Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-02-25 @ 10:05 PM
Study NCT ID:
NCT02029534
Status:
UNKNOWN
Last Update Posted:
2016-06-16
First Post:
2013-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intensive Statin Therapy Effect on Post-Operative Atrial Fibrillation (POAF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-15', 'studyFirstSubmitDate': '2013-08-16', 'studyFirstSubmitQcDate': '2014-01-06', 'lastUpdatePostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of atrial fibrillation by hospital discharge', 'timeFrame': 'Hospital discharge, an expected 5-7 days', 'description': 'Occurrence of atrial fibrillation, defined as a new diagnosis of atrial fibrillation that lasts at least 5 minutes based on telemetry or 12 lead ECG readings.'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': 'Hospital discharge, an expected 5-7 days'}, {'measure': 'Incidence of major adverse cardiac and cardiovascular events (MACCE) at 30 days', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['post-operative atrial fibrillation', 'POAF', 'A-Fib'], 'conditions': ['Cardiothoracic Surgery', 'Post-operative Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This study will compare the effects of 20 mg of atorvastatin to 80 mg of atorvastatin for the prevention of atrial fibrillation after cardiothoracic surgery. The study hypothesis is that 80 mg of atorvastatin will be more effective at preventing atrial fibrillation compared to 20 mg.', 'detailedDescription': 'This is a randomized, double-blind comparison of two doses of atorvastatin for prevention of post-operative atrial fibrillation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 19 or older\n* Undergoing elective cardiothoracic surgery\n\nExclusion Criteria:\n\n* Emergency cardiothoracic surgery\n* History of permanent atrial fibrillation\n* Acute coronary syndrome within 7 days\n* Antiarrhythmic drug use in the past 3 months\n* Receiving maximal tolerated dose of statin therapy\n* Receiving fibrate therapy\n* History of statin intolerance\n* Significant liver impairment (aspartate aminotransferase/alanine aminotransferase(AST/ALT)\\>2x ULN)\n* Serum Creatinine \\> 3 mg/dl\n* Pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT02029534', 'briefTitle': 'Intensive Statin Therapy Effect on Post-Operative Atrial Fibrillation (POAF)', 'organization': {'class': 'OTHER', 'fullName': 'Creighton University'}, 'officialTitle': 'Intensive Statin Therapy Effect on Incidence of Post-Operative Atrial Fibrillation', 'orgStudyIdInfo': {'id': '13-16729'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Atorvastatin 20 mg', 'description': 'atorvastatin 20 mg daily 2 to 7 days prior to surgery and up to 7 post surgery', 'interventionNames': ['Drug: Atorvastatin 20 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Atorvastatin 80 mg', 'description': 'atorvastatin 80 mg daily 2 to 7 days prior to surgery and up to7 days post surgery', 'interventionNames': ['Drug: Atorvastatin 80 mg']}], 'interventions': [{'name': 'Atorvastatin 20 mg', 'type': 'DRUG', 'otherNames': ['Lipitor'], 'armGroupLabels': ['Atorvastatin 20 mg']}, {'name': 'Atorvastatin 80 mg', 'type': 'DRUG', 'otherNames': ['Lipitor'], 'armGroupLabels': ['Atorvastatin 80 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68131', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aiman Smer, MBBCh', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Manu Kaushik, MBBS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Janardhana Gorthi, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Daniel E Hilleman, PharmD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hussam Abuissa, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tammy L Burns, PharmD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Aryan N Mooss, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Creighton University', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'centralContacts': [{'name': 'Caroline Nubel', 'role': 'CONTACT', 'email': 'carolinenubel@creighton.edu', 'phone': '402-280-4032'}], 'overallOfficials': [{'name': 'Aiman Smer, MBBCh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Creighton University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Creighton University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}