Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-27 @ 11:18 PM
Study NCT ID:
NCT01245894
Status:
COMPLETED
Last Update Posted:
2010-11-23
First Post:
2010-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-22', 'studyFirstSubmitDate': '2010-11-22', 'studyFirstSubmitQcDate': '2010-11-22', 'lastUpdatePostDateStruct': {'date': '2010-11-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint was the change from baseline in Index of microcirculatory resistance(IMR).', 'timeFrame': 'One year'}], 'secondaryOutcomes': [{'measure': 'The secondary endpoints were the changes from baseline in Fractional Flow Reserve (FFR) and lipid values.', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Index of microcirculatory resistance', 'Fractional Flow Reserve'], 'conditions': ['Myocardial Infarction [C14.907.585.500]']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to measure the effect of low- and high-dose lipid-lowering treatment with rosuvastatin on the coronary physiology parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '81 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ST-segment elevation myocardial infarction\n2. no prior treatment with statins and\n3. a non significant lesion in one of the two non-culprit coronary arteries\n\nExclusion Criteria:\n\n1. age below 18 or above 81 years,\n2. unconscious patients,\n3. serum creatinine \\> 176μmol/L,\n4. hypothyroidism ((TSH \\> 1.5 x ULN (upper limit of normal)),\n5. current liver disease (ALAT \\> 2 x ULN),\n6. unexplained creatine kinase \\> 3 x ULN,\n7. alcohol or drug abuse within the last five years,\n8. prior myopathy or serious hypersensitivity reaction caused by statins,\n9. women with childbearing potential who were not using chemical or mechanical contraception,\n10. pregnant or breastfeeding women,\n11. history of malignancy unless a disease-free period of more than five years was present,\n12. patients with abnormal lung function test (LFT),\n13. participation in another investigational drug study less than four weeks before enrolment in the present study,\n14. treatment with cyclosporine or fibrates'}, 'identificationModule': {'nctId': 'NCT01245894', 'briefTitle': 'Influence of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on the Coronary Microcirculation', 'orgStudyIdInfo': {'id': 'VF-20060'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Low-dose Rosuvastatin', 'description': '5mg Rosuvastatin/day', 'interventionNames': ['Drug: Low-dose Rosuvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High-dose Rosuvastatin', 'description': 'Rosuvastatin 40mg/day', 'interventionNames': ['Drug: High-dose Rosuvastatin']}], 'interventions': [{'name': 'Low-dose Rosuvastatin', 'type': 'DRUG', 'otherNames': ['Crestor'], 'description': 'Rosuvastatin 5mg/day for one year', 'armGroupLabels': ['Low-dose Rosuvastatin']}, {'name': 'High-dose Rosuvastatin', 'type': 'DRUG', 'otherNames': ['Crestor'], 'description': 'Rosuvastatin 40mg/day for one year', 'armGroupLabels': ['High-dose Rosuvastatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'state': 'Fuenen', 'country': 'Denmark', 'facility': 'Department of Cardiology, Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Rasmus Egede, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cardiology, Odense University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'MD Rasmus Egede', 'oldOrganization': 'Department of Cardiology, Odense University Hospital'}}}}