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PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke

Study acronym: PISTIAS-3
StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Peking Union Medical College Hospital

Record History

  1. Primary endpoint(s) modified Interventions: Recaticimab plus placebo in combination with standard therapy (Drug), Rucacuzumab plus standard therapy (Drug) to Recaticimab plus standard therapy (Drug), Recaticimab's placebo in combination with standard therapy (Drug) · Eligibility criteria shortened, about 24 words · Secondary endpoints: 7 to 12v2 Show 3 more changesShow less
    • Interventions: Recaticimab plus placebo in combination with standard therapy (Drug), Rucacuzumab plus standard therapy (Drug) to Recaticimab plus standard therapy (Drug), Recaticimab's placebo in combination with standard therapy (Drug)
    • Eligibility criteria shortened, about 24 words
    • Secondary endpoints: 7 to 12

    See this version in full on ClinicalTrials.gov ↗

  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is a prospective, multicenter, double-blind, randomized, placebo-controlled clinical trial designed to evaluate whether early administration of PCSK9 inhibitors can effectively improve functional outcomes at 90 days in patients with ischemic stroke (AIS) associated with intracranial atherosclerotic stenosis (ICAS), primarily assessed using the modified Rankin Scale at 90 days.
Trial Details
NCT Number NCT07466251
Lead Sponsor Peking Union Medical College Hospital
Collaborators: Chinese PLA General Hospital, Hebei General Hospital, Taihe Hospital, Weifang People's Hospital, Nanjing First Hospital, Nanjing Medical University, Baotou Central Hospital, Jining First People's Hospital, Liaocheng People's Hospital, Tangshan Worker's Hospital, Chongqing General Hospital, First Affiliated Hospital of Harbin Medical University, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine, The First Affiliated Hospital of Zhengzhou University, The Affiliated Hospital of Qingdao University, Zhongnan Hospital, Huashan Hospital
Conditions Acute Ischemic Stroke AIS, Intracranial Atherosclerosis ICAS, Atherosclerotic Plaque
Enrollment 1,212 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov