Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT01071993
Status:
TERMINATED
Last Update Posted:
2017-12-04
First Post:
2010-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy of Statins In Prevention of CIN
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mazen-abufadel@ouhsc.edu', 'phone': '405-271-4742', 'title': 'Mazen Abu-Fadel, MD', 'organization': 'University of Oklahoma'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Study Sponsor no longer supplied study drug/placebo.'}}, 'adverseEventsModule': {'timeFrame': 'Not applicable/study was terminated prior to randomization.', 'eventGroups': [{'id': 'EG000', 'title': 'Atorvastatin', 'description': 'atorvastatin: pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'placebo: pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Endpoint. Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of > 0.5 mg/dL or >25% Increase From Baseline at 24 & at 48 Hours.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin', 'description': 'atorvastatin: pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo: pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)'}], 'timeFrame': '48 hours', 'description': 'Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of \\> 0.5 mg/dL or \\>25% Increase From Baseline at 24 \\& at 48 Hours', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants signed consent; however, study was terminated prior to randomization'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Atorvastatin', 'description': 'atorvastatin: pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'placebo: pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited and signed consent. No drugs were supplied to participants. Study sponsor could not provide study drugs to participants due to cost restraints.', 'preAssignmentDetails': 'Prior to assigning participants to specific arms of the protocol, site was informed that the study drug was no longer available.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Atorvastatin', 'description': 'atorvastatin: pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'placebo: pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years'}, {'title': 'Between 18 and 65 years'}, {'title': '>=65 years'}]}]}, {'title': 'Age, Continuous'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}]}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States'}], 'unitOfMeasure': 'participants'}], 'populationDescription': 'Participants signed consent; however, study was terminated prior to randomization.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'whyStopped': 'Sponsor can not supply drugs anymore.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-27', 'studyFirstSubmitDate': '2010-02-18', 'resultsFirstSubmitDate': '2017-04-07', 'studyFirstSubmitQcDate': '2010-02-18', 'lastUpdatePostDateStruct': {'date': '2017-12-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-14', 'studyFirstPostDateStruct': {'date': '2010-02-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Endpoint. Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of > 0.5 mg/dL or >25% Increase From Baseline at 24 & at 48 Hours.', 'timeFrame': '48 hours', 'description': 'Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of \\> 0.5 mg/dL or \\>25% Increase From Baseline at 24 \\& at 48 Hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['prevention', 'nephropathy'], 'conditions': ['Nephropathy']}, 'descriptionModule': {'briefSummary': 'To determine if statin therapy plus intravenous normal saline, in patients with chronic renal insufficiency undergoing angiography, is superior to placebo plus intravenous normal saline therapy in the prevention of CIN.', 'detailedDescription': 'Due to the conflict in the available data, there are no practice guidelines that are established in order to prevent contrast-induced nephropathy (CIN). Our goal is to determine if statin therapy plus intravenous normal saline, in patients with chronic renal insufficiency undergoing angiography, is superior to placebo plus intravenous normal saline therapy in the prevention of CIN.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '1. Inclusion Criteria:\n\n * Adults \\> 18 years of age\n * undergoing coronary or peripheral angiography with or without intervention\n * Cr \\> 1.3 mg/dL or GFR \\< 60 mL/min\n2. Exclusion Criteria:\n\n * end-stage renal disease on dialysis\n * acute renal failure\n * previous iodinated contrast media exposure within 7 days of study entry\n * history of hypersensitivity to statins\n * pregnancy or lactation\n * emergent coronary angiography, ST elevation myocardial infarction (STEMI), or cardiogenic shock\n * prisoners\n * patients already on maximum dose of statins\n * patient receiving N-acetylcysteine or sodium bicarbonate'}, 'identificationModule': {'nctId': 'NCT01071993', 'acronym': 'SCIN', 'briefTitle': 'Efficacy of Statins In Prevention of CIN', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Efficacy Of Statins In The Prevention of Contrast-Induced Nephropathy in Patients With Chronic Renal Insufficiency (SCIN Trial): A Double-Blind, Placebo-Controlled Trial', 'orgStudyIdInfo': {'id': '15097'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'atorvastatin', 'interventionNames': ['Drug: atorvastatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'placebo', 'type': 'DRUG', 'description': 'pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)', 'armGroupLabels': ['placebo']}, {'name': 'atorvastatin', 'type': 'DRUG', 'description': 'pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)', 'armGroupLabels': ['atorvastatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma University Health Science Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Mazen Abu-Fadel, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oklahoma Univeristy Health Science Center and VA Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No data was collected; therefore, a plan is not applicable.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}