Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT00127218
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2005-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
High-Density Lipoprotein (HDL) Cholesterol Increased Plaque Stabilization in the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D058226', 'term': 'Plaque, Atherosclerotic'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077340', 'term': 'Fluvastatin'}, {'id': 'D017035', 'term': 'Pravastatin'}, {'id': 'D019821', 'term': 'Simvastatin'}, {'id': 'D000069499', 'term': 'Ezetimibe, Simvastatin Drug Combination'}, {'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D009525', 'term': 'Niacin'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'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': 'D008148', 'term': 'Lovastatin'}, {'id': 'D000069438', 'term': 'Ezetimibe'}, {'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jlima@jhmi.edu', 'phone': '410-614-1284', 'title': 'Dr. Joao AC Lima', 'organization': 'The Johns Hopkins Hospital, Department of Medicine, Division of Cardiology'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Niacin Plus Statin', 'description': 'Extended release niacin (1500 mg daily) plus statin therapy to reach their National Cholesterol Education Program-defined low density lipoprotein (LDL)cholesterol target', 'otherNumAtRisk': 72, 'otherNumAffected': 5, 'seriousNumAtRisk': 72, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo Plus Statin', 'description': 'placebo plus statin therapy to reach their National Cholesterol Education Program-defined low density lipoprotein (LDL)cholesterol target', 'otherNumAtRisk': 73, 'otherNumAffected': 2, 'seriousNumAtRisk': 73, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Coronary Revascularization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in Plaque Architecture and Composition Directly Measured by Magnetic Resonance Imaging (MRI) in the Aorta and Carotid Arteries', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Niacin Plus Statin', 'description': 'Extended release niacin (1500 mg daily) plus statin therapy to reach their National Cholesterol Education Program-defined low density lipoprotein (LDL)cholesterol target'}, {'id': 'OG001', 'title': 'Placebo Plus Statin', 'description': 'placebo plus statin therapy to reach their National Cholesterol Education Program-defined low density lipoprotein (LDL)cholesterol target'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'spread': '.2', 'groupId': 'OG000'}, {'value': '5', 'spread': '.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': 'The primary endpoint is Changes in plaque architecture and composition directly measured by magnetic resonance imaging (MRI) in the aorta and carotid arteries.', 'unitOfMeasure': 'percentage of internal carotid artery', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Multiple Combined Events ( Cardiovascular and Cerebrovascular Events as Well as Myocardial Revascularization)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Statin Plus Niacin', 'description': 'any statin plus niacin\n\nany statin: Participants will be provided a prescription for fluvastatin 80 mg to be taken on a daily basis, or they may continue their ongoing or any other cholesterol-lowering drugs such as pravastatin 80 mg daily, simvastatin 20 mg daily, atorvastatin up to 20 mg daily or rosuvastatin up to 20 mg daily for 18 months\n\nniacin: long-acting niacin daily for 18 months'}, {'id': 'OG001', 'title': 'Any Statin Plus Placebo', 'description': 'any statin plus placebo\n\nany statin: Participants will be provided a prescription for fluvastatin 80 mg to be taken on a daily basis, or they may continue their ongoing or any other cholesterol-lowering drugs such as pravastatin 80 mg daily, simvastatin 20 mg daily, atorvastatin up to 20 mg daily or rosuvastatin up to 20 mg daily for 18 months\n\nPlacebo: matching placebo pill daily for 18 months'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '18 months', 'description': 'Cerebrovascular events (newly diagnosed) such as Stroke and Myocardial revascularization (specifically coronary artery bypass grafting, percutaneous coronary interventions, carotid endarterectomy) were recorded', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Cardiovascular event (stroke) was seen in only 1 patient and 5 patients needed myocardial revascularization'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Niacin Plus Statin', 'description': 'Extended release niacin (1500 mg daily) plus statin therapy to reach their National Cholesterol Education Program-defined