Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2025-12-25 @ 7:23 PM
Study NCT ID:
NCT03552432
Status:
UNKNOWN
Last Update Posted:
2018-11-14
First Post:
2018-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficacy of Alirocumab for Thin-cap fIbroatheroma in Patients With Coronary Artery Disease Estimated by Optical Coherence Tomography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571059', 'term': 'alirocumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-11', 'studyFirstSubmitDate': '2018-05-07', 'studyFirstSubmitQcDate': '2018-06-08', 'lastUpdatePostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the change in fibrous cap thickness', 'timeFrame': '9 month', 'description': 'the absolute change in minimum fibrous-cap thickness between baseline and 36-week follow-up'}], 'secondaryOutcomes': [{'measure': 'the change in fibrous cap thickness', 'timeFrame': '9 month', 'description': 'the percent change in minimum fibrous-cap thickness between baseline and 36-week follow-up'}, {'measure': 'the change in lipid index', 'timeFrame': '9 month', 'description': 'absolute change in lipid index between baseline and 36-week follow-up'}, {'measure': 'the change in lipid index', 'timeFrame': '9 month', 'description': 'percentage change in lipid index between baseline and 36-week follow-up'}, {'measure': 'the change in lipid length,', 'timeFrame': '9 month', 'description': 'absolute change in lipid core length between baseline and 36-week follow-up'}, {'measure': 'the change in lipid length,', 'timeFrame': '9 month', 'description': 'percentage change in lipid core length between baseline and 36-week follow-up'}, {'measure': 'the change in mean lipid arc', 'timeFrame': '9 month', 'description': 'absolute change in mean lipid arc between baseline and 36-week follow-up'}, {'measure': 'the change in mean lipid arc', 'timeFrame': '9 month', 'description': 'percentage change in mean lipid arc between baseline and 36-week follow-up'}, {'measure': 'the change in max lipid arc', 'timeFrame': '9 month', 'description': 'absolute change in max lipid arc between baseline and 36-week follow-up'}, {'measure': 'the change in max lipid arc', 'timeFrame': '9 month', 'description': 'percent change in max lipid arc between baseline and 36-week follow-up'}, {'measure': 'the change in macrophage grade', 'timeFrame': '9 month', 'description': 'absolute change in summation of macrophage grade between baseline and 36-week follow-up.\n\nmacrophage grade defined as an OCT macrophage grading system to semiquantify the bright spots based on axial and circumferential distribution, as follows: grade 0, no macrophage; grade 1, localized macrophage accumulation; grade 2, clustered accumulation \\<1 quadrant; grade 3, clustered accumulation \\>1 quadrant and ≦3 quadrants; and grade 4, clustered accumulation ≧3'}, {'measure': 'the change in macrophage grade', 'timeFrame': '9 month', 'description': 'percentage change in summation of macrophage grade between baseline and 36-week follow-up.\n\nmacrophage grade defined as an OCT macrophage grading system to semiquantify the bright spots based on axial and circumferential distribution, as follows: grade 0, no macrophage; grade 1, localized macrophage accumulation; grade 2, clustered accumulation \\<1 quadrant; grade 3, clustered accumulation \\>1 quadrant and ≦3 quadrants; and grade 4, clustered accumulation ≧3'}, {'measure': 'the change in minimum lumen area', 'timeFrame': '9 month', 'description': 'absolute change in minimum lumen area between baseline and 36-week follow-up'}, {'measure': 'the change in minimum lumen area', 'timeFrame': '9 month', 'description': 'percentage of change in minimum lumen area between baseline and 36-week follow-up'}, {'measure': 'the number of thin-cap fibroatheroma', 'timeFrame': '9 month', 'description': 'change of the number of thin-cap fibroatheroma at 36-week follow-up'}, {'measure': 'the change in total cholesterol', 'timeFrame': '9 month', 'description': 'absolute change in serum level of of total cholesterol between baseline and 36-week follow-up'}, {'measure': 'the change in total cholesterol', 'timeFrame': '9 month', 'description': 'percent change in serum level of of total cholesterol between baseline and 36-week follow-up'}, {'measure': 'the change in LDL-C', 'timeFrame': '9 month', 'description': 'absolute change in serum level of of LDL-C between baseline and 36-week follow-up'}, {'measure': 'the change in LDL-C', 'timeFrame': '9 month', 'description': 'percentage change in serum level of of LDL-C between baseline and 36-week follow-up'}, {'measure': 