INtensive liPid-lowering Therapy for Acute High-risk IntracRanial or Extracranial atheroSclerosis… (NCT07341958) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
INtensive liPid-lowering Therapy for Acute High-risk IntracRanial or Extracranial atheroSclerosis -II (INSPIRES-2)
China242 participantsStarted 2026-02-01
Plain-language summary
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 (≥50 mg/dL).
Who can participate
Age range35 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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) ≥50 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:
✓.The patient or their legally authorized representative has provided written informed consent.
Exclusion criteria
✕. Patients who have undergone or are scheduled to undergo thrombolysis or thrombectomy therapy.