Aortic Valve Stenosis
Conditions
Keywords
edoxaban, dual antiplatelet therapy, cerebral embolization, leaflet thrombosis
Brief summary
This trial is to compare the efficacy of NOAC(Novel Oral Anticoagulants) with edoxaban vs. dual antiplatelet therapy (DAPT) for prevention of leaflet thrombosis (documented by cardiac CT imaging) and cerebral embolization (documented with brainDiffusion-weighted (DW) magnetic resonance (MR) imaging) in patients without an absolute indication for chronic oral anticoagulation (OAC) after successful transcatheter aortic valve replacement(TAVR).
Interventions
Sponsors
CardioVascular Research Foundation, Korea
Daiichi Sankyo Korea Co., Ltd.
Duk-Woo Park, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients 19 years of age or older with successful TAVR procedure * either native valve or valve-in-valve with any approved/marketed device * A successful TAVR is defined as device success according to the VARC-2 criteria: 1. correct positioning of a single prosthetic heart valve into the proper anatomical location AND 2. Intended performance of the prosthetic heart valve (no prosthesis- patient mismatch\* and mean aortic valve gradient \<20 mmHg or peak velocity \<3 m/s, no moderate or severe prosthetic valve regurgitation AND 3. absence of periprocedural complications (any type of stroke, life-threatening bleeding, acute coronary artery obstruction requiring intervention, major vascular complication requiring intervention, unresolved acute valve thrombosis, or any requirement of a repeat procedure. 2. Patients who voluntarily participated in the written agreement
Exclusion criteria
1. Any atrial fibrillation with an indication for chronic OAC. 2. An ongoing indication for OAC or any other indication for continued treatment with any OAC 3. Any ongoing indication for DAPT (recent acute coronary syndrome or PCI within 12 months) 4. Planned coronary or vascular intervention or major surgery 5. Clinically significant bleeding patients 6. The risk of bleeding increased due to the following reasons at the time of TAVR procedure, i. history of gastrointestinal ulcers within 1 month ii. Malignant tumor with high risk of bleeding iii. Brain or spinal cord injury within 1 month iv. History of intracranial or intracerebral hemorrhage within 12 months v. Esophageal varices vi. Arteriovenous malformation vii. Vascular aneurysms viii. Spinal cord vascular abnormalities or intracerebral vascular abnormalities ix. Active bleeding x. Hemoglobin level \<7.0 g/dL or platelet count ≤ 50,000 / mm3 xi. History of major surgery within 1 month 7. Clinically overt stroke within the last 3 months 8. Moderate and severe hepatic impairment, and any hepatic disease associated with coagulopathy 9. Severe renal impairment (CrCl by Cockcroft-Gault equation\<15 mL/min per 1.73 m2), chronic dialysis, or post-TAVR unresolved acute kidney injury 10. Terminal illness with life expectancy \<6 months 11. Hypersensitivity to the main component or constituents of Edoxaban 12. Severe hypertensive patient 13. Patient who received prosthetic heart valve replacement for which anticoagulant therapy is essential 14. Moderate to severe mitral stenosis 15. Pulmonary embolism requiring thrombolysis or pulmonary embolectomy 16. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period 17. Pregnancy test results are positive (all pregnant women should undergo urinary human chorionic gonadotropin (hCG) testing within 7 days prior to screening and / or randomization) or during pregnancy or lactation 18. Genetic problem with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption 19. History of hypersensitivity to Edoxaban, Aspirin or clopidogrel 20. Current or history of Aspirin- or NSAIDs-induced asthma 21. Hemophilia 22. Patients who are using Methotrexate at doses of 15mg or more per week 23. Patients who have unsuitable condition to undergo Brain MRI(Magnetic resonance imaging) and/or Cardiac CT(computed tomography) (e.g., tremor from Parkinson's disease). This is at the discretion of investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| an incidence of leaflet thrombosis | 6-month | an incidence of leaflet thrombosis on four-dimensional, volume-rendered cardiac CT imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial infarction | 6-month | — |
| Stroke or transient ischemic attack | 6-month | disabling or non-disabling |
| Bleeding event | 6-month | life-threatening or disabling, major bleeding, or minor bleeding according to VARC(The Valve Academic Research Consortium)-2 definition |
| Death | 6-month | all-cause, cardiovascular, or non-cardiovascular mortality |
| New lesion volume on MRI scans | 6-month | — |
| The change of neurological and neurocognitive function | 6-month | according to NeuroARC(Neuro Academic Research Consortium) definition |
| the number of new lesions on brain DW-MRI scans | 6-month | the number of new lesions on brain DW-MRI scans at 6 months relative to immediate post-TAVR |
| The change of Echocardiographic parameter | 6-month | the mean transaortic valve pressure gradient and velocity time integral ratio at baseline and 6-month follow-up |
Countries
Hong Kong, South Korea, Taiwan
Outcome results
None listed