- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03718559
Edoxaban Versus Edoxaban With antiPlatelet Agent In Patients With Atrial Fibrillation and Chronic Stable Coronary Artery Disease (EPIC-CAD)
March 20, 2024 updated by: Gi-Byoung Nam
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).
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1040
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Anyang, Korea, Republic of
- Hallym University Medical Center
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Bucheon, Korea, Republic of
- Soon Chun Hyang University Hospital Bucheon
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Daegu, Korea, Republic of
- Keimyung University Dongsan Medical Center
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Ilsan, Korea, Republic of
- Dongguk University Ilsan Hospital
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Pusan, Korea, Republic of
- Dong-A University Hospital
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Pusan, Korea, Republic of
- Inje University Haeundae Paik Hospital
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Seongnam, Korea, Republic of
- Seoul National University Bundang Hospital
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Seoul, Korea, Republic of
- Seoul National University Hospital
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Seoul, Korea, Republic of
- Asan Medical Center
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Seoul, Korea, Republic of
- Konkuk University Medical Center
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Seoul, Korea, Republic of
- Samsung Medical Center
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Seoul, Korea, Republic of
- Kangdong KyungHee University hospital
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Seoul, Korea, Republic of
- The Catholic Univ. of Korea, Seoul St. Mary'S Hospital
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Seoul, Korea, Republic of
- The Catholic Univ.of Korea Eunpyeong St.Mary's Hospital
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Seoul, Korea, Republic of
- VHS Medical Center
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Suwon, Korea, Republic of
- The Catholic University of Korea, St. Vincent's Hospital
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Ulsan, Korea, Republic of
- Ulsan Univeristy Hospital
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Yangsan, Korea, Republic of
- Pusan National University Yangsan Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria
- A subject was ≥ 19 years of age
- Patients with nonvalvular atrial fibrillation with high embolic risk (CHA2DS2-VASc score ≥2)
Patients with Stable coronary artery disease
- In cases where clinically significant moderate or more stenosis is present, but the percentage of stenosis is not specified on result of Coronary Angiogram (CAG) or Coronary computed tomography angiography (CCTA), the determination will be at the investigator's discretion.
- 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.
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 or haemorrhage on Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) imaging test
- 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. Arteriovenous malformation vii. Vascular aneurysms viii. Spinal cord vascular abnormalities or intracerebral vascular abnormalities ix. Active bleeding x. Hemoglobin level <7.0 g/dL or platelet count ≤ 50,000 / mm3 xi. 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Edoxaban alone
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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.
Other Names:
|
Active Comparator: Combination of edoxaban plus single antiplatelet
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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.
Other Names:
Type of antiplatelet agent is dependant upon the investigator's discretion, but aspirin 100mg once daily or clopidogrel 75mg once daily was recommended.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of net Clinical Outcome
Time Frame: 1 year
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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
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of all cause death
Time Frame: 1 year
|
1 year
|
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Rate of cardiovascular death
Time Frame: 1 year
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1 year
|
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Rate of myocardial infarction
Time Frame: 1 year
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1 year
|
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Rate of ischemic stroke
Time Frame: 1 year
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1 year
|
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Rate of systemic embolism
Time Frame: 1 year
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1 year
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Rate of unplanned revascularization
Time Frame: 1 year
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1 year
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Rate of composite of hard outcomes
Time Frame: 1 year
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all cause death, myocardial infarction, ischemic stroke, and systemic embolism
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1 year
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Rate of stent thrombosis
Time Frame: 1 year
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1 year
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Rate of fatal bleeding
Time Frame: 1 year
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International Society on Thrombosis and Haemostasis(ISTH), The Bleeding Academic Research Consortium (BARC)5
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1 year
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Rate of major bleeding
Time Frame: 1 year
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ISTH, BARC 3, The Thrombolysis in Myocardial Infarction (TIMI) major bleeding
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1 year
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Rate of minor bleeding
Time Frame: 1 year
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ISTH, BARC and TIMI criteria
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1 year
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Rate of intracranial hemorrhage
Time Frame: 1 year
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1 year
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Rate of gastrointestinal hemorrhage
Time Frame: 1 year
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1 year
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Rate of composite of Major or clinically relevant non-major bleeding
Time Frame: 1 year
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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.
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Duk-woo Park, MD, Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 14, 2019
Primary Completion (Actual)
November 8, 2023
Study Completion (Actual)
November 8, 2023
Study Registration Dates
First Submitted
October 23, 2018
First Submitted That Met QC Criteria
October 23, 2018
First Posted (Actual)
October 24, 2018
Study Record Updates
Last Update Posted (Actual)
March 22, 2024
Last Update Submitted That Met QC Criteria
March 20, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Pain
- Neurologic Manifestations
- Arrhythmias, Cardiac
- Chest Pain
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Atrial Fibrillation
- Angina Pectoris
- Angina, Stable
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protease Inhibitors
- Factor Xa Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Anticoagulants
- Edoxaban
- Platelet Aggregation Inhibitors
Other Study ID Numbers
- AMCCVEP2018-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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