low density lipoprotein (LDL)cholesterol target'}, {'id': 'FG001', 'title': 'Placebo Plus Statin', 'description': 'placebo plus statin therapy to reach their National Cholesterol Education Program-defined low density lipoprotein (LDL)cholesterol target'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}]}]}], 'recruitmentDetails': 'Participants were randomized in a 1:1 ratio to receive niacin or placebo, using a random number schema stratified to ensure equal numbers between age 65-74 years and 75 years and above. Study took place in a university outpatient center.', 'preAssignmentDetails': 'Participants were over age 65 years with a history of cardiovascular events or evidence of atherosclerosis at angiography (\\>50% stenosis) or non-invasive imaging, with baseline LDL\\<3.24 mmol/L if already on statin therapy and \\<3.89 mmol/L if untreated. There were no restrictions on HDL level.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Niacin Plus Statin', 'description': 'Extended release niacin (1500 mg daily) plus statin therapy to reach their National Cholesterol Education Program-defined low density lipoprotein (LDL)cholesterol target'}, {'id': 'BG001', 'title': 'Placebo Plus Statin', 'description': 'placebo plus statin therapy to reach their National Cholesterol Education Program-defined low density lipoprotein (LDL)cholesterol target'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000', 'lowerLimit': '69', 'upperLimit': '77'}, {'value': '72', 'groupId': 'BG001', 'lowerLimit': '69', 'upperLimit': '77'}, {'value': '73', 'groupId': 'BG002', 'lowerLimit': '69', 'upperLimit': '77'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 145}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-04', 'studyFirstSubmitDate': '2005-08-03', 'resultsFirstSubmitDate': '2015-09-01', 'studyFirstSubmitQcDate': '2005-08-03', 'lastUpdatePostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-10-12', 'studyFirstPostDateStruct': {'date': '2005-08-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Plaque Architecture and Composition Directly Measured by Magnetic Resonance Imaging (MRI) in the Aorta and Carotid Arteries', 'timeFrame': '18 months', 'description': 'The primary endpoint is Changes in plaque architecture and composition directly measured by magnetic resonance imaging (MRI) in the aorta and carotid arteries.'}], 'secondaryOutcomes': [{'measure': 'Multiple Combined Events ( Cardiovascular and Cerebrovascular Events as Well as Myocardial Revascularization)', 'timeFrame': '18 months', 'description': 'Cerebrovascular events (newly diagnosed) such as Stroke and Myocardial revascularization (specifically coronary artery bypass grafting, percutaneous coronary interventions, carotid endarterectomy) were recorded'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['atherosclerotic plaque', 'MRI', 'inflammatory markers', 'statins'], 'conditions': ['Atherosclerosis', 'Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '9761083', 'type': 'BACKGROUND', 'citation': "Guyton JR, Goldberg AC, Kreisberg RA, Sprecher DL, Superko HR, O'Connor CM. Effectiveness of once-nightly dosing of extended-release niacin alone and in combination for hypercholesterolemia. Am J Cardiol. 1998 Sep 15;82(6):737-43. doi: 10.1016/s0002-9149(98)00448-2."}, {'pmid': '9989957', 'type': 'BACKGROUND', 'citation': 'Ballantyne CM, Herd JA, Ferlic LL, Dunn JK, Farmer JA, Jones PH, Schein JR, Gotto AM Jr. Influence of low HDL on progression of coronary artery disease and response to fluvastatin therapy. Circulation. 1999 Feb 16;99(6):736-43. doi: 10.1161/01.cir.99.6.736.'}, {'pmid': '11757504', 'type': 'BACKGROUND', 'citation': 'Brown BG, Zhao XQ, Chait A, Fisher LD, Cheung MC, Morse JS, Dowdy AA, Marino EK, Bolson EL, Alaupovic P, Frohlich J, Albers JJ. Simvastatin and niacin, antioxidant vitamins, or the combination for the prevention of coronary disease. N Engl J Med. 2001 Nov 29;345(22):1583-92. doi: 10.1056/NEJMoa011090.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the added benefits of increased high-density lipoprotein (HDL) cholesterol serum levels over and above those achieved by lipid lowering therapy guided by current guidelines, in older individuals with cardiovascular disease.', 'detailedDescription': 'The hypothesis being tested is that the current standard lipid lowering therapy, combined with a 20 percent or greater increase in serum HDL induced by long-acting niacin, reduces plaque size in older individuals with cardiovascular disease. The specific aims of testing this hypothesis are:\n\n1. to determine the effects of statin plus placebo vs. statin plus niacin therapy on plaque size and composition,\n2. to determine whether alterations of inflammatory markers of atherosclerosis induced by lipid lowering therapy parallel alterations of plaque architecture and composition in older patients with cardiovascular disease,\n3. to determine the effects of these interventions on the incidence of cardiovascular and cerebrovascular events.