Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-25 @ 9:41 PM
Study NCT ID:
NCT05585151
Status:
RECRUITING
Last Update Posted:
2023-12-11
First Post:
2022-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High-Resolution Assessment of Extracranial Plaques in a Multiple Centers Evolocumab Randomized Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002537', 'term': 'Intracranial Arteriosclerosis'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C577155', 'term': 'evolocumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-04', 'studyFirstSubmitDate': '2022-10-12', 'studyFirstSubmitQcDate': '2022-10-15', 'lastUpdatePostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Occurrence of ischemic vascular events', 'timeFrame': '27 Weeks ± 7 days', 'description': 'Occurrence of ischemic vascular events, such as TIA, acute cerebral infarction, acute myocardial infarction, etc.'}, {'measure': 'Adverse events/serious adverse events', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'Adverse events/serious adverse events'}], 'primaryOutcomes': [{'measure': 'Changes of the thickness of fibrous cap of artery plaque measured by OCT', 'timeFrame': '27 Weeks ± 7 days', 'description': 'Changes of the thickness of fibrous cap of artery plaque measured by OCT'}], 'secondaryOutcomes': [{'measure': 'Changes of the lipid arc of artery plaque measured by OCT', 'timeFrame': '27 Weeks ± 7 days', 'description': 'Changes of the lipid arc of artery plaque measured by OCT'}, {'measure': 'Changes of the minimum lumen area (MLA) measured by OCT', 'timeFrame': '27 Weeks ± 7 days', 'description': 'Changes of the minimum lumen area (MLA) measured by OCT'}, {'measure': 'Changes of lumen area stenosis measured by OCT', 'timeFrame': '27 Weeks ± 7 days', 'description': 'Changes of lumen area stenosis measured by OCT'}, {'measure': 'Changes of the number of microvessels measured by OCT', 'timeFrame': '27 Weeks ± 7 days', 'description': 'Changes of the number of microvessels measured by OCT'}, {'measure': 'Changes of the presence and extension of macrophages measured by OCT', 'timeFrame': '27 Weeks ± 7 days', 'description': 'Changes of the presence and extension of macrophages measured by OCT'}, {'measure': 'Changes of the calcium aggregation measured by OCT', 'timeFrame': '27 Weeks ± 7 days', 'description': 'Changes of the calcium aggregation measured by OCT'}, {'measure': 'Changes of arterial plaque volume measured by OCT', 'timeFrame': '27 Weeks ± 7 days', 'description': 'Changes of arterial plaque volume measured by OCT'}, {'measure': 'Changes of lipid necrotic core of arterial plaque measured by OCT', 'timeFrame': '27 Weeks ± 7 days', 'description': 'Changes of lipid necrotic core of arterial plaque measured by OCT'}, {'measure': 'Changes of LDL-C levels', 'timeFrame': '27 Weeks ± 7 days', 'description': 'Changes of LDL-C levels'}, {'measure': 'Changes of the thickness of minimum fibrous cap of artery plaque measured by 3D-ultrasound', 'timeFrame': '27 Weeks ± 7 days', 'description': 'Changes of the thickness of minimum fibrous cap of artery plaque measured by 3D-ultrasound'}, {'measure': 'Changes of arterial plaque volume measured by 3D-ultrasound', 'timeFrame': '27 Weeks ± 7 days', 'description': 'Changes of arterial plaque volume measured by 3D-ultrasound'}, {'measure': 'Changes of Lipid necrotic core of arterial plaque measured by 3D-ultrasound', 'timeFrame': '27 Weeks ± 7 days', 'description': 'Changes of Lipid necrotic core of arterial plaque measured by 3D-ultrasound'}, {'measure': 'Changes of the thickness of minimum fibrous cap of artery plaque measured by High resolution magnetic resonance', 'timeFrame': '27 Weeks ± 7 days', 'description': 'Changes of the thickness of minimum fibrous cap of artery plaque measured by High resolution magnetic resonance'}, {'measure': 'Changes of arterial plaque volume measured by High resolution magnetic resonance', 'timeFrame': '27 Weeks ± 7 days', 'description': 'Changes of arterial plaque volume measured by High resolution magnetic resonance'}, {'measure': 'Changes of Lipid necrotic core of arterial plaque measured by High resolution magnetic resonance', 'timeFrame': '27 Weeks ± 7 days', 'description': 'Changes of Lipid necrotic core of arterial plaque measured by High resolution magnetic resonance'}, {'measure': 'Correlation between arterial plaque and new risk factors for cardiovascular and cerebrovascular diseases (serum hsCRP, other markers, etc.)', 'timeFrame': '27 Weeks ± 7 days', 'description': 'Correlation between arterial plaque and new risk factors for cardiovascular and cerebrovascular diseases (serum hsCRP, other markers, etc.)