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

NCT03284827 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2021-11-08

No results posted yet for this study

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

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

Sponsors & Collaborators

  • CardioVascular Research Foundation, Korea

    collaborator OTHER

  • Daiichi Sankyo Korea Co., Ltd.

    collaborator INDUSTRY

  • Duk-Woo Park, MD

    lead OTHER

Principal Investigators

  • Seung-jung Park, MD · Cardiology, Asan Medical Center Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-15
Primary Completion
2021-10-26
Completion
2021-11-05

Countries

  • Hong Kong
  • South Korea
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03284827 on ClinicalTrials.gov