Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT00906451
Status:
COMPLETED
Last Update Posted:
2011-06-23
First Post:
2009-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Simvastatin Effect on Inflammation and Endothelial Function After Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D007249', 'term': 'Inflammation'}], '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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-21', 'studyFirstSubmitDate': '2009-05-19', 'studyFirstSubmitQcDate': '2009-05-20', 'lastUpdatePostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Elevation of plasma C reactive protein', 'timeFrame': 'Five days', 'description': 'Changes in CRP levels between the first and fifth day after myocardial infarction'}], 'secondaryOutcomes': [{'measure': 'Brachial Artery Endothelial function', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['myocardial infarction', 'inflammation', 'endothelial dysfunction'], 'conditions': ['Myocardial Infarction', 'Inflammation', 'Endothelial Dysfunction']}, 'referencesModule': {'references': [{'pmid': '21372302', 'type': 'RESULT', 'citation': 'Sposito AC, Santos SN, de Faria EC, Abdalla DS, da Silva LP, Soares AA, Japiassu AV, Quinaglia e Silva JC, Ramires JA, Coelho OR. Timing and dose of statin therapy define its impact on inflammatory and endothelial responses during myocardial infarction. Arterioscler Thromb Vasc Biol. 2011 May;31(5):1240-6. doi: 10.1161/ATVBAHA.110.218685. Epub 2011 Mar 3.'}]}, 'descriptionModule': {'briefSummary': 'During myocardial infarction, inflammatory response may negatively influence ventricle wall remodeling as well as endothelium-dependent vasomotor function in the coronary and systemic arterial systems. Statins have been consistently proved to attenuate inflammation and improve endothelial function. In this study, we tested the effect of different doses of statin on inflammatory response and endothelium-dependent vasodilation.', 'detailedDescription': '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. The intensity of this inflammatory upregulation is strongly related to the incidence of recurrent coronary events. High dose potent statins can rapidly reduce plasma levels of cholesterol-rich lipoproteins and inflammatory activity in subjects during ACS. By inference, it is plausible to hypothesize that these effects during the acute phase of myocardial infarction may influence the post-discharge endothelial dysfunction. So far, data is unavailable to verify this assumption or to define the potency required for such statin anti-inflammatory effect in myocardial infarction patients. The present study aim to investigate the role of statin dose 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': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Less than 24 hours after the onset of MI 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 at least 6 months prior the myocardial infarction'}, 'identificationModule': {'nctId': 'NCT00906451', 'briefTitle': 'Simvastatin Effect on Inflammation and Endothelial Function After Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Brasilia Heart Study Group'}, 'officialTitle': 'Phase 4 Study of the Effect of Simvastatin Treatment on Inflammatory Response and Endothelial Function After Myocardial Infarction', 'orgStudyIdInfo': {'id': 'Simvastatin Post-MI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No lipid-lowering', 'description': 'No lipid-lowering treatment during the first 7 days and then simvastatin 20 mg/day for three additional weeks, till the endothelial function assessment', 'interventionNames': ['Drug: Simvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'Simvastatin 20 mg', 'description': 'Simvastatin 20 mg/day for 30 days, till the endothelial function assessment', 'interventionNames': ['Drug: Simvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'Simvastatin 40 mg', 'description': 'Simvastatin 40 mg/day for 7 days and then switched to simvastatin 20mg/day for additional 3 weeks, till the endothelial function assessment', 'interventionNames': ['Drug: Simvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'Simvastatin 80 mg', 'description': 'Simvastatin 80 mg/day for 7 days and then switched to simvastatin 20 mg/day for additional 3 weeks, till the endothelial function assessment', 'interventionNames': ['Drug: Simvastatin']}], 'interventions': [{'name': 'Simvastatin', 'type': 'DRUG', 'description': 'Simvastatin', 'armGroupLabels': ['No lipid-lowering', 'Simvastatin 20 mg', 'Simvastatin 40 mg', 'Simvastatin 80 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70000000', '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'}}}}