Trial Condition(s):

Knee Arthroplasty, Total

FactOr XIa inhibiTion for the pRevention of venOus Thromboembolism in patients undergoing total knee arthroplasty (FOXTROT)

Bayer Identifier:

17664

ClinicalTrials.gov Identifier:

NCT03276143

EudraCT Number:

2016-002681-31

Study Completed

Trial Purpose

This study is to compare the study drug BAY1213790 to existing therapies, ie Enoxaparin or Apixaban for the prevention of blood clotting and safety in patients undergoing total knee arthroplasty (TKA). The study is open-label, but observer-blind for the different doses of BAY1213790 administered. This means that it is known which treatment is given, but it is not known which dose of BAY1213790 is administered.

Inclusion Criteria
- Patients aged ≥18 years undergoing elective primary, unilateral TKA
For women,
- Women of non-childbearing potential
Exclusion Criteria
- High risk for clinically significant bleeding
- Prior deep vein thrombosis
- Creatinine clearance below 60 ml/min
- Active cancer except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been curatively treated
- Contraindication listed in the local label of the comparator treatments
- Requirement for full dose anticoagulation or dual antiplatelet therapy (low dose of acetylsalicylic acid is allowed)

Trial Summary

Enrollment Goal
791
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
BAY1213790
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Konstantopoulio General Hospital of Nea Ionia - Agia Olga

Nea Ionia, Greece, 14233

Status
Completed
 
Locations

KAT General Hospital of Athens

Kifisia, Greece, 14561

Status
Completed
 
Locations

Papageorgiou General Hospital of Thessaloniki

Thessaloniki, Greece, 56403

Status
Completed
 
Locations

UMHAT Sveti Georgi

Plovdiv, Bulgaria, 4002

Status
Completed
 
Locations

Acibadem City Clinic Multiprofile Hospital for Active Treatm

Sofia, Bulgaria, 1407

Status
Completed
 
Locations

UMHAT Tsaritsa Joanna-ISUL EAD Sofia

Sofia, Bulgaria, 1527

Status
Completed
 
Locations

Lithuanian university of Health science

Kaunas, Lithuania, LT-50009

Status
Completed
 
Locations

Kaunas clinical hospital (Laisves ave.)

Kaunas, Lithuania, LT-44320

Status
Completed
 
Locations

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania, LT-08661

Status
Completed
 
Locations

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, Poland, 15-276

Status
Completed
 
Locations

Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

Lodz, Poland, 92-213

Status
Completed
 
Locations

Wojewodzki Szpital Specjalistyczny im. Rydygiera

Krakow, Poland, 31-826

Status
Completed
 
Locations

Uniwersytecki Szpital Kliniczny UM we Wroclawiu

Wroclaw, Poland, 50-556

Status
Completed
 
Locations

Wojewódzki Szpital Zespolony

Kielce, Poland

Status
Completed
 
Locations

Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZ

Lublin, Poland, 20-718

Status
Completed
 
Locations

Nemocnice Ceske Budejovice, a.s.

Ceske Budejovice, Czech Republic, 370 87

Status
Completed
 
Locations

Regional Hospital Pardubice

Pardubice, Czech Republic, 530 03

Status
Completed
 
Locations

Okresni nemocnice Jindrichuv Hradec

Jindrichuv Hradec, Czech Republic, 377 38

Status
Completed
 
Locations

Rambam Health Corporation

Haifa, Israel, 3109601

Status
Completed
 
Locations

Clalit Health Services through Rabin Medical Center - Beilinson Campus

Petah Tikva, Israel, 4941492

Status
Completed
 
Locations

Meir Medical Center

Kfar-Saba, Israel, 4428164

Status
Completed
 
Locations

Kaplan Medical Center

Rehovot, Israel, 7610001

Status
Completed
 
Locations

Lady Davis Carmel Medical Center

Haifa, Israel, 3436212

Status
Completed
 
Locations

Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

Status
Completed
 
Locations

Hospital Clínico Universitario San Carlos

Madrid, Spain, 28040

Status
Completed
 
Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

Status
Completed
 
Locations

Fundación Hospital Alcorcón

Alcorcón, Spain, 28922

Status
Completed
 
Locations

Ciutat Sanitària i Universitària de Bellvitge

L'Hospitalet de Llobregat, Spain, 08907

Status
Completed
 
Locations

Clinical Projects Research SA

Worcester, South Africa, 6850

Status
Completed
 
Locations

UCT Clinical Research Centre

Cape Town, South Africa

Status
Completed
 
Locations

Pretoria Academic Hospital New

Pretoria, South Africa, 0084

Status
Completed
 
Locations

Kyiv Regional Clinical Hospital

Kyiv, Ukraine, 4107

Status
Completed
 
Locations

Cherkasy Reg Clinical Hospital of Cherkasy Reg Council

Cherkasy, Ukraine, 18009

Status
Completed
 
Locations

Ivano-Frankivsk Regional Clinical Hospital

Ivano-Frankivsk, Ukraine, 76008

Status
Completed
 
Locations

Medical Investigative & Clinical Evaluation Inc.

Windsor, Canada, N8W 1E6

Status
Completed
 
Locations

Valmiera Hospital

Valmiera, Latvia, LV-4201

Status
Completed
 
Locations

Privolzhskiy Federal Medical Research Center

Nizhny Novgorod, Russia, 603155

Status
Completed
 
Locations

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

Kurgan, Russia, 640014

Status
Completed
 
Locations

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

Yaroslavl, Russia, 150003

Status
Completed
 
Locations

Liepaja Regional Hospital

Liepaja, Latvia, LV-3414

Status
Completed
 
Locations

Riga 2nd City Hospital

Riga, Latvia, LV-1004

Status
Completed
 
Locations

Hospital of Traumatology and Orthopaedics

Riga, Latvia, LV–1005

Status
Completed
 
Locations

Sci-Res. Institute of Traumatology and Orthopaedia

St. Petersburg, Russia, 195427

Status
Completed
 
Locations

City Hospital #2

St. Petersburg, Russia, 194354

Status
Completed
 
Locations

University General Hospital of Patras

Rio / Patras, Greece, 265 04

Status
Completed
 
Locations

PI Klaipedos University Hospital

Klaipeda, Lithuania, LT-92288

Status
Completed
 
Locations

Republican Vilnius University Hospital

Vilnius, Lithuania, LT-04130

Status
Completed
 
Locations

CHS - Hospital Ortopedico Sant Iago do Outao

Setubal, Portugal, 2900-182

Status
Completed
 
Locations

CHBV - Hospital Infante D. Pedro

Aveiro, Portugal, 3810-501

Status
Completed
 
Locations

Hospital de Cascais

Alcabideche, Portugal, 2755-009

Status
Completed
 
Locations

CHL - Hospital Santo Andre

Leiria, Portugal, 2410-197

Status
Completed
 
Locations

Complejo Hospitalario de Jaén

Jaén, Spain, 23009

Status
Completed
 
Locations

ULSAM - Hospital Santa Luzia

Viana do Castelo, Portugal, 4901-858

Status
Completed
 
Locations

Fakultni nemocnice u sv. Anny

Brno, Czech Republic, 656 91

Status
Completed
 

Trial Design