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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
235
Queen Mary Hospital
Hong Kong, Hong Kong
Asan Medical Center
Seoul, Songpa-gu, South Korea
Bundang CHA Hospital
Seongnam, South Korea
Cheng Hsin General Hospital
Taipei, Taiwan
National Taiwan University Hospital
an incidence of leaflet thrombosis
an incidence of leaflet thrombosis on four-dimensional, volume-rendered cardiac CT imaging
Time frame: 6-month
Death
all-cause, cardiovascular, or non-cardiovascular mortality
Time frame: 6-month
Myocardial infarction
Time frame: 6-month
Stroke or transient ischemic attack
disabling or non-disabling
Time frame: 6-month
Bleeding event
life-threatening or disabling, major bleeding, or minor bleeding according to VARC(The Valve Academic Research Consortium)-2 definition
Time frame: 6-month
The change of Echocardiographic parameter
the mean transaortic valve pressure gradient and velocity time integral ratio at baseline and 6-month follow-up
Time frame: 6-month
New lesion volume on MRI scans
Time frame: 6-month
The change of neurological and neurocognitive function
according to NeuroARC(Neuro Academic Research Consortium) definition
Time frame: 6-month
the number of new lesions on brain DW-MRI scans
the number of new lesions on brain DW-MRI scans at 6 months relative to immediate post-TAVR
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Taipei, Taiwan
Time frame: 6-month