Atrial Fibrillation (AF)Phase 4SMARTDECISION3NCT07753200
Net Clinical Benefit of Edoxaban Versus Apixaban in Patients With Atrial Fibrillation and Coronary Artery Disease
A Phase 4 study testing Edoxaban and Apixaban in people with Atrial Fibrillation (AF) and Coronary Arterial Disease (CAD), run by Samsung Medical Center at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Coronary Arterial Disease (CAD)
- What is being tested?
- Edoxaban and Apixaban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jul 2026to 31 Dec 2031
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Jooyong Hahn, +82 02-3410-6653, mijin.eom@sbri.co.kr
About this study
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.
Read the detailed description
Non-vitamin K antagonist oral anticoagulants (NOACs) have become the standard of care for the prevention of thromboembolic events in patients with AF. In patients with AF and concomitant CAD, the choice of oral anticoagulant is particularly important because clinicians must balance the risks of thromboembolism, coronary ischemic events, as well as bleeding. Among available NOACs, apixaban and edoxaban share a common mechanism of factor Xa inhibition but differ substantially in dosing regimen, pharmacokinetic profile, and degree of renal elimination. In the recent COBRRA trial, apixaban was associated with significantly lower clinically relevant bleeding compared with rivaroxaban in patients with acute venous thromboembolism, without compromising efficacy against recurrent thromboembolism. Although these data support apixaban as an important benchmark NOAC, direct randomized comparisons between edoxaban and apixaban are lacking, particularly in patients with AF and coexisting CAD. Once-daily dosing and lower renal elimination fraction of edoxaban may offer practical advantages, particularly in elderly patients or those with impaired renal function, by potentially improving adherence and simplifying dose adjustment. Whether these pharmacological differences translate into meaningful differences in overall clinical outcomes remains uncertain. Given that anticoagulation strategies inherently require balancing thromboembolic protection against bleeding risk, evaluation using a net clinical outcome is clinically most relevant. Therefore, this randomized controlled trial is designed to determine whether edoxaban-based therapy is non-inferior to apixaban with respect to NACE, a composite of death, thromboembolic, and major bleeding outcomes in patients with AF and concomitant CAD.
- Being tested
- Edoxaban, Apixaban
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EdoxabanDrug
Also called Lixiana
Edoxaban 60mg will be administered once daily orally according to the study protocol.
ApixabanDrug
Also called Eliquis
Apixaban 5mg will be administered twice a day orally according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Edoxaban-based treatment group | Experimental | Edoxaban 60mg once daily orally, continue until follow-up is complete. Receives: Drug: Edoxaban |
| Apixaban-based treatment group | Active comparator | Apixaban 5mg twice a day orally, continue until follow-up is complete. Receives: Drug: Apixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (1)
Major Adverse Cardiovascular and Cerebrovascular Events (MACEE)
a composite of death from any causes, Myocardial Infarction, or Stroke
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start20 Jul 2026
- Primary completion1 Jun 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joo-Yong Hahn, Samsung Medical Center
- Investigators
- Joo-yong Hahn, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753200
- Sponsor's protocol ID
- SMC 2026-05-061
- Acronym
- SMARTDECISION3
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Net Clinical Benefit of Edoxaban Versus Apixaban in Patients With Atrial Fibrillation and Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT07753200
- Acronym / sponsor ID
- SMARTDECISION3 / SMC 2026-05-061
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- 1 Jun 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Non-vitamin K antagonist oral anticoagulants (NOACs) have become the standard of care for the prevention of thromboembolic events in patients with AF. In patients with AF and concomitant CAD, the choice of oral anticoagulant is particularly important because clinicians must balance the risks of thromboembolism, coronary ischemic events, as well as bleeding. Among available NOACs, apixaban and edoxaban share a common mechanism of factor Xa inhibition but differ substantially in dosing regimen, pharmacokinetic profile, and degree of renal elimination. In the recent COBRRA trial, apixaban was associated with significantly lower clinically relevant bleeding compared with rivaroxaban in patients with acute venous thromboembolism, without compromising efficacy against recurrent thromboembolism. Although these data support apixaban as an important benchmark NOAC, direct randomized comparisons between edoxaban and apixaban are lacking, particularly in patients with AF and coexisting CAD. Once-daily dosing and lower renal elimination fraction of edoxaban may offer practical advantages, particularly in elderly patients or those with impaired renal function, by potentially improving adherence and simplifying dose adjustment. Whether these pharmacological differences translate into meaningful differences in overall clinical outcomes remains uncertain. Given that anticoagulation strategies inherently require balancing thromboembolic protection against bleeding risk, evaluation using a net clinical outcome is clinically most relevant. Therefore, this randomized controlled trial is designed to determine whether edoxaban-based therapy is non-inferior to apixaban with respect to NACE, a composite of death, thromboembolic, and major bleeding outcomes in patients with AF and concomitant CAD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Edoxaban-based treatment group | Experimental | Drug: EdoxabanEdoxaban 60mg once daily orally, continue until follow-up is complete. |
| Apixaban-based treatment group | Active comparator | Drug: ApixabanApixaban 5mg twice a day orally, continue until follow-up is complete. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EdoxabanAlso: LixianaEdoxaban 60mg will be administered once daily orally according to the study protocol. | Drug | Edoxaban-based treatment group |
| ApixabanAlso: EliquisApixaban 5mg will be administered twice a day orally according to the study protocol. | Drug | Apixaban-based treatment group |
Primary outcome
Net Adverse Clinical Events (NACE)
Time frame: 5 years
A composite of death from any causes, Myocardial Infarction, Stroke, systemic embolic events or International Society on Thrombosis and Hemostasis major bleeding
1 secondary outcome
Major Adverse Cardiovascular and Cerebrovascular Events (MACEE)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
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ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joo-yong Hahn, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Edoxaban and Apixaban in people with Atrial Fibrillation (AF) and Coronary Arterial Disease (CAD), run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joo-Yong Hahn, MD, PhD (82-2-3410-6653, Jooyong.hahn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net Adverse Clinical Events (NACE) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.