Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-10 @ 3:20 PM
Study NCT ID:
NCT02084069
Status:
COMPLETED
Last Update Posted:
2015-03-04
First Post:
2014-03-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Atrovastatin for Preventing Atrial Fibrillation Following Open Cardiac Valve Repair
Sponsor:
Organization:
Raw JSON
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'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The sample size of this study was small'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treatment', 'description': 'Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery', 'otherNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Control', 'description': 'Placebo', 'otherNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Postoperative bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Atrial Fibrillation Incidence After Open Cardiac Valve Repair', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery'}, {'id': 'OG001', 'title': 'Control', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 5 days after open cardiac valve repair', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', 'description': 'Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery'}, {'id': 'FG001', 'title': 'Control', 'description': 'Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment', 'description': 'Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery'}, {'id': 'BG001', 'title': 'Control', 'description': 'Placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000', 'lowerLimit': '48', 'upperLimit': '61'}, {'value': '45', 'groupId': 'BG001', 'lowerLimit': '39', 'upperLimit': '52'}, {'value': '49', 'groupId': 'BG002', 'lowerLimit': '41', 'upperLimit': '60'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Iran, Islamic Republic of', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All enrolled patients completed the study'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-13', 'studyFirstSubmitDate': '2014-03-08', 'resultsFirstSubmitDate': '2015-01-21', 'studyFirstSubmitQcDate': '2014-03-08', 'lastUpdatePostDateStruct': {'date': '2015-03-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-01-21', 'studyFirstPostDateStruct': {'date': '2014-03-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Atrial Fibrillation Incidence After Open Cardiac Valve Repair', 'timeFrame': 'Within 5 days after open cardiac valve repair'}]}, 'conditionsModule': {'conditions': ['Heart Valve Diseases']}, 'referencesModule': {'references': [{'pmid': '25540059', 'type': 'DERIVED', 'citation': 'Dehghani MR, Kasianzadeh M, Rezaei Y, Sepehrvand N. Atorvastatin Reduces the Incidence of Postoperative Atrial Fibrillation in Statin-Naive Patients Undergoing Isolated Heart Valve Surgery: A Double-Blind, Placebo-Controlled Randomized Trial. J Cardiovasc Pharmacol Ther. 2015 Sep;20(5):465-72. doi: 10.1177/1074248414564869. Epub 2014 Dec 24.'}], 'seeAlsoLinks': [{'url': 'http://umsu.ac.ir', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the investigation is to determine whether Atrovastatin as anti-inflammatory agent can be effective in preventing from atrial fibrillation incidence in patients whom undergone open cardiac surgery for their heart valve repair.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Greater than 25 y/o\n* No occurrence of intra- or post-operative cardiopulmonary arrest\n* Not consuming drugs affecting atrial rhythm\n* Having sinus rhythm before surgery\n* Lack of paroxysmal atrial fibrillation history\n* Only undergo heart valve surgery\n* Lack of considerable heart ischemia needed atorvastatin use\n* Routine cares in ward, post-operative ward, and intensive care unit were done\n\nExclusion Criteria:\n\n* Lesser than 25 y/o\n* History of atrial fibrillation\n* History of taking anti-arrhythmic drugs\n* History of implementing pacemakers\n* Severe heart failure\n* Renal failure\n* Hepatic failure\n* Severe pulmonary diseases\n* Heart block or bradyarrhythmia\n* Routine cares in ward, post-operative ward, and intensive care unit were not done\n* Performing concomitant cardiac surgery except valve repair\n* Having considerable heart ischemia needed atorvastatin use'}, 'identificationModule': {'nctId': 'NCT02084069', 'briefTitle': 'Atrovastatin for Preventing Atrial Fibrillation Following Open Cardiac Valve Repair', 'organization': {'class': 'OTHER', 'fullName': 'Urmia University of Medical Sciences'}, 'orgStudyIdInfo': {'id': 'UMSU-Cardiology-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment', 'description': 'Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery', 'interventionNames': ['Drug: Atorvastatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Placebo'}], 'interventions': [{'name': 'Atorvastatin', 'type': 'DRUG', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Urmia', 'state': 'West Azerbaijan Province', 'country': 'Iran', 'facility': 'Seyyed-al-Shohada Heart Center', 'geoPoint': {'lat': 37.55274, 'lon': 45.07605}}], 'overallOfficials': [{'name': 'Yousef Rezaei, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seyyed-al-Shohada Heart Center, Urmia University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Urmia University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}