Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-26 @ 4:01 AM
Study NCT ID:
NCT00257959
Status:
COMPLETED
Last Update Posted:
2006-07-27
First Post:
2005-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Pharmacological Therapy In Implantable Defibrillator Patients (OPTIC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017180', 'term': 'Tachycardia, Ventricular'}], 'ancestors': [{'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-11', 'completionDateStruct': {'date': '2004-10'}, 'lastUpdateSubmitDate': '2006-07-26', 'studyFirstSubmitDate': '2005-11-22', 'studyFirstSubmitQcDate': '2005-11-22', 'lastUpdatePostDateStruct': {'date': '2006-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ICD shock for any cause'}]}, 'conditionsModule': {'conditions': ['Ventricular Tachycardia']}, 'referencesModule': {'references': [{'pmid': '16403928', 'type': 'RESULT', 'citation': 'Connolly SJ, Dorian P, Roberts RS, Gent M, Bailin S, Fain ES, Thorpe K, Champagne J, Talajic M, Coutu B, Gronefeld GC, Hohnloser SH; Optimal Pharmacological Therapy in Cardioverter Defibrillator Patients (OPTIC) Investigators. Comparison of beta-blockers, amiodarone plus beta-blockers, or sotalol for prevention of shocks from implantable cardioverter defibrillators: the OPTIC Study: a randomized trial. JAMA. 2006 Jan 11;295(2):165-71. doi: 10.1001/jama.295.2.165.'}, {'pmid': '16818810', 'type': 'RESULT', 'citation': 'Hohnloser SH, Dorian P, Roberts R, Gent M, Israel CW, Fain E, Champagne J, Connolly SJ. Effect of amiodarone and sotalol on ventricular defibrillation threshold: the optimal pharmacological therapy in cardioverter defibrillator patients (OPTIC) trial. Circulation. 2006 Jul 11;114(2):104-9. doi: 10.1161/CIRCULATIONAHA.106.618421. Epub 2006 Jul 3.'}]}, 'descriptionModule': {'briefSummary': 'This is an open parallel design randomized trial of amiodarone plus a beta blocker vs a beta blocker alone vs sotalol for the prevention of ICD shocks in patients receiving an ICD for spontaneous or inducible ventricular tachycardia or fibrillation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: spontaneous or inducible ventricular tachycardia or fibrillation -\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00257959', 'briefTitle': 'Optimal Pharmacological Therapy In Implantable Defibrillator Patients (OPTIC)', 'organization': {'class': 'INDIV', 'fullName': 'Connolly, Stuart, M.D.'}, 'orgStudyIdInfo': {'id': '1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'amiodarone beta blocker sotalol', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster University', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Stuart Connolly', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Connolly, Stuart, M.D.', 'class': 'INDIV'}, 'collaborators': [{'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}]}}}