[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ischemic-stroke-or-high-risk-tia-abcd--4\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ischemic-stroke-or-high-risk-tia-abcd--4":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100619233","intensive-lipid-lowering-therapy-for-acute-high-risk-intracranial-or-extracranial-atherosclerosis--ii-inspires-2-100619233",false,"NCT07341958","INtensive liPid-lowering Therapy for Acute High-risk IntracRanial or Extracranial atheroSclerosis -II (INSPIRES-2)","INtensive liPid-lowering Therapy for Acute High-risk IntracRanial or Extracranial atheroSclerosis -II (INSPIRES-2)：A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial","Inclusion Criteria:\n\n1. Age between 35 and 80 years, regardless of gender.\n2. For patients with prior lipid-lowering treatment: screening LDL-C ≥1.8 mmol\u002FL; for treatment-naïve patients: screening LDL-C ≥2.6 mmol\u002FL.\n3. Lp(a) ≥30 mg\u002FdL.\n4. Onset of symptoms within 3 to 7 days.\n5. Diagnosis of ischemic stroke (NIHSS score ≤20) or high-risk TIA with ABCD² score ≥4; and meeting at least one of the following imaging criteria:\n\n(1) Large-artery atherosclerosis (LAA) subtype per TOAST classification: vascular imaging confirms ≥50% atherosclerotic stenosis of the intracranial or extracranial culprit artery.\n\n(2) Head CT or MRI demonstrates acute multiple infarcts, with etiology consistent with large-artery atherosclerosis (including nonstenotic vulnerable plaques).\n\n6.The patient or their legally authorized representative has provided written informed consent.\n\nExclusion Criteria:\n\n1. Have received or are planned to receive intravenous thrombolysis or endovascular thrombectomy;\n2. Definite cardioembolic ischemic cerebrovascular disease, such as that associated with atrial fibrillation, prosthetic heart valves, atrial myxoma, endocarditis, etc.;\n3. Ischemic cerebrovascular disease with other definite etiologies, such as aortic dissection, cervical or intracranial arterial dissection, vasculitis, vascular malformation, moyamoya disease\u002Fmoyamoya syndrome, fibromuscular dysplasia, etc.;\n4. Non-vascular intracranial diseases, such as intracranial tumors, multiple sclerosis, etc.;\n5. Neuroimaging showing that the infarct area of the index cerebral infarction involves more than one-half of a single cerebral lobe;\n6. Neuroimaging showing hemorrhagic transformation of the index cerebral infarction;\n7. Pre-stroke modified Rankin Scale (mRS) score \\>1;\n8. Known hypersensitivity to tafolecimab or any other contraindication to its use;\n9. Use of immunosuppressive agents, antifungal agents, fibrates, or other medications that may affect statin metabolism within 14 days prior to randomization;\n10. Creatine kinase (CK) level \\>5 times the upper limit of normal (ULN) after symptom onset;\n11. Severe hepatic or renal impairment prior to randomization. Severe hepatic impairment is defined as alanine aminotransferase (ALT) \\>2 times the ULN or aspartate aminotransferase (AST) \\>2 times the ULN; severe renal impairment is defined as serum creatinine \\>1.5 times the ULN or glomerular filtration rate (GFR) \\\u003C40 mL\u002Fmin\u002F1.73 m²;\n12. History of intracranial hemorrhage, such as intracerebral hemorrhage (ICH) or subarachnoid hemorrhage (SAH);\n13. History of intracranial or extracranial angioplasty;\n14. History of gastrointestinal bleeding or major surgery within the previous 90 days;\n15. Planned surgery or interventional procedure within 90 days that may require discontinuation of the study treatment;\n16. Severe organic disease with an expected survival of less than 1 year;\n17. Pregnant women, or women of childbearing potential who are not using effective contraception and have no documented pregnancy test;\n18. Currently participating in another clinical trial involving an investigational drug or device;\n19. Unable to complete follow-up due to geographic or other reasons, such as alcohol abuse, drug abuse, dementia, or severe psychiatric disorders;\n20. Use of a PCSK9 inhibitor, including monoclonal antibodies or small interfering RNA (siRNA), within the previous 6 months;\n21. Thrombocytopenia (platelet count \\\u003C100 × 10⁹\u002FL), coagulation disorders, or systemic bleeding.","ALL","35 Years","80 Years",{"count":20,"type":21},242,"ESTIMATED","INTERVENTIONAL",[24],"NA","The research team is conducting a randomized, double-blind, placebo-controlled, multicenter clinical study aimed at evaluating the impact of adding Tolecilimab (a PCSK9 inhibitor) to standard lipid-lowering therapy (statins ± ezetimibe) on serum lipoprotein(a) \\[Lp(a)\\] levels and the risk of stroke recurrence within 90 days in patients with ischemic stroke or high-risk TIA (ABCD² ≥ 4) accompanied by elevated lipoprotein(a) levels (≥30 mg\u002FdL).",[27],"Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)",[29,30,31],"PCSK9 inhibitor","lipid-lowering therapy","ischemic stroke","NOT_YET_RECRUITING","2026-10-05",{"date":35,"type":36},"2026-10-08","ACTUAL",{"date":38,"type":21},"2026-09-08",{"date":40,"type":21},"2027-08-30",{"name":42,"class":43},"Beijing Tiantan Hospital","OTHER"]