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Edoxaban Versus Edoxaban With antiPlatelet Agent In Patients With Atrial Fibrillation and Chronic Stable Coronary Artery Disease

NCT03718559 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1040

Last updated 2024-06-10

No results posted yet for this study

Summary

This study evaluates the efficacy and safety of Edoxaban with the combination of edoxaban and antiplatelet in patients with stable CAD (coronary artery stenosis ≥50% on medical treatment or revascularized stable CAD \[≥ 12 months for acute coronary syndrome and ≥ 6 months after stable CAD\]) and high-risk atrial fibrillation (CHA2DS2-VASc score ≥2).

Conditions

Interventions

DRUG

Edoxaban Monotherapy

Taking edoxaban (Lixiana™, Daiichi-Sankyo Inc.) 60mg once daily. The dose of edoxaban will be reduced to 30mg once daily in patients with estimated creatinine clearance 15≤CrCL≤50mL/min by Cockcroft-Gault equation or weight is ≤60kg.

DRUG

Edoxaban plus Single Antiplatelet Agent

Type of antiplatelet agent is dependant upon the investigator's discretion, but aspirin 100mg once daily or clopidogrel 75mg once daily was recommended.

Sponsors & Collaborators

  • CardioVascular Research Foundation, Korea

    collaborator OTHER

  • Gi-Byoung Nam

    lead OTHER

Principal Investigators

  • Duk-woo Park, MD · Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-14
Primary Completion
2023-11-08
Completion
2023-11-08

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 NCT03718559 on ClinicalTrials.gov