\n\nThe results of the trial will be directly applicable to developing strategies for plaque stabilization in the elderly who suffer the most from the severe complications of advanced cardiovascular atherosclerosis.\n\nA total of 144 participants aged 65 and older with cardiovascular or cerebrovascular disease will be recruited. Participants will be randomized to receive either statin plus niacin or statin plus a placebo for 18 months. Participants will be provided a prescription for fluvastatin 80 mg to be taken on a daily basis, or they may continue their ongoing or any other cholesterol-lowering drugs such as pravastatin 80 mg daily, simvastatin 20 mg daily, atorvastatin up to 20 mg daily or rosuvastatin up to 20 mg daily. Ten visits are expected, initially every 4 weeks for dose adjustment. Then visits will be every 6 months; MRI, Inflammatory Markers tests, and other lab tests will be done at baseline and the visits at months 6, 12, and 18.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 65 or older\n* Documented clinical cardiovascular or cerebrovascular disease due to atherosclerosis\n* Candidate for lipid lowering therapy; no contraindication to fluvastatin, niacin or aspirin therapy\n* Low-density lipoprotein (LDL) cholesterol below 150 mg/dl if untreated or below 125 mg/dl on statin monotherapy\n* Willing to discontinue present therapy if private physician agrees with enrollment\n* Eligible to undergo trans-esophageal magnetic resonance imaging (MRI); no contraindications to Gadolinium-DTPA, the contrast agent used\n* Willing to sign Informed Consent\n\nExclusion Criteria:\n\n* Ineligibility for MRI procedure due to pacemaker, metal implants, or other ferromagnetic devices\n* Claustrophobia\n* Previously documented esophageal disease which would preclude trans-esophageal MRI\n* LDL-C greater than 150 mg/dl off lipid lowering therapy or daily statin therapy requiring doses greater than 20 mg of atorvastatin, 20 mg of simvastatin, 80 mg of lovastatin, 80 mg of pravastatin, 80 mg of extended release fluvastatin, or 20 mg of rosuvastatin\n* Contraindication or allergy to statins or aspirin\n* Current use of or known intolerance or allergy to Niaspan (a long-acting niacin)\n* Allergy or intolerance to Gadolinium-DTPA (MRI contrast agent)\n* Liver or kidney failure defined clinically and by laboratory data\n* Mental, neurologic or social condition preventing understanding of the rationale, procedures, risks and potential benefits associated with the trial'}, 'identificationModule': {'nctId': 'NCT00127218', 'acronym': 'NIA-Plaque', 'briefTitle': 'High-Density Lipoprotein (HDL) Cholesterol Increased Plaque Stabilization in the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'HDL Increased Plaque Stabilization in the Elderly', 'orgStudyIdInfo': {'id': 'NA_00035188'}, 'secondaryIdInfos': [{'id': '5R01AG021570-03', 'link': 'https://reporter.nih.gov/quickSearch/5R01AG021570-03', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'any statin plus niacin', 'interventionNames': ['Drug: any statin', 'Drug: niacin']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'any statin plus placebo', 'interventionNames': ['Drug: any statin', 'Drug: Placebo']}], 'interventions': [{'name': 'any statin', 'type': 'DRUG', 'otherNames': ['fluvastatin (Lescol)', 'pravastatin (Pravachol)', 'simvastatin (Vytorin)', 'atorvastatin (Lipitor)', 'rosuvastatin (Crestor)'], 'description': 'Participants will be provided a prescription for fluvastatin 80 mg to be taken on a daily basis, or they may continue their ongoing or any other cholesterol-lowering drugs such as pravastatin 80 mg daily, simvastatin 20 mg daily, atorvastatin up to 20 mg daily or rosuvastatin up to 20 mg daily for 18 months', 'armGroupLabels': ['1', '2']}, {'name': 'niacin', 'type': 'DRUG', 'description': 'long-acting niacin daily for 18 months', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'matching placebo pill daily for 18 months', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21218', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Unversity School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Joao AC Lima, MD, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}