Tests tafolecimab added to cholesterol medicine after stroke or mini-stroke

Trial details

Who runs it

Beijing Tiantan Hospital

Trial code

NCT07341958

Record updated

8 October 2026

Original description

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/dL).Read full original descriptionShow less

INtensive liPid-lowering Therapy for Acute High-risk IntracRanial or Extracranial atheroSclerosis -II (INSPIRES-2)：A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

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/dL).

Inclusion: Age between 35 and 80 years, regardless of gender; For patients with prior lipid-lowering treatment: screening LDL-C ≥1.8 mmol/L; for treatment-naïve patients: screening LDL-C ≥2.6 mmol/L; Lp(a) ≥30 mg/dL; Onset of symptoms within 3 to 7 days; 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:; (1) Large-artery atherosclerosis (LAA) subtype per TOAST classification: vascular imaging confirms ≥50% atherosclerotic stenosis of the intracranial or extracranial culprit artery; (2) Head CT or MRI demonstrates acute multiple infarcts, with etiology consistent with large-artery atherosclerosis (including nonstenotic vulnerable plaques); 6.The patient or their legally authorized representative has provided written informed consent.

Exclusion: Have received or are planned to receive intravenous thrombolysis or endovascular thrombectomy; Use of immunosuppressive agents, antifungal agents, fibrates, or other medications that may affect statin metabolism within 14 days prior to randomization; History of gastrointestinal bleeding or major surgery within the previous 90 days; Planned surgery or interventional procedure within 90 days that may require discontinuation of the study treatment; Currently participating in another clinical trial involving an investigational drug or device; Use of a PCSK9 inhibitor, including monoclonal antibodies or small interfering RNA (siRNA), within the previous 6 months; Definite cardioembolic ischemic cerebrovascular disease, such as that associated with atrial fibrillation, prosthetic heart valves, atrial myxoma, endocarditis, etc; Ischemic cerebrovascular disease with other definite etiologies, such as aortic dissection, cervical or intracranial arterial dissection, vasculitis, vascular malformation, moyamoya disease/moyamoya syndrome, fibromuscular dysplasia, etc; Non-vascular intracranial diseases, such as intracranial tumors, multiple sclerosis, etc; Pre-stroke modified Rankin Scale (mRS) score >1; Known hypersensitivity to tafolecimab or any other contraindication to its use; History of intracranial hemorrhage, such as intracerebral hemorrhage (ICH) or subarachnoid hemorrhage (SAH); History of intracranial or extracranial angioplasty; Severe organic disease with an expected survival of less than 1 year; Unable to complete follow-up due to geographic or other reasons, such as alcohol abuse, drug abuse, dementia, or severe psychiatric disorders; Creatine kinase (CK) level >5 times the upper limit of normal (ULN) after symptom onset; 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) <40 mL/min/1.73 m²; Thrombocytopenia (platelet count <100 × 10⁹/L), coagulation disorders, or systemic bleeding; Neuroimaging showing that the infarct area of the index cerebral infarction involves more than one-half of a single cerebral lobe; Neuroimaging showing hemorrhagic transformation of the index cerebral infarction; Pregnant women, or women of childbearing potential who are not using effective contraception and have no documented pregnancy test.

ClinicalTrials.gov NCT07341958