CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,040 enrolled
Drug / intervention
Edoxaban Monotherapy +1 moredrug
Likely dose
Edoxaban Monotherapy 60mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03718559
NCT03718559Phase 4Completed
CompareCT.gov

A Multi-centre, Open-labelled, Randomized Controlled Trial Comparing Two Different Anticoagulation Strategies in High-risk Atrial Fibrillation and Stable Coronary Artery Disease

Gi-Byoung Nam·interventional·Posted Oct 24, 2018·Updated Jun 10, 2024

In Brief

A Phase 4 clinical trial evaluating Edoxaban Monotherapy and Edoxaban plus Single Antiplatelet Agent for Atrial Fibrillation and 3 related conditions. Completed, enrolled 1,040 participants across 18 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Coronary Artery Disease, Stable Angina, Stable Chronic Angina
CountriesSouth Korea
CollaboratorsCardioVascular Research Foundation, Korea

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedOct 24, 2018
Enrollment StartMay 14, 2019
Primary CompletionNov 8, 2023
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 7.7 years ago

Interventions

Edoxaban Monotherapydrug

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.

Edoxaban plus Single Antiplatelet Agentdrug

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