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

NCT03276143 | Completed Phase 2 DMC

• 2 other identifiers: 176642016-002681-31
• Study Type: interventional
• Target: 813
• Locations: 13 countries
• Sites: 54

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.

Conditions

Knee Arthroplasty, Total

Keywords

Orthopedic surgery; Venous thromboembolism; Deep vein thrombosis (DVT); Anticoagulation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 15 days

Secondary Outcomes (2)

• 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

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

  Up to 157 days

Study Arms (8)

Enoxaparin

ACTIVE COMPARATOR

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received enoxaparin for at least 10 days until venography was performed.

Drug: Enoxaparin

Apixaban

ACTIVE COMPARATOR

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received apixaban for at least 10 days until venography was performed.

Drug: Apixaban

BAY1213790 0.3 mg/kg (post-surgery)

EXPERIMENTAL

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.3 mg BAY1213790 once post-surgery.

Drug: BAY1213790

BAY1213790 0.6 mg/kg (post-surgery)

EXPERIMENTAL

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.6 mg BAY1213790 once post-surgery.

Drug: BAY1213790

BAY1213790 1.2 mg/kg (post-surgery)

EXPERIMENTAL

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.2 mg BAY1213790 once post-surgery.

Drug: BAY1213790

BAY1213790 1.8 mg/kg (post-surgery)

EXPERIMENTAL

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.8 mg BAY1213790 once post-surgery.

Drug: BAY1213790

BAY1213790 0.3 mg/kg (pre-surgery)

EXPERIMENTAL

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.3 mg BAY1213790 once pre-surgery.

Drug: BAY1213790

BAY1213790 1.8 mg/kg (pre-surgery)

EXPERIMENTAL

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.8 mg BAY1213790 once pre-surgery.

Drug: BAY1213790

Interventions

Enoxaparin DRUG

40 mg enoxaparin administered as subcutaneous injection once daily

Enoxaparin

Apixaban DRUG

2.5 mg apixaban administered as tablet orally twice daily

Apixaban

BAY1213790 DRUG

Single dose of BAY1213790 administered as intravenous infusion

Also known as: Osocimab

BAY1213790 0.3 mg/kg (post-surgery); BAY1213790 0.3 mg/kg (pre-surgery); BAY1213790 0.6 mg/kg (post-surgery); BAY1213790 1.2 mg/kg (post-surgery); BAY1213790 1.8 mg/kg (post-surgery); BAY1213790 1.8 mg/kg (pre-surgery)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥18 years and undergoing elective primary, unilateral Total Knee Arthroplasty (TKA)
• Women of non-childbearing potential

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (54)

UMHAT Sveti Georgi

Plovdiv, 4002, Bulgaria

Location

Acibadem City Clinic Multiprofile Hospital for Active Treatm

Sofia, 1407, Bulgaria

Location

UMHAT Tsaritsa Joanna-ISUL EAD Sofia

Sofia, 1527, Bulgaria

Location

Medical Investigative & Clinical Evaluation Inc.

Windsor, Ontario, N8W 1E6, Canada

Location

Fakultni nemocnice u sv. Anny

Brno, 656 91, Czechia

Location

Nemocnice Ceske Budejovice, a.s.

České Budějovice, 370 87, Czechia

Location

Okresni nemocnice Jindrichuv Hradec

Jindřichův Hradec, 377 38, Czechia

Location

Regional Hospital Pardubice

Pardubice, 530 03, Czechia

Location

KAT General Hospital of Athens

Kifissia, 14561, Greece

Location

Konstantopoulio General Hospital of Nea Ionia - Agia Olga

Nea Ionia, 14233, Greece

Location

University General Hospital of Patras

Pátrai, 265 04, Greece

Location

Papageorgiou General Hospital of Thessaloniki

Thessaloniki, 56403, Greece

Location

Rambam Health Corporation

Haifa, 3109601, Israel

Location

Lady Davis Carmel Medical Center

Haifa, 3436212, Israel

Location

Meir Medical Center

Kfar Saba, 4428164, Israel

Location

Clalit Health Services through Rabin Medical Center - Beilinson Campus

Petah Tikva, 4941492, Israel

Location

Kaplan Medical Center

Rehovot, 7610001, Israel

Location

Liepaja Regional Hospital

Liepāja, LV-3414, Latvia

Location

Riga 2nd City Hospital

Riga, LV-1004, Latvia

Location

Hospital of Traumatology and Orthopaedics

Riga, LV-1005, Latvia

Location

Valmiera Hospital

Valmiera, LV-4201, Latvia

Location

Kaunas clinical hospital (Laisves ave.)

