NCT03718559

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,040 (actual)
• Sponsor: Gi-Byoung Nam · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Atrial Fibrillation
• Coronary Artery Disease
• Stable Angina
• Stable Chronic Angina

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-05-14
• Primary completion: 2023-11-08
• Completion: 2023-11-08
• First posted: 2018-10-24
• Last updated: 2024-06-10

Locations

18 sites across 1 country: South Korea