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| Name | Class |
|---|---|
| CardioVascular Research Foundation, Korea | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Edoxaban alone | Experimental |
| |
| Combination of edoxaban plus single antiplatelet | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edoxaban Monotherapy | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of all cause death | 1 year | |
| Rate of cardiovascular death | 1 year | |
| Rate of myocardial infarction |
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Inclusion Criteria
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
Exclusion Criteria
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;
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
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| Name | Affiliation | Role |
|---|---|---|
| Duk-woo Park, MD | Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Medical Center | Anyang | South Korea | ||||
| Soon Chun Hyang University Hospital Bucheon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42003300 | Derived | 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. | |
| 41848064 |
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|
| Edoxaban plus Single Antiplatelet Agent | Drug | Type of antiplatelet agent is dependant upon the investigator's discretion, but aspirin 100mg once daily or clopidogrel 75mg once daily was recommended. |
|
| 1 year |
| Rate of ischemic stroke | 1 year |
| Rate of systemic embolism | 1 year |
| Rate of unplanned revascularization | 1 year |
| Rate of composite of hard outcomes | all cause death, myocardial infarction, ischemic stroke, and systemic embolism | 1 year |
| Rate of stent thrombosis | 1 year |
| Rate of composite of Major or 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.
| 1 year |
| Rate of fatal bleeding | International Society on Thrombosis and Haemostasis(ISTH), The Bleeding Academic Research Consortium (BARC)5 | 1 year |
| Rate of major bleeding | ISTH, BARC 3, The Thrombolysis in Myocardial Infarction (TIMI) major bleeding | 1 year |
| Rate of minor bleeding | ISTH, BARC and TIMI criteria | 1 year |
| Rate of intracranial hemorrhage | 1 year |
| Rate of gastrointestinal hemorrhage | 1 year |
| Bucheon-si |
| South Korea |
| Keimyung University Dongsan Medical Center | Daegu | South Korea |
| Dongguk University Ilsan Hospital | Ilsan | South Korea |
| Dong-A University Hospital | Pusan | South Korea |
| Inje University Haeundae Paik Hospital | Pusan | South Korea |
| Seoul National University Bundang Hospital | Seongnam | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Kangdong KyungHee University hospital | Seoul | South Korea |
| Konkuk University Medical Center | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| The Catholic Univ. of Korea, Seoul St. Mary's Hospital | Seoul | South Korea |
| The Catholic Univ.of Korea Eunpyeong St.Mary's Hospital | Seoul | South Korea |
| VHS medical center | Seoul | South Korea |
| The Catholic University of Korea, St. Vincent's Hospital | Suwon | South Korea |
| Ulsan Univeristy Hospital | Ulsan | South Korea |
| Pusan National University Yangsan Hospital | Yangsan | South Korea |
| Derived |
| 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. |
| 41762182 | Derived | 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. |
| 40930594 | Derived | 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. |
| 39225258 | Derived | 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. |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D003324 | Coronary Artery Disease |
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C552171 | edoxaban |
| D010975 | Platelet Aggregation Inhibitors |
| ID | Term |
|---|---|
| D006401 | Hematologic Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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