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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03276143
• Date of registration: 07/09/2017
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: FactOr XIa inhibiTion for the pRevention of venOus Thromboembolism in Patients Undergoing Total Knee Arthroplasty FOXTROT
• Scientific 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
• Date of first enrolment: September 21, 2017
• Target sample size: 813
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03276143
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Bulgaria, Canada, Czechia, Germany, Greece, Hungary, Israel, Latvia, Lithuania, Poland, Portugal, Russian Federation, South Africa, Spain, Ukraine

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Knee Arthroplasty, Total

Intervention(s)

Drug: Apixaban

Drug: BAY1213790

Drug: Enoxaparin

Primary Outcome(s)

Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral venography, objectively confirmed symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded [Time Frame: Up to 15 days]

Incidence of composite endpoint of major and clinically relevant non-major bleeding [Time Frame: Up to 15 days]

Secondary Outcome(s)

Incidence of composite endpoint of symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded up to Day 157 or objectively confirmed asymptomatic DVT up to Day 15 [Time Frame: Up to 157 days]

Incidence of composite endpoint of major and clinically relevant non-major bleeding [Time Frame: Up to 157 days]

Secondary ID(s)

2016-002681-31

17664

Source(s) of Monetary Support

Please refer to primary and secondary sponsors