MedTrace Logo

Resolution of Thrombi in Left Atrial Appendage With Edoxaban

NCT03840291 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-08-19

No results posted yet for this study

Summary

Non-valvular (NV) atrial fibrillation (AF) increases the risk of stroke by approximately fivefold. The atrial thrombi associated with AF are seen within the left atrial appendage (LAA) in most cases (\> 90%). Anticoagulation with a vitamin-K antagonist (VKA) is recommended to prevent thromboembolic complications and to resolve thrombi. Non-VKA oral anticoagulants (NOACs) have replaced the VKA for the thromboprophylaxis in patients with NVAF since 2010. Therefore, NOAC can be the excellent alternative to VKA concerning resolving preexisting LAA thrombi because of its rapid onset of action and no need of bridging with heparin. However, there is still lack of data regarding the optimal treatment for patients with AF and thrombi in LAA with NOAC. There are only several case reports of the efficacy of NOACs in resolving LAA thrombi available.

Edoxaban, which has data showing efficacy and safety in thromboprophylaxis, can be the new option for treatment of patients with AF and LAA thrombi. The purpose of this study is to evaluate the efficacy of Edoxaban in resolving the LAA thrombi, which is related with nonvalvular AF.

Conditions

Interventions

DRUG

Edoxaban

Edoxaban will be used for resolution of left atrial appendage thrombi

Sponsors & Collaborators

  • Daiichi Sankyo Korea Co., Ltd., a Daiichi Sankyo Company

    collaborator INDUSTRY

  • Keimyung University Dongsan Medical Center

    lead OTHER

Principal Investigators

  • Seongwook Han, M.D., Ph.D. · Keimyung University Dongsan Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-19
Primary Completion
2023-10-30
Completion
2024-08-01

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT03840291 on ClinicalTrials.gov