Edoxaban Versus Edoxaban With antiPlatelet Agent In Patients With Atrial Fibrillation and Chronic Stable Coronary Artery Disease
EPIC-CAD
A Multi-centre, Open-labelled, Randomized Controlled Trial Comparing Two Different Anticoagulation Strategies in High-risk Atrial Fibrillation and Stable Coronary Artery Disease
1 other identifier
interventional
1,040
1 country
18
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 atrial-fibrillation
Started May 2019
Typical duration for phase_4 atrial-fibrillation
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2018
CompletedFirst Posted
Study publicly available on registry
October 24, 2018
CompletedStudy Start
First participant enrolled
May 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 8, 2023
CompletedJune 10, 2024
June 1, 2024
4.5 years
October 23, 2018
June 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
1 year
Secondary Outcomes (14)
Rate of all cause death
1 year
Rate of cardiovascular death
1 year
Rate of myocardial infarction
1 year
Rate of ischemic stroke
1 year
Rate of systemic embolism
1 year
- +9 more secondary outcomes
Study Arms (2)
Edoxaban alone
EXPERIMENTALCombination of edoxaban plus single antiplatelet
ACTIVE COMPARATORInterventions
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.
Type of antiplatelet agent is dependant upon the investigator's discretion, but aspirin 100mg once daily or clopidogrel 75mg once daily was recommended.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gi-Byoung Namlead
- CardioVascular Research Foundation, Koreacollaborator
Study Sites (18)
Hallym University Medical Center
Anyang, South Korea
Soon Chun Hyang University Hospital Bucheon
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
Related Publications (2)
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. 2025 Sep 9:heartjnl-2025-326646. doi: 10.1136/heartjnl-2025-326646. Online ahead of print.
PMID: 40930594DERIVEDCho 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.
PMID: 39225258DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Duk-woo Park, MD
Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
Study Record Dates
First Submitted
October 23, 2018
First Posted
October 24, 2018
Study Start
May 14, 2019
Primary Completion
November 8, 2023
Study Completion
November 8, 2023
Last Updated
June 10, 2024
Record last verified: 2024-06