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

Bayer

Status and phase: Completed; Phase 2

Conditions: Knee Arthroplasty, Total

Treatments: Drug: Enoxaparin; Drug: Apixaban; Drug: BAY1213790

Study type: Interventional

Funder types: Industry

Identifiers

NCT03276143

17664

2016-002681-31 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 813 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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813 participants in 8 patient groups

Enoxaparin

Active Comparator group

Description:

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received enoxaparin for at least 10 days until venography was performed.

Treatment:

Drug: Enoxaparin

Apixaban

Active Comparator group

Description:

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received apixaban for at least 10 days until venography was performed.

Treatment:

Drug: Apixaban

BAY1213790 0.3 mg/kg (post-surgery)

Experimental group

Description:

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.3 mg BAY1213790 once post-surgery.

Treatment:

Drug: BAY1213790

BAY1213790 0.6 mg/kg (post-surgery)

Experimental group

Description:

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.6 mg BAY1213790 once post-surgery.

Treatment:

Drug: BAY1213790

BAY1213790 1.2 mg/kg (post-surgery)

Experimental group

Description:

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.2 mg BAY1213790 once post-surgery.

Treatment:

Drug: BAY1213790

BAY1213790 1.8 mg/kg (post-surgery)

Experimental group

Description:

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.8 mg BAY1213790 once post-surgery.

Treatment:

Drug: BAY1213790

BAY1213790 0.3 mg/kg (pre-surgery)

Experimental group

Description:

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.3 mg BAY1213790 once pre-surgery.

Treatment:

Drug: BAY1213790

BAY1213790 1.8 mg/kg (pre-surgery)

Experimental group

Description:

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.8 mg BAY1213790 once pre-surgery.

Treatment:

Drug: BAY1213790