aortic stenosis
Conditions
Interventions
Trade Name: Lixiana
Pharmaceutical Form: Film-coated tablet
Sponsors
Thoraxcentrum Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients completed successful elective TAVI for severe aortic valve stenosis with any commercially-available transcatheter heart valve (THV). o Correct positioning of a single prosthetic heart valve into the proper anatomical location o Device success, defined by ? Mean aortic valve gradient =65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: • History of life-threatening or major bleeding event = BARC 3b definitions within the last year • Other conditions with a high risk of bleeding o Active peptic ulcer or upper gastrointestinal bleeding within last 3 months prior to enrolment o Malignancy with high risk of bleeding o Recent unresolved brain of spinal injury o Spinal or ophthalmic surgery within last 3 months prior to enrolment o Intracranial haemorrhage o Esophagal varices o Atriovenous malformations with high risk of bleeding o Vascular aneurysms o Major intraspinal or intracerebral vascular abnormalities • Hypersensitivity or contraindications to edoxaban • Requirement for dual-antiplatelet therapy (DAPT) within 1 month prior to randomization. • Concomitant percutaneous coronary intervention (PCI) during the TAVI procedure, requiring DAPT after the procedure. • Renal impairment defined as by dialysis-dependency or GFR < 30 mL/min at time of enrollment • Active bleeding or bleeding diasthesis including thrombocytopenia (platelet count < 50.000 cells/UL), thrombobasthenia, haemophilia or von Willebrand disease • Patients unable to adhere to or complete the investigational protocol for any reason including but not limited to geographical residence, psychiatric condtition or life-threatening disease • Pregnant or breast-feeding subjects • Current participation in clinical trials that potentially interfere with the current study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether edoxaban affects the incidence of aortic valve leaflet thickening after TAVI as assessed by cardiac 4DCT-scan after 3 months treatment.;Secondary Objective: To investigate whether treatment with edoxaban affects transprosthetic gradients (i.e. change in transprosthetic gradient between TTE at discharge and at 1 year) after TAVI. And to investigate the effect on the incidence of stage =2 bioprosthetic valve dysfunction at 1 year as defined by the VARC-3 consensus. To investigate the safety of edoxaban treatment in patients undergoing TAVI -with no formal OAC indication- on net adverse clinical outcomes after 1 month, 3 months and one year; i.e.: the composite of all-cause death, myocardial infarction (MI), ischemic stroke, systemic thromboembolism, valve thrombosis and major bleeding (International Society on Thrombosis and Hemostasis [ISTH] definition) and every endpoint separately including any neurological event (minor/disabling stroke and TIA) To investigate the effect of edoxaban treatment in patients undergoing TAVI -with no formal OAC indication- on major bleeding at 1 month, 3 months and one year;Primary end point(s): incidence of aortic valve leaflet thickening after TAVI as assessed by cardiac 4DCT-scan after 3 months treatment;Timepoint(s) of evaluation of this end point: three months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): occurrence of reduced THV leaflet motion by MSCT at 3 months of follow up. transprosthetic gradients (i.e. change in transprosthetic gradient, effective orifice area and doppler velocity index between TTE at discharge and at 1 year) after TAVI. the occurrence and increase of aortic regurgitation as determined by transthoracic echocardiography pre-discharge and at 12 months. the composite of all-cause death, myocardial infarction (MI), ischemic stroke, systemic thromboembolism, valve thrombosis and major bleeding (International Society on Thrombosis and Hemostasis [ISTH] definition) and every endpoint separately including any neurological event (minor/disabling stroke and TIA) To investigate the effect of edoxaban treatment in patients undergoing TAVI -with no formal OAC indication- on major bleeding at 1 month, 3 months and one year;Timepoint(s) of evaluation of this end point: one month, 3 months and 12 months | — |
Countries
Netherlands
Contacts
Public ContactPrincipal Investigator
Thoraxcentrum Erasmus MC
Outcome results
None listed