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

• Status: Completed
• Trial end date: 2019-01-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Apixaban; Enoxaparin

Criteria

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