Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-01 @ 3:39 PM
Study NCT ID:
NCT01047566
Status:
COMPLETED
Last Update Posted:
2011-11-10
First Post:
2010-01-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Addition of Dronedarone to Standard Rate Control Therapy on Ventricular Rate During Persistent Atrial Fibrillation (AFRODITE)
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': 'D000319', 'term': 'Adrenergic beta-Antagonists'}, {'id': 'D002121', 'term': 'Calcium Channel Blockers'}, {'id': 'D004077', 'term': 'Digoxin'}], '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': 'D018674', 'term': 'Adrenergic Antagonists'}, {'id': 'D018663', 'term': 'Adrenergic Agents'}, {'id': 'D018377', 'term': 'Neurotransmitter Agents'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D049990', 'term': 'Membrane Transport Modulators'}, {'id': 'D000077264', 'term': 'Calcium-Regulating Hormones and Agents'}, {'id': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D004071', 'term': 'Digitalis Glycosides'}, {'id': 'D002298', 'term': 'Cardenolides'}, {'id': 'D002301', 'term': 'Cardiac Glycosides'}, {'id': 'D002297', 'term': 'Cardanolides'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-09', 'studyFirstSubmitDate': '2010-01-12', 'studyFirstSubmitQcDate': '2010-01-12', 'lastUpdatePostDateStruct': {'date': '2011-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ventricular rate', 'timeFrame': 'One week'}], 'secondaryOutcomes': [{'measure': 'Ventricular rate', 'timeFrame': '12 weeks'}, {'measure': 'Patients with registered AF episodes', 'timeFrame': 'Within the 12 weeks after randomization'}, {'measure': 'Patients with symptomatic AF episodes', 'timeFrame': 'Within the 12 weeks after randomization'}, {'measure': 'Severity of AF and AF-like symptoms', 'timeFrame': 'Within the 12 weeks after randomization'}, {'measure': 'Premature study discontinuation', 'timeFrame': 'Within the 12 weeks after randomization', 'description': 'Premature study discontinuation for all reasons including those where the patients must go off study prematurely as per protocol (ie. in case of cardioversion during the 1st study week, 2nd cardioversion after the 1st study week, addition of anti-arrhythmic drug, ablation or other surgical AF related intervention)'}, {'measure': 'Patients with symptomatic episodes of bradycardia', 'timeFrame': 'Within the 12 weeks after randomization'}, {'measure': 'Patients with low heart rate (<60 bpm)', 'timeFrame': 'Within the 12 weeks after randomization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to:\n\nAssess whether the addition of dronedarone to existing conventional rate control therapy leads to a reduced ventricular rate after 1 week in patients with a high Heart Rate (HR) at rest during Atrial Fibrillation (AF) in comparison to an increase of conventional therapy.\n\nThe secondary objectives of this study are to compare both study arms with regard to:\n\n* Ventricular rate after 3 months\n* Number of registered AF episodes\n* Number of symptomatic AF episodes\n* Severity of AF and AF-like symptoms\n* Rate of premature study discontinuation\n* Number of symptomatic episodes of bradycardia\n* Incidence of low heart rate (\\<60 bpm)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '46 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Persistent AF with HR \\>80 bpm at rest despite treatment with ≤ 2 rate control agents (i.e. beta blocker and/or calcium antagonist - Patients using digoxin are eligible)\n* Documented AF in the past 24 hours\n* Treated with the following rate control medication:\n* beta blocker or\n* calcium antagonist or\n* beta blocker plus calcium antagonist or\n* beta blocker plus digoxin or\n* calcium antagonist plus digoxin\n* Anticoagulant treatment in line with local guidelines\n\nExclusion Criteria:\n\n* Incapacitated patients\n* Paroxysmal or permanent AF\n* Use of class I or III anti-arrhythmic drugs in the past 12 weeks\n* Scheduled cardioversion or pulmonary vein ablation\n* Unstable New York Heart Association (NYHA) class III and all class IV Heart Failure\n* AV block grade 2 or 3\n* Known severe renal impairment (serum creatinine \\> 180 μmol/l)\n* Known severe hepatic impairment (AST, ALT \\> 3 x Upper Limit of Normal (ULN))\n* Contra-indication for dronedarone\n* Participation in a clinical drug study in the 3 months prior to inclusion\n* Women of childbearing potential, who do not use adequate contraception\n* Lactating women\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01047566', 'acronym': 'AFRODITE', 'briefTitle': 'Effect of Addition of Dronedarone to Standard Rate Control Therapy on Ventricular Rate During Persistent Atrial Fibrillation (AFRODITE)', 'nctIdAliases': ['NCT01117207'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'The Effect of the Addition of Dronedarone to, Versus Increase of, Existing Conventional Rate Control Medication on Ventricular Rate During Persistent Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'DRONE_L_05066'}, 'secondaryIdInfos': [{'id': '2009-018215-53', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Addition of dronedarone', 'description': 'Addition of Dronedarone to existing rate control medication (beta blocker and/or calcium antagonist)', 'interventionNames': ['Drug: Dronedarone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dose Increase', 'description': 'Dose increase of existing rate control medication (beta blocker or calcium antagonist or digoxin)', 'interventionNames': ['Drug: Beta blocker or calcium antagonist or digoxin']}], 'interventions': [{'name': 'Dronedarone', 'type': 'DRUG', 'otherNames': ['Multaq'], 'description': 'Pharmaceutical form: tablet Route of administration: oral Dose regimen: 400 mg twice daily for 12 weeks (+/- 5 days)', 'armGroupLabels': ['Addition of dronedarone']}, {'name': 'Beta blocker or calcium antagonist or digoxin', 'type': 'DRUG', 'description': 'Dose increase of beta blocker or calcium antagonist or digoxin', 'armGroupLabels': ['Dose Increase']}]}, 'contactsLocationsModule': {'locations': [{'city': 'PE Gouda', 'country': 'Netherlands', 'facility': 'Sanofi-Aventis Administrative Office'}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}