Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-29 @ 5:08 AM
Study NCT ID:
NCT01187992
Status:
TERMINATED
Last Update Posted:
2010-08-25
First Post:
2010-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Full-dose Atorvastatin After Acute Coronary Syndrome (ACS) in Non-revascularisable Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 290}}, 'statusModule': {'whyStopped': 'Interim analysis showed significant effect in favour of full-dose atorvastatin.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-24', 'studyFirstSubmitDate': '2010-08-24', 'studyFirstSubmitQcDate': '2010-08-24', 'lastUpdatePostDateStruct': {'date': '2010-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse cardiovascular events', 'timeFrame': '12 months', 'description': 'The primary end point of the study was prospectively defined as the combination of cardiovascular death, non-fatal acute myocardial re-infarction (re-AMI) and disabling non-fatal stroke.'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular mortality', 'timeFrame': '12 months'}, {'measure': 'Non-fatal acute myocardial re-infarction (re-AMI)', 'timeFrame': '12 months'}, {'measure': 'Disabling non-fatal stroke', 'timeFrame': '12 months'}, {'measure': 'New-onset heart failure', 'timeFrame': '12 months'}, {'measure': 'Atrial fibrillation', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Atorvastatin', 'Acute coronary syndrome', 'Advanced coronary artery disease'], 'conditions': ['Acute Coronary Syndrome', 'Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '20367555', 'type': 'RESULT', 'citation': 'Colivicchi F, Tubaro M, Mocini D, Genovesi Ebert A, Strano S, Melina G, Uguccioni M, Santini M. Full-dose atorvastatin versus conventional medical therapy after non-ST-elevation acute myocardial infarction in patients with advanced non-revascularisable coronary artery disease. Curr Med Res Opin. 2010 Jun;26(6):1277-84. doi: 10.1185/03007991003751496.'}]}, 'descriptionModule': {'briefSummary': 'This study was designed to test the hypothesis that the addition of full-dose atorvastatin (80 mg/day) to conventional medical treatment could reduce ischaemic recurrences after non-ST-elevation acute myocardial infarction (NSTE-AMI) in patients with severe and diffuse coronary artery disease (CAD) not amenable to any form of mechanical revascularisation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non-ST-segment elevation acute myocardial infarction.\n* coronary angiography within 48 hours from admission.\n* angiographic evidence of severe and diffuse coronary artery disease,not amenable to conventional direct revascularisation techniques by coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI).\n\nExclusion Criteria:\n\n* ST-segment elevation acute myocardial infarction,\n* clinical history of heart failure\n* left ventricular ejection fraction \\<35%,\n* any form of severe valvular dysfunction,\n* previous implantation or indication to implant a cardioverter-defibrillator during the index admission,\n* any increase in liver enzymes,\n* history of any liver or muscle disease,\n* renal failure with serum creatinine \\>2.5 mg/dL (221 mmol/L),\n* need for continued use of intravenous medications to relieve anginal symptoms,\n* presence of any major comorbidity with life expectancy \\<24 months.'}, 'identificationModule': {'nctId': 'NCT01187992', 'acronym': 'APRIRE', 'briefTitle': 'Full-dose Atorvastatin After Acute Coronary Syndrome (ACS) in Non-revascularisable Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'San Filippo Neri General Hospital'}, 'officialTitle': 'Full-dose Atorvastatin Versus Conventional Medical Therapy After Non-ST-elevation Acute Myocardial Infarction in Patients With Advanced Non-revascularisable Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'SFN/02/03/AL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Full-dose atorovastatin (80 mg/d)', 'description': 'For patients randomised to this arm, atorvastatin in the fixed dose of 80 mg/ day was started immediately after randomisation.', 'interventionNames': ['Drug: Atorvastatin']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional medical treatment', 'description': 'For patients randomised to this arm, adherence to the National Cholesterol Education Program, Adult Treatment Panel III guidelines was required. In particular, in these patients,atorvastatin was started at the initial dosage of 20 mg/day immediately after randomisation. Subsequently, atorvastatin dosage was titrated in order to attain low-density lipoprotein cholesterol (LDL-C) levels \\<100 mg/dL (2.5 mmol/L).'}], 'interventions': [{'name': 'Atorvastatin', 'type': 'DRUG', 'description': '80 mg/day', 'armGroupLabels': ['Full-dose atorovastatin (80 mg/d)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'I-00135', 'city': 'Rome', 'state': 'Italy', 'country': 'Italy', 'facility': 'San Filippo Neri General Hospital', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Furio Colivicchi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Quality Mangement Unit, San Filippo Neri Hospital, Rome, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Filippo Neri General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Associazione Nazionale Medici Cardiologi Ospedalieri', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Prof. Furio Colivicchi, MD, FESC', 'oldOrganization': 'Clinical Quality management Unit, Cardiovascular Department, San Filippo Neri Hospital, Rome Italy'}}}}