Status:
COMPLETED
FactOr XIa inhibiTion for the pRevention of venOus Thromboembolism in Patients Undergoing Total Knee Arthroplasty
Lead Sponsor:
Bayer
Conditions:
Knee Arthroplasty, Total
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 (...
Eligibility Criteria
Inclusion
- Patients aged ≥18 years and undergoing elective primary, unilateral Total Knee Arthroplasty (TKA)
- Women of non-childbearing potential
Exclusion
- 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
Key Trial Info
Start Date :
September 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 2 2019
Estimated Enrollment :
813 Patients enrolled
Trial Details
Trial ID
NCT03276143
Start Date
September 21 2017
End Date
January 2 2019
Last Update
March 3 2020
Active Locations (54)
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1
UMHAT Sveti Georgi
Plovdiv, Bulgaria, 4002
2
Acibadem City Clinic Multiprofile Hospital for Active Treatm
Sofia, Bulgaria, 1407
3
UMHAT Tsaritsa Joanna-ISUL EAD Sofia
Sofia, Bulgaria, 1527
4
Medical Investigative & Clinical Evaluation Inc.
Windsor, Ontario, Canada, N8W 1E6