Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2026-01-01 @ 9:58 AM
Study NCT ID:
NCT02786095
Status:
UNKNOWN
Last Update Posted:
2018-06-20
First Post:
2016-05-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Study of Drugs for Symptom Control and Complication Prevention of Atrial Fibrillation (AF) (Code-AF Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-19', 'studyFirstSubmitDate': '2016-05-25', 'studyFirstSubmitQcDate': '2016-05-27', 'lastUpdatePostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all cause mortality', 'timeFrame': '3 years'}, {'measure': 'number of hospitalization by heart failure', 'timeFrame': '3 years'}, {'measure': 'number of recurrent stroke', 'timeFrame': '3 years'}, {'measure': 'number of cardiovascular events', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atrial fibrillation', 'anti arrhythmic drug', 'NOAC', 'warfarin', 'coumadin'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '36579375', 'type': 'DERIVED', 'citation': 'Park H, Yu HT, Kim TH, Park J, Park JK, Kang KW, Shim J, Kim JB, Kim J, Choi EK, Park HW, Lee YS, Joung B. Oral Anticoagulation Therapy in Atrial Fibrillation Patients with Advanced Chronic Kidney Disease: CODE-AF Registry. Yonsei Med J. 2023 Jan;64(1):18-24. doi: 10.3349/ymj.2022.0455.'}, {'pmid': '36073646', 'type': 'DERIVED', 'citation': 'Kim JY, Park HS, Park HW, Choi EK, Park JK, Kim JB, Kang KW, Shim J, Joung B, Park KM. Clinical Outcomes of Rhythm Control Strategies for Asymptomatic Atrial Fibrillation According to the Quality-of-Life Score: The CODE-AF (Comparison Study of Drugs for Symptom Control and Complication Prevention of Atrial Fibrillation) Registry. J Am Heart Assoc. 2022 Sep 20;11(18):e025956. doi: 10.1161/JAHA.122.025956. Epub 2022 Sep 8.'}, {'pmid': '35656931', 'type': 'DERIVED', 'citation': 'Kim M, Kim J, Kim JB, Park J, Park JK, Kang KW, Shim J, Choi EK, Lee YS, Park HW, Joung B. Association of Gender With Clinical Outcomes in a Contemporary Cohort of Patients With Atrial Fibrillation Receiving Oral Anticoagulants. Korean Circ J. 2022 Aug;52(8):593-603. doi: 10.4070/kcj.2021.0399. Epub 2022 Apr 26.'}, {'pmid': '35352882', 'type': 'DERIVED', 'citation': 'Lee KB, Kim TH, Park J, Park JK, Kang KW, Kim J, Park HW, Choi EK, Kim JB, Lee YS, Shim J, Joung B. Stroke and Systemic Thromboembolism according to CHA2DS2-VASc Score in Contemporary Korean Patients with Atrial Fibrillation. Yonsei Med J. 2022 Apr;63(4):317-324. doi: 10.3349/ymj.2022.63.4.317.'}]}, 'descriptionModule': {'briefSummary': 'This study is prospective Cohort study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is all patients with atrial fibrillation who visit hospital. The purpose is to analyze complication, composite outcome (all cause mortality, hospitalization, the incidence of stroke, heart failure and cardiovascular event (MACE)) according to the 1) the use of anti-arrhythmic drugs (AADs), 2) use of medication for rate control (beta blocker, calcium channel blocker and digoxin) and 3) use of anticoagulation agents (warfarin, coumadin, an NOAC)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with atrial fibrillation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with atrial fibrillation\n* patients with age more than 19\n* patients who agree with study inclusion\n\nExclusion Criteria:\n\n* patients who do not agree with study inclusion\n* patients with age less than 19\n* Pregnancy, Breastfeeding'}, 'identificationModule': {'nctId': 'NCT02786095', 'briefTitle': 'Comparison Study of Drugs for Symptom Control and Complication Prevention of Atrial Fibrillation (AF) (Code-AF Trial)', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2016-0105'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Code-AF registry'}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Boyoung Joung, MD', 'role': 'CONTACT', 'email': 'cby6908@yuhs.ac', 'phone': '82-2-2228-8460'}], 'facility': 'Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}