'the change in HDL-C', 'timeFrame': '9 month', 'description': 'absolute change in serum level of of HDL-C between baseline and 36-week follow-up'}, {'measure': 'the change in HDL-C', 'timeFrame': '9 month', 'description': 'percentage change in serum level of of HDL-C between baseline and 36-week follow-up'}, {'measure': 'the change in non-HDL-C', 'timeFrame': '9 month', 'description': 'absolute change in serum level of of non-HDL-C between baseline and 36-week follow-up'}, {'measure': 'the change in non-HDL-C', 'timeFrame': '9 month', 'description': 'percentage change in serum level of of non-HDL-C between baseline and 36-week follow-up'}, {'measure': 'the change in apolipoprotein B', 'timeFrame': '9 month', 'description': 'absolute change in serum level of of apolipoprotein B between baseline and 36-week follow-up'}, {'measure': 'the change in apolipoprotein B', 'timeFrame': '9 month', 'description': 'percentage change in serum level of of apolipoprotein B between baseline and 36-week follow-up'}, {'measure': 'the change in Lp(a)', 'timeFrame': '9 month', 'description': 'absolute change in serum level of of Lp (a) between baseline and 36-week follow-up'}, {'measure': 'the change in Lp(a)', 'timeFrame': '9 month', 'description': 'percentage change in serum level of of Lp (a) between baseline and 36-week follow-up'}, {'measure': 'the change in hs-CRP', 'timeFrame': '9 month', 'description': 'absolute change in serum level of hs-CRP between baseline and 36-week follow-up'}, {'measure': 'the change in hs-CRP', 'timeFrame': '9 month', 'description': 'percentage change in serum level of hs-CRP between baseline and 36-week follow-up'}, {'measure': 'the change in IL-1β', 'timeFrame': '9 month', 'description': 'absolute change in serum level of IL-1β between baseline and 36-week follow-up'}, {'measure': 'the change in IL-1β', 'timeFrame': '9 month', 'description': 'percentage change in serum level of IL-1β between baseline and 36-week follow-up'}, {'measure': 'the change in IL-6', 'timeFrame': '9 month', 'description': 'absolute change in serum level of IL-6 between baseline and 36-week follow-up'}, {'measure': 'the change in IL-6', 'timeFrame': '9 month', 'description': 'percentage change in serum level of IL-6 between baseline and 36-week follow-up'}, {'measure': 'the change in TNF-α', 'timeFrame': '9 month', 'description': 'absolute change in serum level of TNF-α between baseline and 36-week follow-up'}, {'measure': 'the change in TNF-α', 'timeFrame': '9 month', 'description': 'percentage change in serum level of TNF-α between baseline and 36-week follow-up'}, {'measure': 'the change in MCP-1', 'timeFrame': '9 month', 'description': 'absolute change in serum level of MCP-1 between baseline and 36-week follow-up'}, {'measure': 'the change in MCP-1', 'timeFrame': '9 month', 'description': 'percentage change in serum level of MCP-1 between baseline and 36-week follow-up'}, {'measure': 'the change in MMP-2', 'timeFrame': '9 month', 'description': 'absolute change in serum level ofMMP-2 between baseline and 36-week follow-up'}, {'measure': 'the change in MMP-2', 'timeFrame': '9 month', 'description': 'percentage change in serum level ofMMP-2 between baseline and 36-week follow-up'}, {'measure': 'the change in MMP-9', 'timeFrame': '9 month', 'description': 'absolute change in serum level of MMP-9 between baseline and 36-week follow-up'}, {'measure': 'the change in MMP-9', 'timeFrame': '9 month', 'description': 'percentage change in serum level of MMP-9 between baseline and 36-week follow-up'}, {'measure': 'the change in VCAM-1', 'timeFrame': '9 month', 'description': 'absolute change in serum level of VCAM-1between baseline and 36-week follow-up'}, {'measure': 'the change in VCAM-1', 'timeFrame': '9 month', 'description': 'percentage change in serum level of VCAM-1 between baseline and 36-week follow-up'}, {'measure': 'the change in ICAM-1', 'timeFrame': '9 month', 'description': 'absolute change in serum level of ICAM-1 between baseline and 36-week follow-up'}, {'measure': 'the change in ICAM-1', 'timeFrame': '9 month', 'description': 'percentage change in serum level of ICAM-1 between baseline and 36-week follow-up'}, {'measure': 'the change in free PCSK9', 'timeFrame': '9 month', 'description': 'absolute change in serum level of free PCSK9 between baseline and 36-week follow-up'}, {'measure': 'the change in free PCSK9', 'timeFrame': '9 month', 'description': 'percentage change in serum level of free PCSK9 between baseline and 36-week follow-up'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['alirocumab', 'Thin-cap fIbroatheroma (TCFA)', 'vulnerable plaque', 'Optical Coherence Tomography (OCT)'], 'conditions': ['Coronary Artery Disease', 'Thin-cap fIbroatheroma']}, 'referencesModule': {'references': [{'pmid': '30579806', 'type': 'DERIVED', 'citation': 'Otake H, Sugizaki Y, Toba T, Nagano Y, Tsukiyama Y, Yanaka KI, Yamamoto H, Nagasawa A, Onishi H, Takeshige R, Nakano S, Matsuoka Y, Tanimura K, Kawamori H, Shinke T, Hirata KI. Efficacy of alirocumab for reducing plaque vulnerability: Study protocol for ALTAIR, a randomized controlled trial in Japanese patients with coronary artery disease receiving rosuvastatin. J Cardiol. 