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

Bayer813 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

813

Conditions

Knee Arthroplasty, Total

Interventions

EnoxaparinDRUG

40 mg enoxaparin administered as subcutaneous injection once daily

ApixabanDRUG

2.5 mg apixaban administered as tablet orally twice daily

BAY1213790DRUG

Single dose of BAY1213790 administered as intravenous infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (54)

Outcomes

Primary Outcomes

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

DVT - Deep vein thrombosis / PE - Pulmonary embolism All suspected events were reviewed and classified by the Central Independent Adjudication Committee.

Time frame: Up to 15 days

Incidence of composite endpoint of major and clinically relevant non-major bleeding

All suspected events were reviewed and classified by the Central Independent Adjudication Committee.

Time frame: Up to 15 days

Secondary Outcomes

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

All suspected events were reviewed and classified by the Central Independent Adjudication Committee.

Time frame: Up to 157 days

Incidence of composite endpoint of major and clinically relevant non-major bleeding

All suspected events were reviewed and classified by the Central Independent Adjudication Committee.

Time frame: Up to 157 days

Data from ClinicalTrials.gov

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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.

České Budějovice, Czechia

Okresni nemocnice Jindrichuv Hradec

Jindřichův Hradec, Czechia

Regional Hospital Pardubice

Pardubice, Czechia

KAT General Hospital of Athens

Kifissia, Greece

Konstantopoulio General Hospital of Nea Ionia - Agia Olga

Nea Ionia, Greece

...and 44 more locations