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

Phase 2

Completed

• Conditions: Knee Arthroplasty, Total
• Interventions: Drug: BAY1213790; Drug: Enoxaparin; Drug: Apixaban

• Registration Number: NCT03276143
• Lead Sponsor: Bayer

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 (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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-07
• Study First Submitted QC: 2017-09-07
• Study First Posted: 2017-09-08
• Study Start: 2017-09-21
• Primary Completion: 2018-08-20
• Study Completion: 2019-01-02
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-28
• Last Update Posted: 2020-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 813

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BAY1213790 0.6 mg/kg (post-surgery)	BAY1213790	Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.6 mg BAY1213790 once post-surgery.
BAY1213790 0.3 mg/kg (pre-surgery)	BAY1213790	Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.3 mg BAY1213790 once pre-surgery.
BAY1213790 1.8 mg/kg (pre-surgery)	BAY1213790	Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.8 mg BAY1213790 once pre-surgery.
BAY1213790 0.3 mg/kg (post-surgery)	BAY1213790	Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.3 mg BAY1213790 once post-surgery.
BAY1213790 1.2 mg/kg (post-surgery)	BAY1213790	Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.2 mg BAY1213790 once post-surgery.
BAY1213790 1.8 mg/kg (post-surgery)	BAY1213790	Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.8 mg BAY1213790 once post-surgery.
Enoxaparin	Enoxaparin	Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received enoxaparin for at least 10 days until venography was performed.
Apixaban	Apixaban	Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received apixaban for at least 10 days until venography was performed.

Primary Outcome Measures

Name	Time	Method
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	Up to 15 days	DVT - Deep vein thrombosis / PE - Pulmonary embolism All suspected events were reviewed and classified by the Central Independent Adjudication Committee.
Incidence of composite endpoint of major and clinically relevant non-major bleeding	Up to 15 days	All suspected events were reviewed and classified by the Central Independent Adjudication Committee.

Secondary Outcome Measures

Name	Time	Method
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	Up to 157 days	All suspected events were reviewed and classified by the Central Independent Adjudication Committee.
Incidence of composite endpoint of major and clinically relevant non-major bleeding	Up to 157 days	All suspected events were reviewed and classified by the Central Independent Adjudication Committee.

Trial Locations

Locations (54)

UMHAT Sveti Georgi; 🇧🇬 Plovdiv, Bulgaria

Acibadem City Clinic Multiprofile Hospital for Active Treatm; 🇧🇬 Sofia, Bulgaria

UMHAT Tsaritsa Joanna-ISUL EAD Sofia; 🇧🇬 Sofia, Bulgaria

Medical Investigative & Clinical Evaluation Inc.; 🇨🇦 Windsor, Ontario, Canada

Fakultni nemocnice u sv. Anny; 🇨🇿 Brno, Czechia

Nemocnice Ceske Budejovice, a.s.; 🇨🇿 Ceske Budejovice, Czechia

Okresni nemocnice Jindrichuv Hradec; 🇨🇿 Jindrichuv Hradec, Czechia

Regional Hospital Pardubice; 🇨🇿 Pardubice, Czechia

KAT General Hospital of Athens; 🇬🇷 Kifisia, Greece

Konstantopoulio General Hospital of Nea Ionia - Agia Olga; 🇬🇷 Nea Ionia, Greece

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