check_circleStudy Completed

Knee Arthroplasty, Total

Bayer Identifier:

17664

ClinicalTrials.gov Identifier:

NCT03276143

EudraCT Number:

2016-002681-31

EU CT Number:

Not Available
FactOr XIa inhibiTion for the pRevention of venOus Thromboembolism in patients undergoing total knee arthroplasty

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - Patients aged ≥18 years undergoing elective primary, unilateral TKA
    For women,
    - Women of non-childbearing potential

  • - 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
September 2017 - January 2019
Phase
Phase 2
Could I Receive a placebo
No
Products
BAY1213790
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Konstantopoulio General Hospital of Nea Ionia - Agia OlgaNea Ionia, 14233, Greece
Completed
KAT General Hospital of AthensKifisia, 14561, Greece
Completed
KAT General Hospital of AthensKifisia, 14561, Greece
Completed
Papageorgiou General Hospital of ThessalonikiThessaloniki, 56403, Greece
Completed
UMHAT Sveti GeorgiPlovdiv, 4002, Bulgaria
Withdrawn
UMHATEM N. I. Pirogov EADSofia, 1606, Bulgaria
Completed
Acibadem City Clinic Multiprofile Hospital for Active TreatmSofia, 1407, Bulgaria
Completed
UMHAT Tsaritsa Joanna-ISUL EAD SofiaSofia, 1527, Bulgaria
Completed
Lithuanian university of Health scienceKaunas, LT-50009, Lithuania
Completed
Kaunas clinical hospital (Laisves ave.)Kaunas, LT-44320, Lithuania
Completed
Vilnius University Hospital Santaros KlinikosVilnius, LT-08661, Lithuania
Completed
Uniwersytecki Szpital Kliniczny w BialymstokuBialystok, 15-276, Poland
Completed
Centralny Szpital Kliniczny Uniwersytetu Medycznego w LodziLodz, 92-213, Poland
Completed
Wojewodzki Szpital Specjalistyczny im. RydygieraKrakow, 31-826, Poland
Completed
Uniwersytecki Szpital Kliniczny UM we WroclawiuWroclaw, 50-556, Poland
Completed
Wojewódzki Szpital ZespolonyKielce, Poland
Completed
Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZLublin, 20-718, Poland
Completed
Nemocnice Ceske Budejovice, a.s.Ceske Budejovice, 370 87, Czech Republic
Withdrawn
Nemocnice Nove Mesto na MoraveNove Mesto na Morave, 592 31, Czech Republic
Completed
Regional Hospital PardubicePardubice, 530 03, Czech Republic
Completed
Okresni nemocnice Jindrichuv HradecJindrichuv Hradec, 377 38, Czech Republic
Completed
Rambam Health CorporationHaifa, 3109601, Israel
Completed
Clalit Health Services through Rabin Medical Center - Beilinson CampusPetah Tikva, 4941492, Israel
Completed
Meir Medical CenterKfar-Saba, 4428164, Israel
Completed
Kaplan Medical CenterRehovot, 7610001, Israel
Completed
Lady Davis Carmel Medical CenterHaifa, 3436212, Israel
Completed
Ciutat Sanitària i Universitaria de la Vall d'HebronBarcelona, 08035, Spain
Completed
Hospital Clínico Universitario San CarlosMadrid, 28040, Spain
Completed
Hospital Clínic i Provincial de BarcelonaBarcelona, 08036, Spain
Completed
Fundación Hospital AlcorcónAlcorcón, 28922, Spain
Completed
Ciutat Sanitària i Universitària de BellvitgeL'Hospitalet de Llobregat, 08907, Spain
Completed
Clinical Projects Research SAWorcester, 6850, South Africa
Completed
UCT Clinical Research CentreCape Town, South Africa
Withdrawn
TREAD Research ccCape Town, 7500, South Africa
Completed
Pretoria Academic Hospital NewPretoria, 0084, South Africa
Withdrawn
Fakultni nemocnice BrnoBrno, 625 00, Czech Republic
Completed
Kyiv Regional Clinical HospitalKyiv, 4107, Ukraine
Completed
Cherkasy Reg Clinical Hospital of Cherkasy Reg CouncilCherkasy, 18009, Ukraine
Completed
Ivano-Frankivsk Regional Clinical HospitalIvano-Frankivsk, 76008, Ukraine
Withdrawn
Hopital Jean TalonMontreal, H2E 1S6, Canada
Completed
Medical Investigative & Clinical Evaluation Inc.Windsor, N8W 1E6, Canada
Completed
Valmiera HospitalValmiera, LV-4201, Latvia
Completed
Privolzhskiy Federal Medical Research CenterNizhny Novgorod, 603155, Russia
Completed
Russian Scientific Center n.a. acad. G.A. IlizarovKurgan, 640014, Russia
Completed
Clinical Hospital for Emergency Care n.a. N.V.SolovyovYaroslavl, 150003, Russia
Completed
Liepaja Regional HospitalLiepaja, LV-3414, Latvia
Completed
Riga 2nd City HospitalRiga, LV-1004, Latvia
Completed
Hospital of Traumatology and OrthopaedicsRiga, LV–1005, Latvia
Completed
Sci-Res. Institute of Traumatology and OrthopaediaSt. Petersburg, 195427, Russia
Completed
City Hospital #2St. Petersburg, 194354, Russia
Withdrawn
Clinical Hospital #122 n.a. L.G. SokolovSt. Petersburg, 194291, Russia
Completed
University General Hospital of PatrasRio / Patras, 265 04, Greece
Completed
PI Klaipedos University HospitalKlaipeda, LT-92288, Lithuania
Completed
Republican Vilnius University HospitalVilnius, LT-04130, Lithuania
Completed
CHS - Hospital Ortopedico Sant Iago do OutaoSetubal, 2900-182, Portugal
Completed
CHBV - Hospital Infante D. PedroAveiro, 3810-501, Portugal
Completed
Hospital de CascaisAlcabideche, 2755-009, Portugal
Completed
CHL - Hospital Santo AndreLeiria, 2410-197, Portugal
Completed
Complejo Hospitalario de JaénJaén, 23009, Spain
Withdrawn
UMHAT Kanev ADRuse, 7002, Bulgaria
Completed
ULSAM - Hospital Santa LuziaViana do Castelo, 4901-858, Portugal
Withdrawn
Fakultni Nemocnice Hradec KraloveHradec Kralove, 500 05, Czech Republic
Completed
Fakultni nemocnice u sv. AnnyBrno, 656 91, Czech Republic

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 excluded
    DVT: deep vein thrombosis PE: pulmonary embolism All suspected events will be reviewed and classified by the Central Independent Adjudication Committee
    date_rangeTime Frame:
    up to Visit 7 (Day 12+3)
  • Incidence of composite endpoint of major and clinically relevant non-major bleeding
    All suspected events will be reviewed and classified by the Central Independent Adjudication Committee
    date_rangeTime Frame:
    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 12
    All suspected events will be reviewed and classified by the Central Independent Adjudication Committee
    date_rangeTime Frame:
    up to Visit 10 (Day 150±7)
  • Incidence of composite endpoint of major and clinically relevant non-major bleeding
    All suspected events will be reviewed and classified by the Central Independent Adjudication Committee
    date_rangeTime Frame:
    up to Visit 10 (Day 150±7)

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

Additional Information

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