Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-30 @ 5:50 AM
Study NCT ID:
NCT01627106
Status:
WITHDRAWN
Last Update Posted:
2013-08-26
First Post:
2012-06-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Comparing Vernakalant Therapy to Amiodarone Therapy in Acute Management of Recent Onset Atrial Fibrillation (AF) (MK-6621-055)
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': '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-08-23', 'studyFirstSubmitDate': '2012-06-21', 'studyFirstSubmitQcDate': '2012-06-21', 'lastUpdatePostDateStruct': {'date': '2013-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants discharged from the emergency room (ER) to home, home-equivalent, or long-term care facility (LTCF) within 12 hours from randomization', 'timeFrame': 'Up to 12 hours from randomization'}], 'secondaryOutcomes': [{'measure': 'Number of participants admitted to hospital directly from the ER after randomization', 'timeFrame': 'Day 1 (time of ramdomization)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This study will compare vernakalant therapy to amiodarone therapy in the acute management of recent onset atrial fibrillation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic AF (duration of current episode is ≤7 days), which is hemodynamically stable, and participant has no other condition at the time of screening that may result in acute hospitalization\n* If female and of reproductive potential, the patient agrees to remain abstinent or use 2 acceptable methods of birth control from time of screening until 30-day follow-up.\n* Weigh at least 45 kg\n* Receiving adequate anticoagulant therapy\n\nExclusion Criteria:\n\n* Hypersensitivity to the vernakalant or amiodarone or to citric acid, sodium chloride, sodium hydroxide, or iodine\n* Severe aortic stenosis\n* Systolic blood pressure \\<100 mmHg\n* New York Heart Association (NYHA) Class III or IV heart failure\n* Severe bradycardia, sinus node dysfunction, or second and third degree heart block in the absence of a pacemaker\n* Use of IV rhythm control anti-arrhythmics (Class I and III) within 4 hours of study drug administration\n* Acute coronary syndrome (including myocardial infarction) within previous 30 days\n* History of thyroid dysfunction\n* Severe acute respiratory failure or cardiovascular collapse\n* Participating in another drug study or has received an investigational drug within 30 days prior to enrollment\n* Pregnant or breast-feeding, or expecting to conceive from time of screening until 30-day follow-up'}, 'identificationModule': {'nctId': 'NCT01627106', 'briefTitle': 'A Study Comparing Vernakalant Therapy to Amiodarone Therapy in Acute Management of Recent Onset Atrial Fibrillation (AF) (MK-6621-055)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Advanz Pharma'}, 'officialTitle': 'A Multicentered, Randomized, Open-Label, Pragmatic Use Study Comparing Vernakalant Therapy to Amiodarone Therapy in Acute Management of Recent Onset Atrial Fibrillation', 'orgStudyIdInfo': {'id': '6621-055'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vernakalant', 'interventionNames': ['Drug: Vernakalant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Amiodarone', 'interventionNames': ['Drug: Amiodarone']}], 'interventions': [{'name': 'Vernakalant', 'type': 'DRUG', 'otherNames': ['Brinavess'], 'description': 'Initial intravenous (IV) dose of 3 mg/kg (up to a maximum of 339 mg) over 10 minutes, followed by a 15 minute observation period and, if conversion to sinus rhythm does not occur within 15 minutes of the initial infusion, a second 10 minute infusion of vernakalant at a dose of 2 mg/kg (up to a maximum of 226 mg) will be administered.', 'armGroupLabels': ['Vernakalant']}, {'name': 'Amiodarone', 'type': 'DRUG', 'otherNames': ['Pacerone', 'Cordarone'], 'description': 'Administered IV as per product label', 'armGroupLabels': ['Amiodarone']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Advanz Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}