Apixaban for the prevention of blood clotting and safety in patients undergoing total knee arthroplasty (TKA). The study is open-label, but observer-blind for the different doses of BAY1213790 administered. This means that it is known which treatment is given, but it is not known which dose of BAY1213790 is administered.


Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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
Estimated Enrollment: 700
Actual Study Start Date: September 21, 2017
Estimated Study Completion Date: July 15, 2019
Estimated Primary Completion Date: June 13, 2019 (Final data collection date for primary outcome measure)

Arms:
- Experimental: BAY1213790 pre and post surgery
- Active Comparator: Enoxaparin for at least 10 days
- Active Comparator: Apixaban for at least 10 days