A Phase 4 interventional study of NOAC and DAPT in Aortic Valve Stenosis, sponsored by Duk-Woo Park, MD. Completed at 5 sites in 3 countries. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2021-11-08.
Sponsored by Duk-Woo Park, MD · Phase 4, Interventional, and Prevention
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).
Patients 19 years of age or older with successful TAVR procedure
A successful TAVR is defined as device success according to the VARC-2 criteria:
Exclusion Criteria:
60 mg once daily
Drug: NOAC
clopidogrel (75 mg OD) plus acetylsalicylic acid (ASA, 75-100 mg OD)
Drug: DAPT
edoxaban (60 mg once daily \[OD\]) for at least 6 months
clopidogrel (75 mg OD) plus acetylsalicylic acid (ASA, 75-100 mg OD) for at least 6 months
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
Time frame: 6-month
Plan to share: Undecided
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Duk-Woo Park, MD