Ignite Creation Date:
2025-12-25 @ 3:17 AM
Ignite Modification Date:
2026-03-02 @ 4:22 PM
Study NCT ID:
NCT05397405
Status:
RECRUITING
Last Update Posted:
2024-11-15
First Post:
2022-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Blood Lipid Management in Symptomatic Intracranial Atherosclerotic Stenosis on Clinical Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-13', 'studyFirstSubmitDate': '2022-05-23', 'studyFirstSubmitQcDate': '2022-05-26', 'lastUpdatePostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrent stroke', 'timeFrame': '6 months-12 months', 'description': 'the recurrent rate of clinical stroke'}], 'secondaryOutcomes': [{'measure': 'Intracranial arterial', 'timeFrame': '6 months or 12 months', 'description': 'Degree of change in intracranial arterial stenosis'}, {'measure': 'Plaque changes', 'timeFrame': '6 months or 12 months', 'description': 'Plaque volume and load changes'}, {'measure': 'Vascular remodeling index', 'timeFrame': '6 months or 12 months', 'description': 'Vascular remodeling index changes'}, {'measure': 'Adverse events', 'timeFrame': '6 months or 12 months', 'description': 'The incidence of muscle related events, allergic reactions, injection site reactions, bleeding events and other adverse events was assessed'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['symptomatic intracranial atherosclerotic stenosis', 'stroke', 'blood lipid management', 'PCSK9 inhibitors'], 'conditions': ['Intracranial Artery Stenosis']}, 'descriptionModule': {'briefSummary': 'sICASBLM is a prospective controlled trial, to asses the impact of improving blood lipid management on clinical outcome of moderate to severe symptomatic intracranial atherosclerotic stenosis patients (LDL-C\\>1.8mmol/L) without endovascular therapy.', 'detailedDescription': 'sICASBLM aims to determine the effectiveness of conventional lipid management combined with PCSK9 inhibitors compared to conventional lipid management (atorvastatin 20-40mg or rosuvastatin 10-20mg or simvastatin 20-40mg) in reducing the incidence of recurrent stroke in patients with moderate to severe symptomatic intracranial atherosclerotic stenosis (LDL-C\\>1.8mmol/L) without endovascular therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years\n2. Symptomatic intracranial atherosclerotic stenosis of moderate to severe, did not receive intravenous thrombolysis, thrombectomy, stent implantation and other intravascular treatment\n3. low density lipoprotein cholesterol \\> 70mg/dl (1.8mmol/L)\n4. Receive 3T magnetic resonance angiography or multi-mode MR (high resolution is required), angiography can be included, and images for analysis can be obtained.\n5. Lipid-lowering indications of statins\n6. Signed an approved informed consents\n\nExclusion Criteria:\n\n1. Contraindications to statins\n2. There are contraindications to MRI examination or cannot accept MRI examination\n3. Stenosis caused by vasculitis, arterial dissection and moyamoya disease\n4. Patients with active bleeding or obvious bleeding tendency\n5. Severe heart, lung, renal insufficiency, malignant tumor or other malignant diseases, and death is highly likely within 7 days; pregnancy or women who are lactating\n6. Uncontrolled severe diabetes and hypertension\n7. Other conditions inappropriate for inclusion judged by investigators'}, 'identificationModule': {'nctId': 'NCT05397405', 'acronym': 'sICASBLM', 'briefTitle': 'Improving Blood Lipid Management in Symptomatic Intracranial Atherosclerotic Stenosis on Clinical Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing First Hospital, Nanjing Medical University'}, 'officialTitle': 'A Prospective Observational Study on the Effect of Improving Blood Lipid Management on the Clinical Prognosis of Symptomatic Intracranial Atherosclerotic Stenosis（sICASBLM）', 'orgStudyIdInfo': {'id': 'sICASBLM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Blood Lipid management with atorvastatin 20-40mg or rosuvastatin 10-20mg or simvastatin 20-40mg and PCSK9 inhibitors for 6-12 months', 'interventionNames': ['Drug: PCSK9 inhibitor']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Blood Lipid management with atorvastatin 20-40mg or rosuvastatin 10-20mg or simvastatin 20-40mg for 6-12 months'}], 'interventions': [{'name': 'PCSK9 inhibitor', 'type': 'DRUG', 'otherNames': ['intensive blood lipid lowing'], 'description': 'The aim is to improve blood lipid management by using atorvastatin 20-40mg or rosuvastatin 10-20mg or simvastatin 20-40mg and PCSK9 inhibitors for 6-12 months', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210006', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junshan Zhou, M.D.', 'role': 'CONTACT', 'email': 'zhjsh333@126.com', 'phone': '+86025-87726218'}, {'name': 'Qiwen Deng, M.D.', 'role': 'CONTACT', 'email': 'qiw_deng@163.com', 'phone': '+86025-87726218'}], 'facility': 'Nanjing First Hospital, Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '210006', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Nanjing First Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Junshan Zhou', 'role': 'CONTACT', 'email': 'zhjsh333@126.com', 'phone': '8602587726218'}, {'name': 'Qiwen Deng', 'role': 'CONTACT', 'email': 'qiw_deng@163.com', 'phone': '8602587726218'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing First Hospital, Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}