Anticoagulant versus Dual Antiplatelet Therapy for Preventing Leaflet Thrombosis and Cerebral Embolization After Transcatheter Aortic Valve Replacement
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0003003
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Anticoagulant versus Dual Antiplatelet Therapy for Preventing Leaflet Thrombosis and Cerebral Embolization After Transcatheter Aortic Valve Replacement
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 229
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 Valve Academic Research Consortium (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
1.Any atrial fibrillation with an indication for chronic OAC(Oral anticoagulant)
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 and/or Cardiac CT (e.g., tremor from Parkinson’s disease) This is at the discretion of investigators
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method an incidence of leaflet thrombosis on four-dimensional, volume-rendered cardiac CT imaging
- Secondary Outcome Measures
Name Time Method The number of new lesions on brain DW-MRI scans at 6 months relative to immediate post-TAVR;New lesion volume on MRI scans;Neurological and neurocognitive function;The change of Echocardiographic parameter : the mean transaortic valve pressure gradient and velocity time integral ratio at baseline and 6-month follow-up;All-cause death;Myocardial infarction;Stroke or transient ischemic attack;life-threatening or disabling, major bleeding, or minor bleeding