Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT00905905
Status:
COMPLETED
Last Update Posted:
2010-03-24
First Post:
2009-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Additive Effect of Ezetimibe Upon Simvastatin During Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019821', 'term': 'Simvastatin'}, {'id': 'D019161', 'term': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'}, {'id': 'D000069499', 'term': 'Ezetimibe, Simvastatin Drug Combination'}], 'ancestors': [{'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000924', 'term': 'Anticholesteremic Agents'}, {'id': 'D000960', 'term': 'Hypolipidemic Agents'}, {'id': 'D000963', 'term': 'Antimetabolites'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D057847', 'term': 'Lipid Regulating Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D000069438', 'term': 'Ezetimibe'}, {'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-23', 'studyFirstSubmitDate': '2009-05-20', 'studyFirstSubmitQcDate': '2009-05-20', 'lastUpdatePostDateStruct': {'date': '2010-03-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'C- reactive Protein (CRP) elevation during the first 7 days after myocardial infarction', 'timeFrame': '5th day'}], 'secondaryOutcomes': [{'measure': 'Endothelial function 30 days after myocardial infarction', 'timeFrame': '30th day'}, {'measure': 'Stress Insulin Resistance', 'timeFrame': '5th day', 'description': 'Evaluation of the change in plasma glucose, insulin and C-peptide from admission to the fifth day after myocardial infarction'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['myocardial infarction', 'systemic inflammatory activity', 'endothelial function'], 'conditions': ['Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'During acute coronary syndromes (ACS), the generation of inflammatory mediators negatively influences arterial wall remodeling and the endothelium-dependent vasomotor function in the coronary and systemic arterial systems. In fact, the intensity of the inflammatory upregulation is strongly related to the incidence of recurrent coronary events. The investigators previously demonstrated that high dose potent statins can rapidly reduce plasma levels of cholesterol-rich lipoproteins and inflammatory activity in subjects during ACS. In addition, such statin treatment attenuates the post-discharge endothelial dysfunction of these patients. By inference, it is plausible to hypothesize that these beneficial effects during ACS may be intensified by an additive lowering of plasma cholesterol through the treatment with ezetimibe. So far, data is unavailable to verify this assumption. In parallel, data from animal models have suggested that both statins and ezetimibe may reduce insulin sensitivity by their effect on cholesterol content and, by this way, on insulin signaling in liver cells. In this context, the present study aims to investigate the role of the addition of ezetimibe upon statin treatment on stress-induced insulin resistance and on the time-course of the inflammatory response during the acute phase of myocardial infarction and its late effect on endothelium-dependent arterial dilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* less than 24 hours after the onset of myocardial infarction symptoms\n* ST-segment elevation of a least 1 mm (frontal plane) or 2 mm (horizontal plane) in two contiguous leads\n* myocardial necrosis, as evidenced by increased CK-MB and troponin levels\n\nExclusion Criteria:\n\n* use of statins for the last 6 months before myocardial infarction'}, 'identificationModule': {'nctId': 'NCT00905905', 'briefTitle': 'Additive Effect of Ezetimibe Upon Simvastatin During Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Brasilia Heart Study Group'}, 'officialTitle': 'Additive Effect of Ezetimibe Upon Simvastatin Treatment on Systemic Inflammatory Activity and Endothelial Function During Myocardial Infarction', 'orgStudyIdInfo': {'id': 'EMI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ezetimibe-Simvastatin 10/40 mg', 'interventionNames': ['Drug: Ezetimibe-Simvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Simvastatin 40 mg', 'interventionNames': ['Drug: Simvastatin']}], 'interventions': [{'name': 'Simvastatin', 'type': 'DRUG', 'otherNames': ['Statin', 'Zocor'], 'description': 'Simvastatin 40 mg/day during the first 7 days and then 20 mg/day for 3 more weeks until the evaluation of flow-mediated brachial artery dilation', 'armGroupLabels': ['Simvastatin 40 mg']}, {'name': 'Ezetimibe-Simvastatin', 'type': 'DRUG', 'otherNames': ['Vytorin'], 'description': 'Ezetimibe-Simvastatin 10-40 mg/day during the first 7 days and then 20 mg/day for 3 more weeks until the evaluation of flow-mediated brachial artery dilation', 'armGroupLabels': ['Ezetimibe-Simvastatin 10/40 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70673103', 'city': 'BrasÃlia', 'state': 'Federal District', 'country': 'Brazil', 'facility': 'Hospital de Base do Distrito Federal', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}], 'overallOfficials': [{'name': 'Andrei C Sposito, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Brasilia Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brasilia Heart Study Group', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Andrei C. Sposito', 'oldOrganization': 'University of Brasilia Medical School'}}}}