Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-06 @ 1:21 PM
Study NCT ID:
NCT03533959
Status:
RECRUITING
Last Update Posted:
2018-05-30
First Post:
2018-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Efficacy of Alirocumab for Neoatherosclerosis by Using OCT, in Comparison With Standard Statin Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C571059', 'term': 'alirocumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 31}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-28', 'studyFirstSubmitDate': '2018-05-11', 'studyFirstSubmitQcDate': '2018-05-22', 'lastUpdatePostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lipid index change between baseline and 9 month follow-up', 'timeFrame': 'Baseline and 9 month follow-up', 'description': 'Lipid core arc was measured by every 0.2-mm interval throughout segments with neoatherosclerosis (NA) on optical coherence tomography (OCT) findings. The mean lipid core arc was calculated for each lesion. Then, the lipid index was calculated by multiplying the mean lipid core arc by the lipid core longitudinal length.'}], 'secondaryOutcomes': [{'measure': 'Macrophage grade change between baseline and 9 month follow-up', 'timeFrame': 'Baseline and 9 month follow-up', 'description': 'Macrophage arc were measured on OCT images with NA every 0.2-mm intervals and divided 4 groups as follows: grade 0, no mac¬rophage; grade 1, localized macrophage accumulation (\\<30°); grade 2, clus¬tered accumulation ≥30° and \\<90°; grade 3, clus¬tered accumulation ≥90° and \\<270°; and grade 4, clustered accumulation ≥270° and \\<360° . Macrophage grade was evaluated as summation of 0 to 4 grades across all cross section in NA.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['in-stent neoatherosclerosis', 'alirocumab'], 'conditions': ['Coronary Artery Disease Progression']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the efficacy of alirocumab for in-stent neoatherosclerosis by using optical coherence tomography, in comparison with standard statin therapy.', 'detailedDescription': 'The investigators investigate to evaluate the efficacy of alirocumab for in-stent neoatherosclerosis. The investigators enrolled the patient who performed drug eluting stent implantation and detected in-stent neoatherosclerosis by follow up optical coherence tomography, and categorized into two group; the patients with alirocumab and rosuvastatin the investigatorsre categorized alirocumab therapy group, and the patients with rosuvastatin alone were categorized standard statin therapy group.\n\nThe investigators compare these two group for outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with stent implantation who were performed coronary angiography and optical coherence tomography (OCT) follow-up of the coronary arteries were candidate.\n\nThese patients were implanted drug elutingstent including sirolimus-eluting stents (Cypher, Cordis, Miami Lakes, FL, USA), paclitaxel-eluting stents (Taxus, Boston Scientific, Natick, MA, USA), or everolimus-eluting stents (XIENCE V, Abbott Vascular, Santa Clara, CA, USA). The investigators assessed their OCT examination at the follow-up OCT time and patients who were detected NA on OCT findings were eligible for the presence study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The age at the time of consent acquisition is 20 years old or over.\n2. OCT Images that can be analyzed are obtained, and neoatherosclerosis existed in drug eluting stent\n3. lipid lowering therapy with rosuvastatin 10 mg or rosuvastatin 10 mg and aliclumab is performed.\n4. Baseline OCT was scheduled to be revisited within 6 to 12 months, or already performed.\n5. Document consent has been obtained from the subject person to this research.\n\nExclusion Criteria:\n\n1. Patients who have received treatment with PCSK 9 inhibitor in the past\n2. Patients whose treatment was interrupted before follow-up catheterization during the observation period\n3. Patients underwent LDL apheresis.\n4. In the case that the researchers judges it as inappropriate as the object of this research.'}, 'identificationModule': {'nctId': 'NCT03533959', 'acronym': 'POLARIS', 'briefTitle': 'To Evaluate the Efficacy of Alirocumab for Neoatherosclerosis by Using OCT, in Comparison With Standard Statin Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kobe University'}, 'officialTitle': 'Prospective Observational Study for Lesion of Neoatherosclerosis: The Efficacy of Alirocumab for the Neoatherosclerosis Reaction Investigated by Serial Optical Coherence Tomography', 'orgStudyIdInfo': {'id': 'KobeU-170179'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'alirocumab therapy group', 'description': 'patients with 10mg daily rosuvastatin and alirocumab at least 75mg every 2 weaks', 'interventionNames': ['Drug: Alirocumab']}, {'label': 'standard statin therapy group', 'description': 'patient with 10mg daily rosuvastatin and never use alirocumab or other PCSK-9 inhibitor'}], 'interventions': [{'name': 'Alirocumab', 'type': 'DRUG', 'description': 'the administration of Alirocumab at least 75mg every 2 weeks', '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': '+81-78-382-5111'}, {'name': 'Yoichiro Sugizaki, M.D.', 'role': 'CONTACT', 'email': 'you0724@med.kobe-u.ac.jp', 'phone': '+81-78-382-5111'}], 'overallOfficials': [{'name': 'Hiromasa Otake, M.D., Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Kobe University Graduate School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kobe University', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hiromasa Otake', 'investigatorAffiliation': 'Kobe University'}}}}