INtensive liPid-lowering Therapy for Acute High-risk IntracRanial or Extracranial atheroSclerosis -II (INSPIRES-2)

StatusNot Yet Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
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Record History

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  1. Notable Primary endpoint(s) modified Show 4 more changesShow less
    • Start date: Feb 1, 2026 to Sep 8, 2026
    • Eligibility criteria expanded, about 81 words
    • Secondary endpoints: details revised at 10 of 17 entries
    • Study description revised
  2. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
3,537 trials monitored
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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).
Trial Details
NCT Number NCT07341958
Lead Sponsor Beijing Tiantan Hospital
Conditions
(from sponsor)
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)
Related terms Ischemic Stroke
Enrollment 242 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov