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Atrial FibrillationPhase 4EPIC-CADNCT03718559

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

A Phase 4 study testing Edoxaban Monotherapy and Edoxaban plus Single Antiplatelet Agent in people with Atrial Fibrillation and Coronary Artery Disease, run by Gi-Byoung Nam at 18 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Edoxaban Monotherapy and Edoxaban plus Single Antiplatelet Agent
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,040 participants
Where
18 sitesSouth Korea
Study dates
14 May 2019to 8 Nov 2023
Phase
Phase 4
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A subject was ≥ 18 years of age
  • Patients with nonvalvular atrial fibrillation with high embolic risk (CHA2DS2-VASc score ≥2)
  • Patients with Stable coronary artery disease
  • Anatomically confirmed coronary artery disease (with ≥50% stenosis of major epicardial coronary artery documented by cardiac catheterization or coronary computed tomographic angiography) on medical therapy alone.
  • Revascularized coronary artery disease (either Percutaneous Coronary Intervention or coronary bypass surgery) whom the last revascularization should be performed ≥12 months before study enrollment for the acute coronary syndrome and ≥6 months for stable angina pectoris.

Who cannot join

  • Patients with thrombocytopenia
  • High risk of bleeding which prohibits the anticoagulant use. (baseline comorbidities, hyper or hypercoagulable state, increased prothrombin time or activated partial thromboplastin time)
  • Prior history of intracranial haemorrhage
  • Mechanical prosthetic valve or moderate to severe mitral stenosis
  • The risk of bleeding increased due to the following reasons;
  • i. history of gastrointestinal ulcers within 1 month
Show all 25Show fewer
  • ii. Malignant tumor with high risk of bleeding
  • iii. Brain or spinal cord injury within 1 month
  • iv. History of intracranial or intracerebral hemorrhage within 12 months
  • v. Esophageal varices
  • vi. Spinal cord vascular abnormalities or intracerebral vascular abnormalities
  • vii. Active bleeding
  • viii. Hemoglobin level <7.0 g/dL or platelet count ≤ 50,000 / mm3
  • ix. History of major surgery within 1 month
  • Uncontrolled severe hypertension
  • Hemodynamically Unstable or pulmonary embolism requiring thrombolysis or pulmonary embolectomy
  • History of hypersensitivity to Edoxaban, aspirin, or clopidogrel
  • Genetic problem with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  • Planned Percutaneous Coronary Intervention or coronary bypass surgery was planned within 1 year after randomization
  • Liver cirrhosis or liver dysfunction (AST or ALT > x3 of normal range or coagulation abnormality)
  • Estimated CrCl by Cockcroft-Gault equation<15 mL/min
  • Life expectancy less than 12 months
  • The subject was unable to provide written informed consent or participate in long-term follow-up
  • Pregnant and/or lactating women
  • Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

South Korea18 sites

  • Hallym University Medical Center

    Anyang

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon-si

  • Keimyung University Dongsan Medical Center

    Daegu

  • Dongguk University Ilsan Hospital

    Ilsan

  • Dong-A University Hospital

    Pusan

  • Inje University Haeundae Paik Hospital

    Pusan

  • Seoul National University Bundang Hospital

    Seongnam

  • Asan Medical Center

    Seoul

  • Kangdong KyungHee University hospital

    Seoul

  • Konkuk University Medical Center

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • The Catholic Univ. of Korea, Seoul St. Mary's Hospital

    Seoul

  • The Catholic Univ.of Korea Eunpyeong St.Mary's Hospital

    Seoul

  • VHS medical center

    Seoul

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon

  • Ulsan Univeristy Hospital

    Ulsan

  • Pusan National University Yangsan Hospital

    Yangsan

Other trials in South Korea

About this study

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

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).

Being tested
Edoxaban Monotherapy, Edoxaban plus Single Antiplatelet Agent
Keywords
Edoxaban, antiplatelet, anticoagulant
Medical subject headings
Atrial Fibrillation, Coronary Artery Disease, Angina, Stable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Edoxaban MonotherapyDrug

    Also called Lixiana™

    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.

