Clinical Research Directory
Browse clinical research sites, groups, and studies.
INtensive liPid-lowering Therapy for Acute High-risk IntracRanial or Extracranial atheroSclerosis -II (INSPIRES-2)
Sponsor: Beijing Tiantan Hospital
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).
Official title: INtensive liPid-lowering Therapy for Acute High-risk IntracRanial or Extracranial atheroSclerosis -II (INSPIRES-2):A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
Key Details
Gender
All
Age Range
35 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
242
Start Date
2026-02-01
Completion Date
2027-08-30
Last Updated
2026-01-15
Healthy Volunteers
No
Interventions
Tafolecimab
Treatment should be initiated as soon as possible after randomization, with Tafolecimab administered subcutaneously once every two weeks for a total duration of 90 days. All patients received standard lipid-lowering therapy as recommended by stroke secondary prevention guidelines, including intensive statin treatment with or without ezetimibe, administered at maximally tolerated doses.
Placebo
Treatment should be initiated as soon as possible after randomization, with Tafolecimab placebo administered subcutaneously once every two weeks for a total duration of 90 days. All patients received standard lipid-lowering therapy as recommended by stroke secondary prevention guidelines, including intensive statin treatment with or without ezetimibe, administered at maximally tolerated doses.
Locations (1)
Beijing Tiantan Hopital, Capital Medical University
Beijing, China