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)

Republican Vilnius University Hospital; 🇱🇹 Vilnius, Lithuania

Wojewódzki Szpital Zespolony; 🇵🇱 Kielce, Poland

Szpital Specjalistyczny im. Rydygiera; 🇵🇱 Krakow, Poland

Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi; 🇵🇱 Lodz, Poland

Hospital de Cascais; 🇵🇹 Alcabideche, Lisboa, Portugal

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

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

Regional Hospital Pardubice; 🇨🇿 Pardubice, Czechia

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

Hospital Clínic i Provincial de Barcelona; 🇪🇸 Barcelona, Spain

Lithuanian university of Health science; 🇱🇹 Kaunas, Lithuania

Okresni nemocnice Jindrichuv Hradec; 🇨🇿 Jindrichuv Hradec, Czechia

Pretoria Academic Hospital New; 🇿🇦 Pretoria, Gauteng, South Africa

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

Riga 2nd City Hospital; 🇱🇻 Riga, Latvia

Hospital of Traumatology and Orthopaedics; 🇱🇻 Riga, Latvia

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

Uniwersytecki Szpital Kliniczny w Bialymstoku; 🇵🇱 Bialystok, Poland

CHL - Hospital Santo Andre; 🇵🇹 Leiria, Portugal

Russian Scientific Center n.a. acad. G.A. Ilizarov; 🇷🇺 Kurgan, Russian Federation

Complejo Hospitalario de Jaén; 🇪🇸 Jaén, Spain

Ciutat Sanitària i Universitària de Bellvitge; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain

Liepaja Regional Hospital; 🇱🇻 Liepaja, Latvia

Hospital Clínico Universitario San Carlos; 🇪🇸 Madrid, Spain

Clinical Hospital for Emergency Care n.a. N.V.Solovyov; 🇷🇺 Yaroslavl, Russian Federation

Privolzhskiy Federal Medical Research Center; 🇷🇺 Nizhny Novgorod, Russian Federation

City Hospital #2; 🇷🇺 St. Petersburg, Russian Federation

Fundación Hospital Alcorcón; 🇪🇸 Alcorcón, Madrid, Spain

Sci-Res. Institute of Traumatology and Orthopaedia; 🇷🇺 St. Petersburg, Russian Federation

UMHAT Sveti Georgi; 🇧🇬 Plovdiv, Bulgaria

KAT General Hospital of Athens; 🇬🇷 Kifisia, Greece

University General Hospital of Patras; 🇬🇷 Patras, Greece

Rambam Health Corporation; 🇮🇱 Haifa, Israel

Lady Davis Carmel Medical Center; 🇮🇱 Haifa, Israel

Meir Medical Center; 🇮🇱 Kfar-Saba, Israel

Clalit Health Services through Rabin Medical Center - Beilinson Campus; 🇮🇱 Petah Tikva, Israel

Kaplan Medical Center; 🇮🇱 Rehovot, Israel

Ciutat Sanitària i Universitaria de la Vall d'Hebron; 🇪🇸 Barcelona, Spain

UCT Clinical Research Centre; 🇿🇦 Cape Town, Western Cape, South Africa

Vilnius University Hospital Santaros Klinikos; 🇱🇹 Vilnius, Lithuania

CHBV - Hospital Infante D. Pedro; 🇵🇹 Aveiro, Portugal

ULSAM - Hospital Santa Luzia; 🇵🇹 Viana do Castelo, Portugal

Kyiv Regional Clinical Hospital; 🇺🇦 Kyiv, Ukraine

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

Papageorgiou General Hospital of Thessaloniki; 🇬🇷 Thessaloniki, Greece

Valmiera Hospital; 🇱🇻 Valmiera, Latvia

Kaunas clinical hospital (Laisves ave.); 🇱🇹 Kaunas, Lithuania

PI Klaipedos University Hospital; 🇱🇹 Klaipeda, Lithuania

Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZ; 🇵🇱 Lublin, Poland

Uniwersytecki Szpital Kliniczny UM we Wroclawiu; 🇵🇱 Wroclaw, Poland

Cherkasy Reg Clinical Hospital of Cherkasy Reg Council; 🇺🇦 Cherkasy, Ukraine

Ivano-Frankivsk Regional Clinical Hospital; 🇺🇦 Ivano-Frankivsk, Ukraine

CHS - Hospital Ortopedico Sant Iago do Outao; 🇵🇹 Setubal, Setúbal, Portugal

Clinical Projects Research SA; 🇿🇦 Worcester, Western Cape, South Africa