Study groups in NCT03718559
Study groupRoleWhat they receive
Edoxaban aloneExperimentalNot described
Receives: Drug: Edoxaban Monotherapy
Combination of edoxaban plus single antiplateletActive comparatorNot described
Receives: Drug: Edoxaban plus Single Antiplatelet Agent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of net Clinical Outcome

    composites of death, stroke, systemic embolic event, myocardial infarction, unplanned revascularization of a major coronary artery, major bleeding, and clinically relevant non-major bleeding event

    Measured: 1 year

Secondary outcomes (14)

  1. Rate of all cause death

    Measured: 1 year

  2. Rate of cardiovascular death

    Measured: 1 year

  3. Rate of myocardial infarction

    Measured: 1 year

  4. Rate of ischemic stroke

    Measured: 1 year

  5. Rate of systemic embolism

    Measured: 1 year

  6. Rate of unplanned revascularization

    Measured: 1 year

  7. Rate of composite of hard outcomes

    all cause death, myocardial infarction, ischemic stroke, and systemic embolism

    Measured: 1 year

  8. Rate of stent thrombosis

    Measured: 1 year

  9. Rate of composite of Major or clinically relevant non-major bleeding

    1. Major bleeding
    • Fatal bleeding
    • Bleeding in the critical site (Intracranial, retroperitoneal, intraocular, intraspinal, intra-articular, pericardial, intramuscular with compartment syndrome)
    • Bleeding causing a fall in haemoglobin level of 2g/dL or leading to transfusion of two or more units of whole blood or red cells.
    1. Clinically relevant non-major bleeding defined as any sign or symptom of haemorrhage that does not fit the criteria for The International Society on Thrombosis and Haemostasis (ISTH) major bleeding but requiring medical intervention, leading to hospitalization, or prompting a medical evaluation. Specifically bleeding that meet one of following criteria.
    • bleeding that resulted in hospitalization
    • medical or surgical intervention for bleeding
    • an unscheduled clinic visit, or
    • a change in physician-directed antithrombotic therapy.

    Measured: 1 year

  10. Rate of fatal bleeding

    International Society on Thrombosis and Haemostasis(ISTH), The Bleeding Academic Research Consortium (BARC)5

    Measured: 1 year

  11. Rate of major bleeding

    ISTH, BARC 3, The Thrombolysis in Myocardial Infarction (TIMI) major bleeding

    Measured: 1 year

  12. Rate of minor bleeding

    ISTH, BARC and TIMI criteria

    Measured: 1 year

  13. Rate of intracranial hemorrhage

    Measured: 1 year

  14. Rate of gastrointestinal hemorrhage

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2018
  2. Study start14 May 2019
  3. Primary completion8 Nov 2023
  4. Study completion8 Nov 2023

Resources

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
None (open label)
Enrolment
1,040 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03718559
Sponsor's protocol ID
AMCCVEP2018-01
Acronym
EPIC-CAD
Status last verified
Jun 2024
First submitted
23 Oct 2018
Last updated
10 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lee S, Cho MS, Kang DY, Ahn JM, Lee JB, Park HS, An SY, Wee SB, Seo KW, Oh YS, Lee CH, Choi EK, Lee JH, Kwon CH, Park GM, Choi HO, Park KH, Park KM, Hwang J, Yoo KD, Cho YR, Kim JH, Hwang KW, Jin ES, Kwon O, Kim KH, Park SJ, Nam GB, Park DW; EPIC-CAD Investigators. Edoxaban antithrombotic therapy in diabetic patients with atrial fibrillation and stable coronary artery disease: the EPIC-CAD trial. Europace. 2026 Oct 1;28(10):euag247. doi: 10.1093/europace/euag247.

