Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-28 @ 12:00 AM
Study NCT ID:
NCT05279833
Status:
COMPLETED
Last Update Posted:
2024-01-09
First Post:
2022-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Systematic Review and Meta-Analysis of Multaq® for Safety in 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': 'D000077764', 'term': 'Dronedarone'}, {'id': 'D013015', 'term': 'Sotalol'}], 'ancestors': [{'id': 'D000638', 'term': 'Amiodarone'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87810}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-05', 'studyFirstSubmitDate': '2022-02-17', 'studyFirstSubmitQcDate': '2022-03-14', 'lastUpdatePostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Cardiovascular (CV) hospitalization', 'timeFrame': 'As reported in studies included in the systematic review up to 10 years', 'description': 'CV hospitalization is defined as composite of heart failure hospitalization, AFib hospitalization, MI, and stroke'}, {'measure': 'Number of participants with ventricular proarrhythmia', 'timeFrame': 'As reported in studies included in the systematic review up to 10 years'}, {'measure': 'Number of all-cause mortality events', 'timeFrame': 'As reported in studies included in the systematic review up to 10 years'}, {'measure': 'Number of cardiovascular mortality events', 'timeFrame': 'As reported in studies included in the systematic review up to 10 years', 'description': 'includes arrhythmia-related mortality'}, {'measure': 'Number of participants with atrial fibrillation (AFib) recurrence', 'timeFrame': 'As reported in studies included in the systematic review up to 10 years'}], 'secondaryOutcomes': [{'measure': 'Number of participants with myocardial infarction', 'timeFrame': 'As reported in studies included in the systematic review up to 10 years'}, {'measure': 'Number of participants with stroke', 'timeFrame': 'As reported in studies included in the systematic review up to 10 years'}, {'measure': 'Number of participants with heart failure hospitalization', 'timeFrame': 'As reported in studies included in the systematic review up to 10 years'}, {'measure': 'Number of participants with AFib hospitalization', 'timeFrame': 'As reported in studies included in the systematic review up to 10 years'}, {'measure': 'Number of participants with conduction disorders', 'timeFrame': 'As reported in studies included in the systematic review up to 10 years', 'description': 'Atrioventricular block (2nd or 3rd degree) or Requirement of pacemaker implants'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '37025083', 'type': 'RESULT', 'citation': 'Singh JP, Blomstrom-Lundqvist C, Turakhia MP, Camm AJ, Fazeli MS, Kreidieh B, Crotty C, Kowey PR. Dronedarone versus sotalol in patients with atrial fibrillation: A systematic literature review and network meta-analysis. Clin Cardiol. 2023 Jun;46(6):589-597. doi: 10.1002/clc.24011. Epub 2023 Apr 6.'}]}, 'descriptionModule': {'briefSummary': 'A systematic literature review (SLR) will be conducted to understand the landscape of evidence on the relative safety and effectiveness/efficacy of dronedarone compared to sotalol in patients with AFib within interventional clinical trials and observational studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with AFib (non-permanent, including paroxysmal or persistent, long-standing persistent AFib \\[over 12 months\\])', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFollowing eligibility criteria are defined to select relevant studies from the literature\n\n* Adults with Atrial Fibrillation(AFib) (non-permanent, including paroxysmal or persistent, long-standing persistent AFib \\[over 12 months\\]))\n* Participants have received either Dronedarone or Sotalol\n* controlled clinical trials or comparative observational studies( prospective/retrospective cohort, case-control studies, population-based studies or registry based studies\n\nExclusion Criteria:\n\nExclusion criteria for potential participants are:\n\n* Children/adolescents\n* Permanent atrial fibrillation (AFib)'}, 'identificationModule': {'nctId': 'NCT05279833', 'briefTitle': 'Systematic Review and Meta-Analysis of Multaq® for Safety in Atrial Fibrillation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'SLR/NMA of Multaq® vs Sotalol to Assess for Safety in Patients With Atrial Fibrillation (AFib)', 'orgStudyIdInfo': {'id': 'CSA0010'}}, 'armsInterventionsModule': {'interventions': [{'name': 'dronedarone', 'type': 'DRUG', 'otherNames': ['Multaq®'], 'description': 'Pharmaceutical form is tablet and route of administration is oral'}, {'name': 'sotalol', 'type': 'DRUG', 'otherNames': ['BETAPACE®'], 'description': 'Pharmaceutical form is tablet and route of administration is oral'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91380', 'city': 'Chilly-Mazarin', 'country': 'France', 'facility': 'Sanofi-Aventis, France', 'geoPoint': {'lat': 48.71489, 'lon': 2.31638}}], 'overallOfficials': [{'name': 'Clinical Sciences and Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}