Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-04-08 @ 6:45 AM
Study NCT ID:
NCT01991951
Status:
UNKNOWN
Last Update Posted:
2013-11-25
First Post:
2013-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short Term Warfarin Therapy for Radiofrequency Catheter Ablation of Atrial Fibrillation
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014859', 'term': 'Warfarin'}], 'ancestors': [{'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 520}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-11-21', 'studyFirstSubmitDate': '2013-11-18', 'studyFirstSubmitQcDate': '2013-11-21', 'lastUpdatePostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of thromboembolic and bleeding events during 2 months', 'timeFrame': '2 months after the procedure'}]}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'We hypothesized that in patients with low CHADS-VASc score (2 or \\< 2), there is no difference in thromboembolic or bleeding events between patients with short term warfarin therapy (2 weeks after catheter ablation) and conventional therapy (3 weeks before and 8 weeks after procedure).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with paroxysmal atrial fibrillation who underwent radiofrequency catheter ablation\n* Patients with CHADS-VASc score 2 or less than 2\n\nExclusion Criteria:\n\n* Patients who do not consent to the study\n* Permanent or persistent atrial fibrillation\n* Patients who have underwent prior catheter ablation for atrial fibrillation\n* CHADS-VASc score more than 2\n* History of stroke\n* LVEF \\<40%\n* Significant liver or kidney dysfunction\n* History of major bleeding during warfarin therapy'}, 'identificationModule': {'nctId': 'NCT01991951', 'briefTitle': 'Short Term Warfarin Therapy for Radiofrequency Catheter Ablation of Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Korea University Anam Hospital'}, 'officialTitle': 'Prospective Randomized Study of Incidence of Thromboembolic and Bleeding Events According to the Period of Warfarin Use Before and After Catheter Ablation of Paroxysmal Atrial Fibrillation in Low Risk Patients', 'orgStudyIdInfo': {'id': 'KUMCEP01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Short term warfarin group', 'description': 'taking warfarin for only 2 weeks after catheter ablation of atrial fibrillation', 'interventionNames': ['Drug: warfarin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional therapy arm', 'description': 'conventional warfarin therapy of 3 weeks before and 8 weeks after catheter ablation of AF', 'interventionNames': ['Drug: warfarin']}], 'interventions': [{'name': 'warfarin', 'type': 'DRUG', 'armGroupLabels': ['Conventional therapy arm', 'Short term warfarin group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '136-705', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jaemin Shim, MD', 'role': 'CONTACT', 'email': 'jshim@kumc.or.kr', 'phone': '82-10-6776-1195'}], 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jaemin Shim, MD', 'role': 'CONTACT', 'email': 'jshim@kumc.or.kr', 'phone': '82-10-6776-1195'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University Anam Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of medicine', 'investigatorFullName': 'Young-Hoon Kim', 'investigatorAffiliation': 'Korea University Anam Hospital'}}}}