    PubMed 42690164

  • Lee JM, Cho MS, Kang DY, Ahn JM, Oh YS, Lee CH, Choi EK, Lee JH, Kwon CH, Park GM, Choi HO, Park KH, Park KM, Hwang J, Yoo KD, Cho YR, Kim JH, Hwang KW, Jin ES, Kwon O, Kim KH, Park SJ, Nam GB, Park DW. Impact of renal function on edoxaban antithrombotic therapy in patients with atrial fibrillation and stable coronary artery disease: a prespecified analysis of the EPIC-CAD trial. EuroIntervention. 2026 Apr 20;22(8):e432-e443. doi: 10.4244/EIJ-D-25-01274.

    PubMed 42003300

  • Yu JS, Cho MS, Kang DY, Ahn JM, Lee JB, Oh YS, Lee CH, Choi EK, Lee JH, Kwon CH, Park GM, Choi HO, Park KH, Park KM, Hwang JM, Yoo KD, Cho YR, Kim JH, Hwang KW, Jin ES, Kwon O, Kim KH, Park SJ, Nam GB, Park DW; EPIC-CAD Investigators. Impact of Atrial Fibrillation Pattern on Edoxaban Antithrombotic Therapy in Patients With Atrial Fibrillation and Stable Coronary Artery Disease: A Secondary Analysis of the EPIC-CAD Randomized Clinical Trial. J Am Heart Assoc. 2026 Apr 7;15(7):e046966. doi: 10.1161/JAHA.125.046966. Epub 2026 Mar 18.

    PubMed 41848064

  • Kim GH, Cho M, Kim S, Kang DY, Ahn JM, Oh YS, Lee CH, Choi EK, Lee JH, Kwon CH, Park GM, Choi HO, Park KH, Park KM, Hwang J, Yoo KD, Cho YR, Kim JH, Hwang KW, Jin ES, Kwon O, Kim KH, Park SJ, Nam GB, Park DW; EPIC-CAD Investigators. Sex-Based Differences in Clinical Outcomes With Edoxaban Therapy: A Prespecified Analysis of the EPIC-CAD Trial. JACC Asia. 2026 May;6(5):587-598. doi: 10.1016/j.jacasi.2025.12.022. Epub 2026 Feb 28.

    PubMed 41762182

  • Cho MS, Kang DY, Lee JB, Oh YS, Lee CH, Choi EK, Lee JH, Kwon CH, Park GM, Choi HO, Park KH, Park KM, Hwang J, Yoo KD, Cho YR, Kim JH, Hwang KW, Jin ES, Kwon O, Kim KH, Park DW, Nam GB; on the behalf of the EPIC-CAD Investigators. Off-label underdosing of edoxaban antithrombotic therapy for patients with atrial fibrillation and stable coronary artery disease: findings from the EPIC-CAD trial. Heart. 2026 Mar 12;112(7):391-398. doi: 10.1136/heartjnl-2025-326646.

    PubMed 40930594

  • Cho MS, Kang DY, Ahn JM, Yun SC, Oh YS, Lee CH, Choi EK, Lee JH, Kwon CH, Park GM, Choi HO, Park KH, Park KM, Hwang J, Yoo KD, Cho YR, Kim JH, Hwang KW, Jin ES, Kwon O, Kim KH, Park SJ, Park DW, Nam GB; EPIC-CAD Investigators. Edoxaban Antithrombotic Therapy for Atrial Fibrillation and Stable Coronary Artery Disease. N Engl J Med. 2024 Dec 5;391(22):2075-2086. doi: 10.1056/NEJMoa2407362. Epub 2024 Sep 1.

    PubMed 39225258

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Edoxaban Monotherapy and Edoxaban plus Single Antiplatelet Agent in people with Atrial Fibrillation and Coronary Artery Disease, run by Gi-Byoung Nam at 18 sites 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 5 inclusion and 25 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: finished, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of net Clinical Outcome (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03718559, which also lists 6 linked publications.

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 Jun 2024.

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