NCT03284827

Anticoagulant Versus Dual Antiplatelet Therapy for Preventing Leaflet Thrombosis and Cerebral Embolization After Transcatheter Aortic Valve Replacement

a Multicenter, Randomized, Open-label, Active-treatment, Controlled Trial to Compare the Efficacy of NOAC With Edoxaban vs. Dual Antiplatelet Therapy (DAPT) for Prevention of Leaflet Thrombosis (Documented by Cardiac CT Imaging) and Cerebral Embolization (Documented With Brain DW-MRI Imaging) in Patients Without an Absolute Indication for Chronic OAC After Successful TAVR

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 235 (actual)
• Sponsor: Duk-Woo Park, MD · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DRUG	NOAC	edoxaban (60 mg once daily \[OD\]) for at least 6 months
DRUG	DAPT	clopidogrel (75 mg OD) plus acetylsalicylic acid (ASA, 75-100 mg OD) for at least 6 months

Timeline

• Start date: 2018-03-15
• Primary completion: 2021-10-26
• Completion: 2021-11-05
• First posted: 2017-09-15
• Last updated: 2021-11-08

Locations

5 sites across 3 countries: Hong Kong, South Korea, Taiwan