2019 Mar;73(3):228-232. doi: 10.1016/j.jjcc.2018.11.012. Epub 2018 Dec 19.'}]}, 'descriptionModule': {'briefSummary': 'the purpose of this study is to show that alirocumab with statin therapy have a s tronger stabilizing effect on vulnerable plaque in coronary artery disease than statin alone administration', 'detailedDescription': 'The investigators investigate to evaluate the efficacy of alirocumab for vulnerable plaque. The investigators enrolled the patient with standard statin therapy who were detected vulnerable plaque by optical coherence tomography, and categorized into two group; the patients with alirocumab and rosuvastatin were categorized alirocumab therapy group, and the patients with rosuvastatin alone were categorized standard statin therapy group. The investigators compare these two group for outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who underwent PCI for ACS or stable coronary heart disease\n2. Patients with LDL-C ≥70 mg/dL under daily 10mg rosuvastatin\n3. Patients who have been had TCFA detected by OCT\n4. Patients aged ≥20 years old at PCI\n5. Patients who agree to be enrolled in the trial giving signed written informed consent\n\nExclusion Criteria:\n\n1. Patients who have been treated previously with at least one dose of any anti-PCSK9 monoclonal antibody\n2. Patients had uncontrolled hypertension (systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>110 mmHg) between the time of PCI and randomization visit\n3. Known hypersensitivity to alirocumab or rosuvastatin\n4. All contraindications to alirocumab and/or rosuvastatin as displayed in the respective national product labeling for these treatments\n5. Known history of hemorrhagic stroke\n6. Currently under treatment for cancer\n7. Patients on lipoprotein apheresis\n8. Patients with severe liver or renal dysfunction\n9. Pregnant or breast-feeding women\n10. Considered by the investigator as inappropriate for this study for any reason'}, 'identificationModule': {'nctId': 'NCT03552432', 'acronym': 'ALTAIR', 'briefTitle': 'The Efficacy of Alirocumab for Thin-cap fIbroatheroma in Patients With Coronary Artery Disease Estimated by Optical Coherence Tomography', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kobe University'}, 'officialTitle': 'The Efficacy of Alirocumab for Thin-cap fIbroatheroma in Patients With Coronary Artery Disease Estimated by Optical Coherence Tomography: Single Center, Randomized, Open-label, Trial', 'orgStudyIdInfo': {'id': 'KobeU-290017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alirocumab therapy group', 'description': 'start with alirocumab 75mg per 2weeks and rosuvastatin 10mg per day', 'interventionNames': ['Drug: Alirocumab']}, {'type': 'NO_INTERVENTION', 'label': 'standard statin therapy group', 'description': 'start with only rosuvastatin 10mg per day'}], 'interventions': [{'name': 'Alirocumab', 'type': 'DRUG', 'description': 'the administration of Alirocumab by Subcutaneous injection 75mg every 2 weeks plus Rosuvastatin10mg/daily by oral for 9 months', 'armGroupLabels': ['Alirocumab therapy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '650-0017', 'city': 'Kobe', 'state': 'Hyōgo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Hiromasa Otake, MD', 'role': 'CONTACT', 'email': 'hotake@med.kobe-u.ac.jp', 'phone': '+81783825846'}], 'facility': 'Kobe University Graduate School of Medicine, Department of Cardiology', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}], 'centralContacts': [{'name': 'Hiromasa Otake, M.D, Ph,D', 'role': 'CONTACT', 'email': 'hotake@med.kobe-u.ac.jp', 'phone': '+81-78-382-5846'}], 'overallOfficials': [{'name': 'Hiromasa Otake, M.D, Ph,D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kobe University Graduate School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kobe University', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Lecturer', 'investigatorFullName': 'Hiromasa Otake', 'investigatorAffiliation': 'Kobe University'}}}}