Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2025-12-25 @ 9:42 PM
Study NCT ID:
NCT01607359
Status:
WITHDRAWN
Last Update Posted:
2023-05-11
First Post:
2012-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dabigatran Versus Warfarin Anticoagulation Before and After Catheter Ablation for the Treatment 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Withdrawn: It was decided not to proceed with the study at this time.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-10', 'studyFirstSubmitDate': '2012-05-24', 'studyFirstSubmitQcDate': '2012-05-24', 'lastUpdatePostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical stroke, TIA or systemic embolic complication', 'timeFrame': '30 days before or after catheter ablation', 'description': 'Thromboembolic complication recorded in clinical records.'}, {'measure': 'Bleeding complication', 'timeFrame': '30 days before or after catheter ablation', 'description': 'Any bleeding causing additional intervention, hospitalization or pain and suffering including pericardial tamponade, large hematoma or other bleeding.'}], 'secondaryOutcomes': [{'measure': 'Any significant complication', 'timeFrame': '30 days before or after catheter ablation', 'description': 'Any significant complication that is related to the catheter ablation procedure or to the anticoagulation regimen'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'catheter ablation', 'dabigatran', 'warfarin', 'oral anticoagulation'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Both warfarin and dabigatran have been used for stroke prophylaxis at the time of catheter ablation of atrial fibrillation. Although the risks of thromboembolism and bleeding with warfarin are well established, the relative risk and benefit of dabigatran in this setting are unknown. The purposes of the study are to assess the efficacy of warfarin versus dabigatran in the prevention of stroke and other systemic embolic complications before and after catheter ablation for AF, and to compare the prevalence of serious bleeding complications with the two OAC agents.', 'detailedDescription': "* Data from patients collected from 4 US and 1 Canadian medical center\n* Retrospective record review of all patients that had undergone catheter ablation of atrial fibrillation during the time period beginning with the initiation of dabigatran therapy for stroke prophylaxis at each center and ending in November 2011.\n* Dabigatran study group comprised of all patients that received dabigatran for stroke prophylaxis during the study time period.\n* Warfarin comparison group to be selected from all patients that received warfarin for stroke prophylaxis during the identical study time period.\n* Warfarin patients will be numbered sequentially\n* A subgroup of warfarin patients identical in number to the dabigatran patients at each center will be selected using random number generator.\n\nPatient data sets will be de-identified and compiled\n\n* Master data set to be stored in Excel file\n* Statistics to be performed with SAS (Cary, NC)\n* Continuous data to be expressed as means ± S.D., compared with unpaired t-tests\n* Categorical data will be compared with Fisher's exact test or Chi-square\n* Complications including any thromboembolic events or any bleeding events will be recorded and the prevalence compared."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients undergoing catheter ablation for atrial fibrillation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing catheter ablation for atrial fibrillation\n\nExclusion Criteria:\n\n* none (retrospective trial)'}, 'identificationModule': {'nctId': 'NCT01607359', 'briefTitle': 'Dabigatran Versus Warfarin Anticoagulation Before and After Catheter Ablation for the Treatment of Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Corewell Health East'}, 'officialTitle': 'Dabigatran Versus Warfarin Anticoagulation Before and After Catheter Ablation for the Treatment of Atrial Fibrillation', 'orgStudyIdInfo': {'id': '2007088'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'dabigatran group', 'description': 'All patients receiving dabigatran as periprocedural anticoagulation during the study time period'}, {'label': 'warfarin group', 'description': 'A randomly selected group of patients treated with warfarin during the study time period matching the number of dabigatran treated patients in the same time period.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'Beaumont Health System', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corewell Health East', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Pennsylvania', 'class': 'OTHER'}, {'name': 'Johns Hopkins University', 'class': 'OTHER'}, {'name': 'London Health Sciences Centre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}