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PCSK9 Inhibitor With Statin Therapy for Asymptomatic Intracranial Atherosclerosis

Study acronym: PISTIAS-2
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date changed from estimate of Sep 1, 2025 to Nov 7, 2025 Eligibility criteria revised · Study description revisedv3 Show 2 more changesShow less
    • Eligibility criteria revised
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Start date: May 1, 2025 to Sep 1, 2025 · Primary endpoint revised · Study sites: 10 to 19 · 5 morev2 Show 8 more changesShow less
    • Start date: May 1, 2025 to Sep 1, 2025
    • Primary endpoint revised
    • Study sites: 10 to 19
    • Secondary endpoints: 8 to 9
    • Study description expanded, about 94 words
    • Collaborators: 9 to 16
    • Publications: details revised at 13 of 13 entries
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a prospective, multicenter, open-label, blinded-endpoint, randomized controlled trial designed to evaluate the efficacy and safety of PCSK9 inhibitor combined with statin therapy compared to statin monotherapy in reversing asymptomatic intracranial atherosclerosis, assessed using high-resolution magnetic resonance imaging of the intracranial vessel walls.
Trial Details
NCT Number NCT06902740
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 Intracranial Atherosclerosis, Intracranial Artery Stenosis, Atherosclerotic Plaque
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov