Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-28 @ 1:12 PM
Study NCT ID:
NCT00668759
Status:
COMPLETED
Last Update Posted:
2009-12-15
First Post:
2008-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase III Superiority Study of Vernakalant vs Amiodarone in Subjects With Recent Onset Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Bulgaria']}, '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': 'C524581', 'term': 'vernakalant'}, {'id': 'D000638', 'term': 'Amiodarone'}], 'ancestors': [{'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 254}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-12', 'studyFirstSubmitDate': '2008-04-25', 'studyFirstSubmitQcDate': '2008-04-28', 'lastUpdatePostDateStruct': {'date': '2009-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects with conversion of atrial fibrillation to sinus rhythm within 90 minutes after the start of infusion.', 'timeFrame': 'Conversion of AF to SR for a minimum duration of one minute within 90 minutes after start of infusion.'}], 'secondaryOutcomes': [{'measure': 'Time to conversion within 90 minutes after the start of infusion.', 'timeFrame': 'Time to conversion of AF to SR within 90 minutes after start of infusion.'}, {'measure': 'Proportion of subjects with symptom relief at 90 minutes after the start of infusion.', 'timeFrame': 'Relief of AF symptoms 90 minutes after start of infusion.'}, {'measure': 'EQ-5D quality of life assessment.', 'timeFrame': 'Assessment of quality of life 2 hours after start of infusion.'}, {'measure': 'Monitoring of adverse events, vital signs, continuous telemetry monitoring, 12-lead Holter monitoring, 12-lead ECGs, and laboratory tests.', 'timeFrame': 'Specified safety assessments completed at specified time points throughout the study from Screening to Discharge, at the Day 7 visit, and at the Day 30 follow-up call.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'atrial fib', 'AF'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '21232669', 'type': 'DERIVED', 'citation': 'Camm AJ, Capucci A, Hohnloser SH, Torp-Pedersen C, Van Gelder IC, Mangal B, Beatch G; AVRO Investigators. A randomized active-controlled study comparing the efficacy and safety of vernakalant to amiodarone in recent-onset atrial fibrillation. J Am Coll Cardiol. 2011 Jan 18;57(3):313-21. doi: 10.1016/j.jacc.2010.07.046.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to demonstrate the superiority of vernakalant injection over amiodarone injection in the conversion of atrial fibrillation (AF) to sinus rhythm (SR) within 90 minutes of the start of drug administration. The secondary objective is to compare the safety of vernakalant to amiodarone.', 'detailedDescription': "This is a double-blind, active-controlled, double-dummy, multi-center, randomized trial in subjects with symptomatic AF of 3 to 48 hours duration.\n\nSubjects will be randomized to receive vernakalant injection or amiodarone injection in a 1:1 ratio.\n\nSafety will be assessed through the monitoring of adverse events, vital signs, continuous telemetry monitoring, 12-lead Holter monitoring, 12-lead ECGs, and laboratory tests.\n\nAt 2 hours after the start of infusion, electrical cardioversion may be performed or rate control medication may be administered. Class I and Class III antiarrhythmics are not to be administered for 24 hours after the start of infusion.\n\nSubjects are to remain in the clinic for at least 6 hours after the start of infusion. Subjects will attend a follow-up visit at 7 (±2) days after treatment and will receive a follow-up telephone call at 30 (±3) days for assessment of serious adverse events, concomitant medications related to serious adverse events, and recurrence of AF.\n\nAll roles were blinded with the exception of each site's designated unblinded personnel who were responsible for randomization and preparation, dispensation and accountability of the study medication.\n\nExpanded Access was not available through this protocol."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Have symptomatic AF of 3 to 48 hours duration at baseline.\n* Be eligible for cardioversion.\n* Have adequate anticoagulation therapy for cardioversion in accordance with standard of practice as recommended by ACC/AHA/ESC guidelines \\[1\\].\n* Be hemodynamically stable and have systolic blood pressure (BP) above 100 mmHg and less than 160 mmHg and diastolic BP less than 95 mmHg at screening and baseline.\n\nKey Exclusion Criteria:\n\n* Known or suspected prolonged QT or uncorrected QT interval of \\>440 msec as measured at screening on a 12 lead ECG, familial long QT syndrome, or previous torsades de pointes, ventricular fibrillation; or sustained ventricular tachycardia (VT).\n* Symptomatic bradycardia, sick sinus syndrome, or ventricular rate less than 50 beats per minute (bpm) as documented by 12-lead ECG at screening.\n* A QRS interval \\>140 msec.\n* Atrial flutter.\n* Significant valvular stenosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis.\n* Documented previous episodes of second or third degree atrioventricular (AV) block.\n* Had a myocardial infarction (MI), acute coronary syndrome or cardiac surgery within 30 days prior to entry into the study.\n* Uncorrected electrolyte imbalance of serum potassium or magnesium. Both K+ and Mg2+ must be corrected prior to dosing.'}, 'identificationModule': {'nctId': 'NCT00668759', 'acronym': 'AVRO', 'briefTitle': 'A Phase III Superiority Study of Vernakalant vs Amiodarone in Subjects With Recent Onset Atrial Fibrillation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Advanz Pharma'}, 'officialTitle': 'A Phase III Prospective, Randomized, Double-Blind, Active-Controlled, Multi-Center, Superiority Study of Vernakalant Injection Versus Amiodarone in Subjects With Recent Onset Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'VERI-305-AMIO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Vernakalant Injection:\n\nIn one infusion line, subjects will receive a 10-minute infusion of vernakalant followed by a 15-minute observation period, followed by an additional 10-minute infusion of vernakalant if required (if the subject is still in AF). To maintain blinding, a 60-minute infusion of placebo (D5W) will be administered in a second infusion line, followed by a maintenance infusion of placebo for a minimum of an additional 60 minutes.', 'interventionNames': ['Drug: Vernakalant Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Amiodarone Injection:\n\nIn one infusion line subjects will receive a 60-minute infusion of amiodarone followed by a maintenance infusion of amiodarone over an additional 60 minutes. To maintain blinding, a 10-minute infusion of placebo (normal saline) will be administered in a second infusion line, followed by a 15 minute observation period, followed by a 10 minute infusion of placebo if the subject is still in AF.', 'interventionNames': ['Drug: Amiodarone Injection:']}], 'interventions': [{'name': 'Vernakalant Injection', 'type': 'DRUG', 'otherNames': ['RSD1235', 'Kynapid'], 'description': '10-minute infusion of 3 mg/kg vernakalant injection followed by a 15-minute observation period, followed by an additional 10-minute infusion of 2 mg/kg of vernakalant if required (if the subject is still in AF).', 'armGroupLabels': ['1']}, {'name': 'Amiodarone Injection:', 'type': 'DRUG', 'otherNames': ['Amiodarone', 'Cordarone'], 'description': '60-minute infusion of 5 mg/kg amiodarone followed by a maintenance infusion of 50 mg amiodarone over an additional 60 minutes (equivalent to approximately 15 mg/kg over 24 hrs).', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '7000', 'city': 'Hobart', 'state': 'Tasmania', 'country': 'Australia', 'facility': 'Royal Hobart Hospital Cardiology Research', 'geoPoint': {'lat': -42.87936, 'lon': 147.32941}}, {'city': 'Launceston', 'state': 'Tasmania', 'country': 'Australia', 'facility': 'Launceston General Hospital Cardiac Research Unit', 'geoPoint': {'lat': -41.43876, 'lon': 147.13467}}, {'zip': '6000', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Royal Perth Hospital Emergency Research', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': 'K7L 2V7', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Kingston General Hospital', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'K1Y 4E9', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'H7M 3L9', 'city': 'Laval', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital de la Cite-de-la-Sante', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}, {'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institut de Cardiologie de Montreal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2W 1T8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre Hopitalier de L'Universite de Montreal - Hotel Dieu", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3G 1A4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University Health Center The Montreal General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'J6V 2H2', 'city': 'Terrebonne', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre de santé et de services sociaux du Sud de Lanaudière - Hôpital Pierre-Le Gardeur', 'geoPoint': {'lat': 45.70004, 'lon': -73.64732}}, {'zip': '286 01', 'city': 'Čáslav', 'country': 'Czechia', 'facility': 'Mestrska nemocnice Caslav', 'geoPoint': {'lat': 49.91099, 'lon': 15.38972}}, {'zip': '767 55', 'city': 'Kroměříž', 'country': 'Czechia', 'facility': 'Nemocnice Kroměříž', 'geoPoint': {'lat': 49.29785, 'lon': 17.39312}}, {'city': 'Kutná Hora', 'country': 'Czechia', 'facility': 'Nemocnice Kutna Hora s.r.o. 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