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 range
35 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on reducing a specific blood marker called Lp(a) — can you test my Lp(a) level now to help us understand whether that's a significant factor in my stroke or TIA risk?
2Since this trial is listed as 'not yet recruiting,' how long might it be before it opens, and is there a similar already-active study or a standard treatment approach we should pursue in the meantime given how urgent my situation is after a stroke or TIA?
3The trial seems focused on measuring a 90-day reduction in Lp(a) levels rather than directly measuring stroke recurrence — can you explain what that means for what we'd actually learn about my safety and long-term benefit if I were eventually to participate?
4This trial is Phase NA, which makes it harder for me to know how much safety data already exists — what do we currently know about the risks of intensive lipid-lowering therapy targeting Lp(a) specifically, versus the standard statin treatment I might otherwise receive?
5Given that my TIA or stroke was classified as high-risk, would waiting to see if this trial opens put me at greater risk, or are there proven treatments we should start right now that wouldn't conflict with potentially joining this study later?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The percentage reduction in Lp(a) from baseline at 90 days.
Timeframe: From baseline to 90 days after randomization