[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602162":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":42,"responsibleParty":60,"collaborators":11,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":11,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":84,"whyStopped":11,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Recaticimab group","EXPERIMENTAL",null,[13],"Drug: Recaticimab",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo group","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Recaticimab","Recaticimab 300mg subcutaneous Q8W for 1 year.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Placebo","Matched placebo subcutaneous Q8W for 1 year.",[15],[30],{"name":31,"affiliation":5,"role":32},"Yamei Tang","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},"Yaxuan Pi","CONTACT","86-20-81332619","piyx@mail2.sysu.edu.cn",{"name":40,"role":36,"phone":11,"phoneExt":11,"email":41},"Xinguang Yang","yangxinguang0926@163.com",[43],{"facility":44,"status":11,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University","Guangzhou","Guangdong","510120","China","CN",{"type":51,"coordinates":52},"Point",[53,54],113.25,23.11667,{"lat":54,"lon":53},[57,58,59],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},{"name":40,"role":36,"phone":11,"phoneExt":11,"email":41},{"name":31,"role":32,"phone":11,"phoneExt":11,"email":11},{"type":32,"investigatorFullName":31,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Vice President of Sun Yat-sen Memorial Hospital","100602162","phase-3-pcsk9-inhibitor-for-intracranial-atherosclerotic-symptomatic-stenosis-100602162",false,"NCT07119918","PCSK9 Inhibitor for Intracranial Atherosclerotic Symptomatic Stenosis","PCSK9 Inhibitor for Intracranial Atherosclerotic Symptomatic Stenosis (PICASSO): A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Trial","PICASSO","Inclusion Criteria:\n\n1\\. Aged ≥30 years and ≤80 years.\n\nPatients aged between 30 to 49 are required to meet at least one of the following criteria:\n\n1. Insulin dependent diabetes for at least 15 years.\n2. At least 2 of the following atherosclerotic risk factors: hypertension (BP \\> 140\u002F90 or on antihypertensive therapy); dyslipidemia (LDL \\> 130 mg \u002FdL or HDL \\\u003C 40 mg\u002FdL or fasting triglycerides \\> 150 mg\u002FdL or on lipid lowering therapy); smoking; non-insulin dependent diabetes or insulin dependent diabetes of less than 15 years duration; family history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, stroke, carotid endarterectomy or stenting, peripheral vascular surgery in parent or sibling who was \\\u003C 55 years of age for men or \\\u003C 65 for women at the time of the event.\n3. History of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, carotid endarterectomy or stenting, or peripheral vascular surgery for atherosclerotic disease.\n4. Any stenosis of an extracranial carotid or vertebral artery, another intracranial artery, subclavian artery, coronary artery, iliac or femoral artery, other lower or upper extremity artery, mesenteric artery, or renal artery that was documented by non-invasive vascular imaging or catheter angiography and is considered atherosclerotic.\n5. Aortic arch atheroma documented by non-invasive vascular imaging or catheter angiography vi. any aortic aneurysm documented by non-invasive vascular imaging or catheter angiography that is considered atherosclerotic.\n\n2\\. Diagnosed with acute ischemic stroke or moderate-to-high risk transient ischemic attack (ABCD2 score ≥4).\n\n3\\. CTA or DSA confirmed intracranial atherosclerotic stenosis \\>50%, which was responsible for the incident.\n\n4\\. The time from symptom onset to initiation of study treatment is within 7 days.\n\n5\\. Signed informed consent.\n\nExclusion Criteria:\n\n1. Baseline NIHSS ≥26.\n2. Suspected cardiogenic ischemic cerebrovascular diseases (e.g., combined with atrial fibrillation, heart valve prosthesis, atrial myxoma, endocarditis, etc.).\n3. Source of symptoms is possible related to ipsilateral carotid disease.\n4. Other ischemic cerebrovascular diseases with specific causes (e.g., aortic dissection, vasculitis, vascular malformation, etc.).\n5. Non-cerebral vascular disease (e.g., intracranial tumors, multiple sclerosis).\n6. Hemorrhagic stroke or hemorrhagic transformation of cerebral infarction before randomization.\n7. Pre-existing contraindications of using PCSK9 inhibitors.\n8. Use of any PCSK9 inhibitors within the past 3 months.\n9. Pregnant or childbearing-age women who have no effective contraceptives or positive pregnancy test records.\n10. Patients who are participating in other trials.\n11. Hepatic or renal dysfunction, defined as AST and\u002For ALT \\>3ULN，eGFR\\\u003C30mL\u002Fmin, or Crea \\>220μmol\u002FL (2.5mg\u002FdL).\n12. Uncontrolled hypertension defined as systolic blood pressure (BP) \\>220mmHg or diastolic BP \\>120mmHg.\n13. Life expectancy is less than 1 year due to severe non-cardiovascular disease.\n14. Angioplasty or stenting procedure is planned before randomization.\n15. Unable to finish the follow-up visit due to geographical factor or other reasons (e.g., dementia, alcoholism, substance abuse, severe mental disease, etc.)","ALL","30 Years","80 Years",{"count":74,"type":75},5276,"ESTIMATED","INTERVENTIONAL",[78],"PHASE3","An investigator-initiated, prospective, multicenter, randomized, double-blind, placebo-controlled trial comparing the 1-year incidence of stroke in patients with AIS or TIA within 7 days who are treated with either placebo or Recaticimab.",[81],"Symptomatic Intracranial Atherosclerotic Stenosis",[83,22],"symptomatic intracranial atherosclerotic stenosis","NOT_YET_RECRUITING","2025-08-06",{"date":87,"type":88},"2025-08-13","ACTUAL",{"date":90,"type":75},"2025-09-01",{"date":92,"type":75},"2029-12-01",{"name":5,"class":6},1]