Kaunas, LT-44320, Lithuania

Location

Lithuanian university of Health science

Kaunas, LT-50009, Lithuania

Location

PI Klaipedos University Hospital

Klaipėda, LT-92288, Lithuania

Location

Republican Vilnius University Hospital

Vilnius, LT-04130, Lithuania

Location

Vilnius University Hospital Santaros Klinikos

Vilnius, LT-08661, Lithuania

Location

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, 15-276, Poland

Location

Wojewódzki Szpital Zespolony

Kielce, Poland

Location

Szpital Specjalistyczny im. Rydygiera

Krakow, 31-826, Poland

Location

Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

Lodz, 92-213, Poland

Location

Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZ

Lublin, 20-718, Poland

Location

Uniwersytecki Szpital Kliniczny UM we Wroclawiu

Wroclaw, 50-556, Poland

Location

Hospital de Cascais

Alcabideche, Lisbon District, 2755-009, Portugal

Location

CHS - Hospital Ortopedico Sant Iago do Outao

Setúbal, Setúbal District, 2900-182, Portugal

Location

CHBV - Hospital Infante D. Pedro

Aveiro, 3810-501, Portugal

Location

CHL - Hospital Santo Andre

Leiria, 2410-197, Portugal

Location

ULSAM - Hospital Santa Luzia

Viana do Castelo, 4901-858, Portugal

Location

Russian Scientific Center n.a. acad. G.A. Ilizarov

Kurgan, 640014, Russia

Location

Privolzhskiy Federal Medical Research Center

Nizhny Novgorod, 603155, Russia

Location

City Hospital #2

Saint Petersburg, 194354, Russia

Location

Sci-Res. Institute of Traumatology and Orthopaedia

Saint Petersburg, 195427, Russia

Location

Clinical Hospital for Emergency Care n.a. N.V.Solovyov

Yaroslavl, 150003, Russia

Location

Pretoria Academic Hospital New

Pretoria, Gauteng, 0084, South Africa

Location

UCT Clinical Research Centre

Cape Town, Western Cape, South Africa

Location

Clinical Projects Research SA

Worcester, Western Cape, 6850, South Africa

Location

Ciutat Sanitària i Universitària de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Fundación Hospital Alcorcón

Alcorcón, Madrid, 28922, Spain

Location

Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clínic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Complejo Hospitalario de Jaén

Jaén, 23009, Spain

Location

Hospital Clínico Universitario San Carlos

Madrid, 28040, Spain

Location

Cherkasy Reg Clinical Hospital of Cherkasy Reg Council

Cherkasy, 18009, Ukraine

Location

Ivano-Frankivsk Regional Clinical Hospital

Ivano-Frankivsk, 76008, Ukraine

Location

Kyiv Regional Clinical Hospital

Kyiv, 4107, Ukraine

Location

Related Publications (1)

• Weitz JI, Bauersachs R, Becker B, Berkowitz SD, Freitas MCS, Lassen MR, Metzig C, Raskob GE. Effect of Osocimab in Preventing Venous Thromboembolism Among Patients Undergoing Knee Arthroplasty: The FOXTROT Randomized Clinical Trial. JAMA. 2020 Jan 14;323(2):130-139. doi: 10.1001/jama.2019.20687.

  PMID: 31935028 DERIVED

Related Links

• Click here to find results for studies related to Bayer products

MeSH Terms

Conditions

Venous Thromboembolism; Venous Thrombosis

Interventions

Enoxaparin; apixaban; osocimab

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: September 8, 2017
• Study Start: September 21, 2017
• Primary Completion: August 20, 2018
• Study Completion: January 2, 2019
• Last Updated: March 3, 2020

Record last verified: 2020-02

Locations

LI (5); ES (6); UA (3); CA (1); GR (4); LA (4); BU (3); IL (5); PL (6); CZ (4); PT (5); RU (5); ZA (3)