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:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Konstantopoulio General Hospital of Nea Ionia - Agia Olga Nea Ionia, Greece, 14233 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations KAT General Hospital of Athens Kifisia, Greece, 14561 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Papageorgiou General Hospital of Thessaloniki Thessaloniki, Greece, 56403 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UMHAT Sveti Georgi Plovdiv, Bulgaria, 4002 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Acibadem City Clinic Multiprofile Hospital for Active Treatm Sofia, Bulgaria, 1407 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UMHAT Tsaritsa Joanna-ISUL EAD Sofia Sofia, Bulgaria, 1527 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Lithuanian university of Health science Kaunas, Lithuania, LT-50009 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kaunas clinical hospital (Laisves ave.) Kaunas, Lithuania, LT-44320 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vilnius University Hospital Santaros Klinikos Vilnius, Lithuania, LT-08661 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Uniwersytecki Szpital Kliniczny w Bialymstoku Bialystok, Poland, 15-276 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi Lodz, Poland, 92-213 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Wojewodzki Szpital Specjalistyczny im. Rydygiera Krakow, Poland, 31-826 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Uniwersytecki Szpital Kliniczny UM we Wroclawiu Wroclaw, Poland, 50-556 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Wojewódzki Szpital Zespolony Kielce, Poland | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZ Lublin, Poland, 20-718 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nemocnice Ceske Budejovice, a.s. Ceske Budejovice, Czech Republic, 370 87 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Regional Hospital Pardubice Pardubice, Czech Republic, 530 03 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Okresni nemocnice Jindrichuv Hradec Jindrichuv Hradec, Czech Republic, 377 38 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Rambam Health Corporation Haifa, Israel, 3109601 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clalit Health Services through Rabin Medical Center - Beilinson Campus Petah Tikva, Israel, 4941492 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Meir Medical Center Kfar-Saba, Israel, 4428164 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kaplan Medical Center Rehovot, Israel, 7610001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Lady Davis Carmel Medical Center Haifa, Israel, 3436212 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ciutat Sanitària i Universitaria de la Vall d'Hebron Barcelona, Spain, 08035 | Status Completed | Contact Us: E-mail: cl[email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínico Universitario San Carlos Madrid, Spain, 28040 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08036 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fundación Hospital Alcorcón Alcorcón, Spain, 28922 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ciutat Sanitària i Universitària de Bellvitge L'Hospitalet de Llobregat, Spain, 08907 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Projects Research SA Worcester, South Africa, 6850 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UCT Clinical Research Centre Cape Town, South Africa | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Pretoria Academic Hospital New Pretoria, South Africa, 0084 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kyiv Regional Clinical Hospital Kyiv, Ukraine, 4107 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cherkasy Reg Clinical Hospital of Cherkasy Reg Council Cherkasy, Ukraine, 18009 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ivano-Frankivsk Regional Clinical Hospital Ivano-Frankivsk, Ukraine, 76008 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medical Investigative & Clinical Evaluation Inc. Windsor, Canada, N8W 1E6 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Valmiera Hospital Valmiera, Latvia, LV-4201 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Privolzhskiy Federal Medical Research Center Nizhny Novgorod, Russia, 603155 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Russian Scientific Center n.a. acad. G.A. Ilizarov Kurgan, Russia, 640014 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Hospital for Emergency Care n.a. N.V.Solovyov Yaroslavl, Russia, 150003 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Liepaja Regional Hospital Liepaja, Latvia, LV-3414 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Riga 2nd City Hospital Riga, Latvia, LV-1004 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital of Traumatology and Orthopaedics Riga, Latvia, LV–1005 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sci-Res. Institute of Traumatology and Orthopaedia St. Petersburg, Russia, 195427 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations City Hospital #2 St. Petersburg, Russia, 194354 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University General Hospital of Patras Rio / Patras, Greece, 265 04 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations PI Klaipedos University Hospital Klaipeda, Lithuania, LT-92288 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Republican Vilnius University Hospital Vilnius, Lithuania, LT-04130 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHS - Hospital Ortopedico Sant Iago do Outao Setubal, Portugal, 2900-182 | Status Completed | Contact Us: E-mail: clinical-tria[email protected] Phone: (+)1-888-84 22937 |
Locations CHBV - Hospital Infante D. Pedro Aveiro, Portugal, 3810-501 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital de Cascais Alcabideche, Portugal, 2755-009 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHL - Hospital Santo Andre Leiria, Portugal, 2410-197 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Complejo Hospitalario de Jaén Jaén, Spain, 23009 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ULSAM - Hospital Santa Luzia Viana do Castelo, Portugal, 4901-858 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice u sv. Anny Brno, Czech Republic, 656 91 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
A randomized, active-comparator-controlled, multicenter study to assess the safety and efficacy of different doses of BAY1213790 for the prevention of venous thromboembolism in patients undergoing elective primary total knee arthroplasty, open-label to treatment and observer-blinded to BAY1213790 doses
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- 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 excludedDVT: deep vein thrombosis PE: pulmonary embolism All suspected events will be reviewed and classified by the Central Independent Adjudication CommitteeTimeframe: up to Visit 7 (Day 12+3)
- Incidence of composite endpoint of major and clinically relevant non-major bleedingAll suspected events will be reviewed and classified by the Central Independent Adjudication CommitteeTimeframe: up to Visit 7 (Day 12+3)
Secondary Outcome
- Incidence of composite endpoint of symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded up to Day 150 or objectively confirmed asymptomatic DVT up to day 12All suspected events will be reviewed and classified by the Central Independent Adjudication CommitteeTimeframe: up to Visit 10 (Day 150±7)
- Incidence of composite endpoint of major and clinically relevant non-major bleedingAll suspected events will be reviewed and classified by the Central Independent Adjudication CommitteeTimeframe: up to Visit 10 (Day 150±7)
Additional Information
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