Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-02-25 @ 4:14 AM
Study NCT ID:
NCT04121767
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2019-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Edoxaban in Thoracoscopic Ablation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}], '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': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552171', 'term': 'edoxaban'}, {'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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-31', 'studyFirstSubmitDate': '2019-10-08', 'studyFirstSubmitQcDate': '2019-10-08', 'lastUpdatePostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative stroke', 'timeFrame': '6 months', 'description': 'Number of patients showing thromboembolic neurologic complication after thoracoscopic ablation'}], 'secondaryOutcomes': [{'measure': 'Postoperative bleeding', 'timeFrame': '6 months', 'description': 'Number of patients showing bleeding events due to anticoagulation after thoracoscopic ablation'}, {'measure': 'Postoperative pericarditis', 'timeFrame': '6 months', 'description': 'Number of patients showing pericarditis requiring readmission after thoracoscopic ablation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'thoracoscopic ablation', 'anticoagulation'], 'conditions': ['Atrial Fibrillation', 'Anticoagulants and Bleeding Disorders']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the safety and efficacy of edoxaban and warfarin for prevention of stroke during a 6-month follow up after total thoracoscopic ablation.', 'detailedDescription': 'In Korea, 5% of patients older than 65 years and 10% of patients older than 80 have a history of atrial fibrillation (AF), which is often associated with sudden death and stroke. Medication and percutaneous radiofrequency catheter ablation are commonly used treatment modalities. Pharmacotherapy is primarily symptomatic treatment; moreover, the effect of conversion to a normal rhythm is minimal, and mainly aimed at stabilizing heart rate. Catheter ablation is associated with a high incidence of recurrence in chronic AF, and it is difficult to treat left atrial appendage, thereby preventing discontinuation of anticoagulation therapy post procedure. Thoracoscopic ablation is known to be a less invasive and more effective modality to treat patients with chronic atrial fibrillation. However, anticoagulation therapy is mandatory in the early postoperative period due to intracardiac thromboembolism associated with atrial stunning despite conversion to a sinus rhythm and resection of the left atrial appendage. Further investigation would be required to assess the efficacy and safety of novel oral anticoagulants such as edoxaban compared to that of warfarin for stroke prevention during the early postoperative period (6 months) after a thoracoscopic procedure. The need to maintain a constant level of blood coagulation and the potential development of complications such as hemorrhages are drawbacks associated with the use of warfarin. While novel oral anticoagulants such as edoxaban do have a role in atrial fibrillation, data regarding their effectiveness and incidence of complications after arrhythmia surgery do not exist. In this study, we will compare warfarin and edoxaban with respect to safety and efficacy, after they are used for 6 months following thoracoscopic ablation in patients with chronic atrial fibrillation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged 18 years or older (not exceed 80 years old).\n2. Elective thoracoscopic ablation.\n3. Presence of atrial fibrillation (paroxysmal, persistent, long-standing persistent).\n\nExclusion Criteria:\n\n1. Chronic obstructive pulmonary disease (COPD).\n2. History of pulmonary tuberculosis.\n3. Other cardiac comorbidities including valvular disease, coronary artery disease.\n4. Congenital heart anomalies except for atrial septal defect.\n5. Known, clinically important anemia or thrombocytopenia.\n6. Pregnancy or lactation.\n7. Malignancy.\n8. Intracardiac mass or thrombus\n9. Life expectancy less than 1 year.'}, 'identificationModule': {'nctId': 'NCT04121767', 'briefTitle': 'Safety and Efficacy of Edoxaban in Thoracoscopic Ablation', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Safety and Efficacy of Edoxaban Versus Warfarin in Patients Undergoing a Thoracoscopic Ablation for Persistent Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'samsungmc_TTA_edoxaban'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Edoxaban group', 'description': 'patients prescribed edoxaban after thoracoscopic ablation during window period to prevent stroke', 'interventionNames': ['Drug: Edoxaban']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Warfarin group', 'description': 'patients prescribed warfarin after thoracoscopic ablation during window period to prevent stroke', 'interventionNames': ['Drug: Warfarin']}], 'interventions': [{'name': 'Edoxaban', 'type': 'DRUG', 'otherNames': ['Savaysa'], 'description': 'oral edoxaban 60mg once daily for 3 months', 'armGroupLabels': ['Edoxaban group']}, {'name': 'Warfarin', 'type': 'DRUG', 'otherNames': ['Coumadin'], 'description': 'oral warfarin once daily for 3 months according to prothrombin time', 'armGroupLabels': ['Warfarin group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Dong Seop Jeong, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dong Seop Jeong', 'investigatorAffiliation': 'Samsung Medical Center'}}}}