NCT07753200

Brief Summary

Non-vitamin K antagonist oral anticoagulants(NOACs) are standard care for thromboembolism prevention in patients with Aterial Fibrillation(AF). However, evidence comparing edoxaban and apixaban remains limited in AF patients with coexisting coronary artery disease(CAD). This study aims to evaluate whether edoxaban-based therapy is non-interior to apixaban-based therapy with respect to Net Adverse Clinical Events(NACE) in AF patients with concomitant CAD.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for phase_4

Timeline
63mo left

Started Jul 2026

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Jul 2026Dec 2031

Study Start

First participant enrolled

July 20, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 31, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2026

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2031

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

August 10, 2026

Status Verified

August 1, 2026

Enrollment Period

4.9 years

First QC Date

July 31, 2026

Last Update Submit

August 6, 2026

Conditions

Atrial Fibrillation (AF)Coronary Arterial Disease (CAD)

Outcome Measures

Primary Outcomes (1)

  • Net Adverse Clinical Events (NACE)

    A composite of death from any causes, Myocardial Infarction, Stroke, systemic embolic events or International Society on Thrombosis and Hemostasis major bleeding

    5 years

Secondary Outcomes (1)

  • Major Adverse Cardiovascular and Cerebrovascular Events (MACEE)

    5 years

Study Arms (2)

Edoxaban-based treatment group

EXPERIMENTAL

Edoxaban 60mg once daily orally, continue until follow-up is complete.

Drug: Edoxaban

Apixaban-based treatment group

ACTIVE COMPARATOR

Apixaban 5mg twice a day orally, continue until follow-up is complete.

Drug: Apixaban

Interventions

EdoxabanDRUG

Edoxaban 60mg will be administered once daily orally according to the study protocol.

Also known as: Lixiana
Edoxaban-based treatment group
ApixabanDRUG

Apixaban 5mg will be administered twice a day orally according to the study protocol.

Also known as: Eliquis
Apixaban-based treatment group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must be at least 19 years of age
  • Patients with AF requiring oral anticoagulation therapy (CHA2DS2-VaSc 2 or more)
  • Documented coronary artery disease, defined as at least one of the following: history of percutaneous coronary intervention (PCI), history of coronary artery bypass grafting (CABG), major epicardial coronary artery stenosis ≥50% on coronary computed tomography angiography (CCTA) or invasive coronary angiography
  • Patients who can understand risks, benefits and treatment alternatives and sign informed consent voluntarily.

You may not qualify if:

  • Known hypersensitivity or contraindications to study medications (apixaban or edoxaban)
  • Severe renal impairment (creatinine clearance \<15 mL/min) or dialysis
  • Active major bleeding
  • Indication requiring alternative anticoagulation (e.g., mechanical valve surgery or moderate / severe mitral stenosis)
  • Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

edoxabanapixaban

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Joo-yong Hahn, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joo-Yong Hahn, MD, PhD

CONTACT

82-2-3410-6653Jooyong.hahn@gmail.com

Ki-Hong Choi, MD, PhD

CONTACT

82-2-3410-6653cardiokh@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 31, 2026

First Posted

August 7, 2026

Study Start

July 20, 2026

Primary Completion (Estimated)

June 1, 2031

Study Completion (Estimated)

December 31, 2031

Last Updated

August 10, 2026

Record last verified: 2026-08

Locations

KR(1)