Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-02-22 @ 4:13 AM
Study NCT ID:
NCT01870804
Status:
COMPLETED
Last Update Posted:
2016-10-06
First Post:
2013-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atorvastatin Versus Rosuvastatin on Contrast Induced Acute Kidney Injury (PRATO-ACS 2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 760}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-05', 'studyFirstSubmitDate': '2013-05-30', 'studyFirstSubmitQcDate': '2013-06-05', 'lastUpdatePostDateStruct': {'date': '2016-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contrast Induced-Acute Kidney Injury', 'timeFrame': '72 hours', 'description': 'Increase in serum creatinine ≥ 0.5 mg/dl or ≥ 25 % within 72 hours of contrast medium exposure'}], 'secondaryOutcomes': [{'measure': 'Renal function at 30 days', 'timeFrame': '30 days after discharge', 'description': 'Estimation of the glomerular filtration rate in all patients at 30 days'}, {'measure': 'Cardiovascular and renal outcome', 'timeFrame': '30 days, 6 months, 12 months', 'description': 'Composite cardiovascular and renal events at follow-up including acute renal failure requiring dialysis, persistent renal damage, all-causes mortality, myocardial infarction or stroke.'}, {'measure': 'Anti-inflammatory effect of rosuvastatin and atorvastatin', 'timeFrame': 'On admission (baseline), at discharge (after 5 days) & at 30 days', 'description': 'High-sensitivity C-reactive protein (hs-CRP)will be measured on admission, at discharge and at 30 days.'}, {'measure': 'Lipid-modulatory effects of atorvastatin and rosuvastatin', 'timeFrame': 'On admission (baseline), at discharge (after 5 days) & at 30 days', 'description': 'Low density lipoprotein (LDL) levels will be determined on admission, at discharge and at 30 days.'}, {'measure': 'Myocardial Damage', 'timeFrame': 'During hospitalization (average 5 days)', 'description': 'Total cardiac biomarkers release during the index event'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Statins', 'Contrast-Induced Acute Kidney Injury', 'Periprocedural Myocardial Damage'], 'conditions': ['Acute Coronary Syndrome']}, 'referencesModule': {'references': [{'pmid': '32434204', 'type': 'DERIVED', 'citation': 'Toso A, Leoncini M, Maioli M, Tropeano F, Villani S, Bellandi F. A Prospective, Randomized, Open-Label Trial of Atorvastatin versus Rosuvastatin in the Prevention of Contrast-Induced Acute Kidney Injury, Worsened Renal Function at 30 Days, and Clinical Events After Acute Coronary Angiography: the PRATO-ACS-2 Study. Cardiorenal Med. 2020;10(5):288-301. doi: 10.1159/000506857. Epub 2020 May 20.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the project is to compare the nephro-protective effects of high-dose atorvastatin and high-dose rosuvastatin on the incidence of Contrast Induced-Acute Kidney Injury in patients with non-ST-elevation acute coronary syndromes scheduled for early invasive strategy.', 'detailedDescription': 'This is a prospective, single-centre, randomized study, designed to compare the nephro-protective effects of high-dose atorvastatin and high-dose rosuvastatin on the incidence of Contrast Induced-Acute Kidney Injury (CI-AKI). Consecutive statin-naïve patients admitted in the investigators institution for non-ST elevation Acute Coronary Syndrome (NSTE-ACS) and scheduled for early invasive strategy will be eligible.\n\nPatients are randomized into two groups: 1) high-dose rosuvastatin (40 mg on-admission followed by 20 mg/day); 2) high-dose atorvastatin (80 mg on-admission followed by 40 mg/day). Randomization will be performed on-admission by computerized open-label assignment in blinded envelopes used in a consecutive fashion. All patients receive the standard pre-procedural hydration. The primary end-point is the proportion of patients with an increase in serum creatinine of ≥ 0.5 mg/dl or ≥ 25% above baseline within 72 hours after contrast medium administration. The secondary end-points are persistent worsening of renal damage (eGFR reduction \\>= 25% at 30 days) and cumulative adverse clinical events at follow-up. Specifically: death, myocardial infarction, dialysis, stroke or persistent renal damage at 30 days; death or myocardial infarction at 6 and 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All consecutive statin-naive patients with non ST-elevation acute coronary syndrome admitted to our institution and scheduled for early invasive strategy are considered for enrollment\n\nExclusion Criteria:\n\n* Current statin treatment\n* High-risk features warranting emergency coronary angiography (within 2 hours)\n* Acute renal failure or end-stage renal failure requiring dialysis or serum creatinine ≥ 3 mg/dl\n* Severe comorbidities which precluded early invasive strategy\n* Contraindications to statin treatment\n* Contrast media administration within the last 10 days\n* Pregnancy\n* Refusal of consent'}, 'identificationModule': {'nctId': 'NCT01870804', 'acronym': 'PRATO-ACS-2', 'briefTitle': 'Atorvastatin Versus Rosuvastatin on Contrast Induced Acute Kidney Injury (PRATO-ACS 2)', 'organization': {'class': 'OTHER', 'fullName': 'Centro Cardiopatici Toscani'}, 'officialTitle': 'Impact of Early High-dose Atorvastatin Versus Rosuvastatin on Contrast Induced Acute Kidney Injury in Unselected Patients With Non- ST Elevation Acute Coronary Syndromes Scheduled for Early Invasive Strategy.', 'orgStudyIdInfo': {'id': '472013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Rosuvastatin', 'description': 'Rosuvastatin (40 mg on-admission followed by 20 mg/day) until discharge; then 20 mg/day (10 mg/day if creatinine clearance \\< 30 ml/min)', 'interventionNames': ['Drug: Rosuvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Atorvastatin', 'description': 'atorvastatin (80 mg on-admission followed by 40 mg/day before and after discharge)', 'interventionNames': ['Drug: Atorvastatin']}], 'interventions': [{'name': 'Rosuvastatin', 'type': 'DRUG', 'armGroupLabels': ['Rosuvastatin']}, {'name': 'Atorvastatin', 'type': 'DRUG', 'armGroupLabels': ['Atorvastatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59100', 'city': 'Prato', 'state': 'Prato', 'country': 'Italy', 'facility': 'Cardiology Division, Prato Hospital', 'geoPoint': {'lat': 43.8805, 'lon': 11.09699}}], 'overallOfficials': [{'name': 'Anna Toso, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prato Hospital, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Cardiopatici Toscani', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Anna Toso', 'investigatorAffiliation': 'Ospedale Misericordia e Dolce'}}}}