Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2026-02-27 @ 3:08 PM
Study NCT ID:
NCT03718559
Status:
COMPLETED
Last Update Posted:
2024-06-10
First Post:
2018-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Edoxaban Versus Edoxaban With antiPlatelet Agent In Patients With Atrial Fibrillation and Chronic Stable Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D060050', 'term': 'Angina, Stable'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552171', 'term': 'edoxaban'}, {'id': 'D010975', 'term': 'Platelet Aggregation Inhibitors'}], 'ancestors': [{'id': 'D006401', 'term': 'Hematologic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1040}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-06', 'studyFirstSubmitDate': '2018-10-23', 'studyFirstSubmitQcDate': '2018-10-23', 'lastUpdatePostDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of net Clinical Outcome', 'timeFrame': '1 year', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Rate of all cause death', 'timeFrame': '1 year'}, {'measure': 'Rate of cardiovascular death', 'timeFrame': '1 year'}, {'measure': 'Rate of myocardial infarction', 'timeFrame': '1 year'}, {'measure': 'Rate of ischemic stroke', 'timeFrame': '1 year'}, {'measure': 'Rate of systemic embolism', 'timeFrame': '1 year'}, {'measure': 'Rate of unplanned revascularization', 'timeFrame': '1 year'}, {'measure': 'Rate of composite of hard outcomes', 'timeFrame': '1 year', 'description': 'all cause death, myocardial infarction, ischemic stroke, and systemic embolism'}, {'measure': 'Rate of stent thrombosis', 'timeFrame': '1 year'}, {'measure': 'Rate of composite of Major or clinically relevant non-major bleeding', 'timeFrame': '1 year', 'description': '1. Major bleeding\n\n * Fatal bleeding\n * Bleeding in the critical site (Intracranial, retroperitoneal, intraocular, intraspinal, intra-articular, pericardial, intramuscular with compartment syndrome)\n * 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.\n2. Clinically relevant non-major bleeding\n\ndefined 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.\n\n* bleeding that resulted in hospitalization\n* medical or surgical intervention for bleeding\n* an unscheduled clinic visit, or\n* a change in physician-directed antithrombotic therapy.'}, {'measure': 'Rate of fatal bleeding', 'timeFrame': '1 year', 'description': 'International Society on Thrombosis and Haemostasis(ISTH), The Bleeding Academic Research Consortium (BARC)5'}, {'measure': 'Rate of major bleeding', 'timeFrame': '1 year', 'description': 'ISTH, BARC 3, The Thrombolysis in Myocardial Infarction (TIMI) major bleeding'}, {'measure': 'Rate of minor bleeding', 'timeFrame': '1 year', 'description': 'ISTH, BARC and TIMI criteria'}, {'measure': 'Rate of intracranial hemorrhage', 'timeFrame': '1 year'}, {'measure': 'Rate of gastrointestinal hemorrhage', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Edoxaban', 'antiplatelet', 'anticoagulant'], 'conditions': ['Atrial Fibrillation', 'Coronary Artery Disease', 'Stable Angina', 'Stable Chronic Angina']}, 'referencesModule': {'references': [{'pmid': '40930594', 'type': 'DERIVED', 'citation': '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': '39225258', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. A subject was ≥ 18 years of age\n2. Patients with nonvalvular atrial fibrillation with high embolic risk (CHA2DS2-VASc score ≥2)\n3. Patients with Stable coronary artery disease\n\n * 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.\n * 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.\n\nExclusion Criteria\n\n1. Patients with thrombocytopenia\n2. High risk of bleeding which prohibits the anticoagulant use. (baseline comorbidities, hyper or hypercoagulable state, increased prothrombin time or activated partial thromboplastin time)\n3. Prior history of intracranial haemorrhage\n4. Mechanical prosthetic valve or moderate to severe mitral stenosis\n5. The risk of bleeding increased due to the following reasons;\n\n * i. history of gastrointestinal ulcers within 1 month\n * ii. Malignant tumor with high risk of bleeding\n * iii. Brain or spinal cord injury within 1 month\n * iv. History of intracranial or intracerebral hemorrhage within 12 months\n * v. Esophageal varices\n * vi. Spinal cord vascular abnormalities or intracerebral vascular abnormalities\n * vii. Active bleeding\n * viii. Hemoglobin level \\<7.0 g/dL or platelet count ≤ 50,000 / mm3\n * ix. History of major surgery within 1 month\n6. Uncontrolled severe hypertension\n7. Hemodynamically Unstable or pulmonary embolism requiring thrombolysis or pulmonary embolectomy\n8. History of hypersensitivity to Edoxaban, aspirin, or clopidogrel\n9. Genetic problem with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption\n10. Planned Percutaneous Coronary Intervention or coronary bypass surgery was planned within 1 year after randomization\n11. Liver cirrhosis or liver dysfunction (AST or ALT \\> x3 of normal range or coagulation abnormality)\n12. Estimated CrCl by Cockcroft-Gault equation\\<15 mL/min\n13. Life expectancy less than 12 months\n14. The subject was unable to provide written informed consent or participate in long-term follow-up\n15. Pregnant and/or lactating women\n16. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period'}, 'identificationModule': {'nctId': 'NCT03718559', 'acronym': 'EPIC-CAD', 'briefTitle': 'Edoxaban Versus Edoxaban With antiPlatelet Agent In Patients With Atrial Fibrillation and Chronic Stable Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'A Multi-centre, Open-labelled, Randomized Controlled Trial Comparing Two Different Anticoagulation Strategies in High-risk Atrial Fibrillation and Stable Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'AMCCVEP2018-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Edoxaban alone', 'interventionNames': ['Drug: Edoxaban Monotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Combination of edoxaban plus single antiplatelet', 'interventionNames': ['Drug: Edoxaban plus Single Antiplatelet Agent']}], 'interventions': [{'name': 'Edoxaban Monotherapy', 'type': 'DRUG', 'otherNames': ['Lixiana™'], 'description': '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.', 'armGroupLabels': ['Edoxaban alone']}, {'name': 'Edoxaban plus Single Antiplatelet Agent', 'type': 'DRUG', 'description': "Type of antiplatelet agent is dependant upon the investigator's discretion, but aspirin 100mg once daily or clopidogrel 75mg once daily was recommended.", 'armGroupLabels': ['Combination of edoxaban plus single antiplatelet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anyang', 'country': 'South Korea', 'facility': 'Hallym University Medical Center', 'geoPoint': {'lat': 36.9577, 'lon': 127.1464}}, {'city': 'Bucheon-si', 'country': 'South Korea', 'facility': 'Soon Chun Hyang University Hospital Bucheon', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Ilsan', 'country': 'South Korea', 'facility': 'Dongguk University Ilsan Hospital', 'geoPoint': {'lat': 35.5, 'lon': 129.43333}}, {'city': 'Pusan', 'country': 'South Korea', 'facility': 'Dong-A University Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Pusan', 'country': 'South Korea', 'facility': 'Inje University Haeundae Paik Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Seongnam', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kangdong KyungHee University hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Konkuk University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic Univ. of Korea, Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic Univ.of Korea Eunpyeong St.Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'VHS medical center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Suwon', 'country': 'South Korea', 'facility': "The Catholic University of Korea, St. Vincent's Hospital", 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'city': 'Ulsan', 'country': 'South Korea', 'facility': 'Ulsan Univeristy Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}, {'city': 'Yangsan', 'country': 'South Korea', 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}], 'overallOfficials': [{'name': 'Duk-woo Park, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gi-Byoung Nam', 'class': 'OTHER'}, 'collaborators': [{'name': 'CardioVascular Research Foundation, Korea', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea', 'investigatorFullName': 'Gi-Byoung Nam', 'investigatorAffiliation': 'Asan Medical Center'}}}}