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['atherosclerosis', 'plaque burden', 'Evolocumab', 'High-Resolution assessment', 'OCT'], 'conditions': ['Cerebral Atherosclerosis']}, 'descriptionModule': {'briefSummary': 'This study intends to explore the therapeutic effect of PCSK9i Evolocumab on atherosclerotic plaques in cerebral arteries (including carotid and vertebral arteries) compared with intensive statin treatment, and monitor the pathological properties of carotid/vertebral artery plaques with OCT technology. At the same time, three-dimensional ultrasound and high-resolution magnetic resonance are used to explore the new mechanism of pathological changes of cerebral atherosclerotic plaques in a multidimensional manner.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years old, regardless of sex;\n2. Cerebrovascular angiography examination was performed, and the imaging characteristics were consistent with: 1) The stenosis degree of internal carotid artery (starting from C1 segment) or vertebral artery (starting from vertebral artery to V4 segment) was 20%-69%; 2) The target vessel for imaging has not undergone or intends to undergo revascularization and must be available for OCT imaging catheter;\n3. Participants who understand and sign the informed consent form voluntarily.\n\nExclusion Criteria:\n\n1. Intolerant to both atorvastatin and rosuvastatin;\n2. History of major surgery or endovascular treatment within 3 months prior to the screening period;\n3. Arterial stenosis or occlusion not caused by atherosclerosis, such as arterial dissection, moya-moya disease, vasculitis, radiation vascular disease, or fibromuscular dysplasia;\n4. Abnormal liver function (ALT \\> 3 times the upper limit of normal);\n5. Renal dysfunction (glomerular filtration rate (eGFR) \\<45 mL/min/1.73m2 at screening);\n6. Thrombocytopenia (PLT\\<100G/L);\n7. The expected survival time is not more than 6 months;\n8. Other known serious life-threatening disease (such as hematologic disease, malignancy), unstable vital signs or need for continuous monitoring, or moribund state during screening;\n9. Patients have been included in other studies that conflict with this study;\n10. Known sensitivity to any of the products or components to be administered during dosing;\n11. Pregnant, breastfeeding or planning pregnancy, and other conditions that the investigator considers the patient unsuitable for enrollment;\n12. Other conditions that the investigator considered inappropriate for enrollment.'}, 'identificationModule': {'nctId': 'NCT05585151', 'briefTitle': 'High-Resolution Assessment of Extracranial Plaques in a Multiple Centers Evolocumab Randomized Study', 'organization': {'class': 'OTHER', 'fullName': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, 'officialTitle': 'High-Resolution Assessment of Extracranial Plaques in a Multiple Centers Evolocumab Randomized Study', 'orgStudyIdInfo': {'id': 'HERALD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Evolocumab treatment group', 'description': 'Evolocumab treatment, 1ml：140mg, every 2 weeks, for 26 weeks', 'interventionNames': ['Drug: Evolocumab 140 MG/ML']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intensive statin treatment group', 'description': 'Atorvastatin 40mg/day or rosuvastatin 20mg/day, for 26 weeks', 'interventionNames': ['Drug: Intensive statin treatment']}], 'interventions': [{'name': 'Evolocumab 140 MG/ML', 'type': 'DRUG', 'description': 'Evolocumab 140mg, subcutaneous injection, every 2 weeks, for 26 week, total 13 times', 'armGroupLabels': ['Evolocumab treatment group']}, {'name': 'Intensive statin treatment', 'type': 'DRUG', 'description': 'Intensive statin could choose either Atorvastatin 40mg/day or Rosuvastatin 20mg/day, for 26 weeks', 'armGroupLabels': ['Intensive statin treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Wan, PHD', 'role': 'CONTACT', 'email': 'wanyanalan@163.com', 'phone': '+8615872394527'}, {'name': 'Shengcai Chen, PHD', 'role': 'CONTACT'}], 'facility': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Yan Wan, Doctor', 'role': 'CONTACT', 'email': 'wanyanalan@163.com', 'phone': '+8615872394527'}, {'name': 'Shengcai Chen, Doctor', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Bo Hu, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Union Hospital, Tongji Medical College, Huahzong University of Science and Technology'}, {'name': 'Candong Hong, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Union Hospital, Tongji Medical College, Huahzong University of Science and Technology'}, {'name': 'Lei Zhang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Union Hospital, Tongji Medical College, Huahzong University of Science and Technology'}, {'name': 'Quanwei He, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Union Hospital, Tongji Medical College, Huahzong University of Science and Technology'}, {'name': 'Jiehong Wu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Union Hospital, Tongji Medical College, Huahzong University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'head of Neurology Department', 'investigatorFullName': 'Hu Bo', 'investigatorAffiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}}}}