Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT06874894
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-03-13
First Post:
2025-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thromboembolic And Bleeding Risks During anticoaGulant trEatment in Asian paTients With Atrial Fibrillation (TARGET-AF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006470', 'term': 'Hemorrhage'}], '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': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1100}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-08', 'studyFirstSubmitDate': '2025-03-08', 'studyFirstSubmitQcDate': '2025-03-08', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'COVID-19 infection', 'timeFrame': '12 months', 'description': 'Confirmation of COVID-19 infection and primary outcome'}], 'primaryOutcomes': [{'measure': 'Clinical ischemic and hemorrhagic events', 'timeFrame': '12 months', 'description': 'Ischemic stroke, systemic embolism, or myocardial infarction andISTH major/minor bleeding events'}], 'secondaryOutcomes': [{'measure': 'Clinical other events', 'timeFrame': '12 months', 'description': 'Major Adverse Cardiovascular Events: Myocardial infarction, ischemic stroke, systemic embolism, and cardiovascular death (including bleeding).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Stroke', 'Bleeding'], 'conditions': ['Fibrillation, Atrial']}, 'referencesModule': {'references': [{'pmid': '36857519', 'type': 'RESULT', 'citation': 'Lee SH, Kim HK, Ahn JH, Kang MG, Kim KH, Bae JS, Cho SY, Koh JS, Park Y, Hwang SJ, Gorog DA, Tantry US, Bliden KP, Gurbel PA, Hwang JY, Jeong YH. Prognostic impact of hypercoagulability and impaired fibrinolysis in acute myocardial infarction. Eur Heart J. 2023 May 14;44(19):1718-1728. doi: 10.1093/eurheartj/ehad088.'}]}, 'descriptionModule': {'briefSummary': 'This study was design to investigate the efficacy and safety of NOAC therapy in Koreans', 'detailedDescription': 'East Asians have demonstrated a higher bleeding tendency compared to Western populations during an anticoagulation. Consequently, East Asians have been prescribed as a relatively weaker treatment regimens based on this evidence. Therefore, the TARGET-AF study aims to verify the efficacy and safety of NOAC therapy in Koreans'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'AF patients with NOAC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with documented AF on 12-lead ECG, Holter monitoring, or single-lead ECG recordings are eligible for enrollment.\n* Based on AF treatment Korean guideline 19, AF patients who require NOAC treatment or are currently on NOAC treatment (within the past 3 months)\n* Adults aged 18 or above who have provided consent for clinical information\n\nExclusion Criteria:\n\n* Patients with moderate or severe mitral stenosis or mechanical prosthetic valve'}, 'identificationModule': {'nctId': 'NCT06874894', 'acronym': 'NOAC', 'briefTitle': 'Thromboembolic And Bleeding Risks During anticoaGulant trEatment in Asian paTients With Atrial Fibrillation (TARGET-AF)', 'organization': {'class': 'OTHER', 'fullName': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine'}, 'officialTitle': 'Thromboembolic and Bleeding Risk During Anticoagulant Treatment in Asian Patents With Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'CAUH 1992-002-387'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Atrial Fibrillation', 'description': 'Documented AF on 12-lead ECG, Holter monitoring, or single-lead ECG recordings with NOAC treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06973', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Chung-Ang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chung-Ang University Gwangmyeong Hospital', 'class': 'OTHER'}, {'name': 'Samsung Medical Center', 'class': 'OTHER'}, {'name': 'Korea University Ansan Hospital', 'class': 'OTHER'}, {'name': 'Kosin University Gospel Hospital', 'class': 'OTHER'}, {'name': 'Keimyung University Dongsan Medical Center', 'class': 'OTHER'}, {'name': 'Yuhan Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ki-Woon Kang', 'investigatorAffiliation': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine'}}}}