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The Effect of InTensive Statin in Ischemic Stroke With inTracranial Atherosclerotic Plaques

Study acronym: INSIST-HRMRI
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary and study completion dates: Nov 30, 2026 to Nov 30, 2027v9
  2. Notable Primary and study completion dates: Nov 30, 2024 to Nov 30, 2026v8
  3. Minor Re-verified, no change to tracked fieldsv7
  4. Notable Primary completion date: Nov 30, 2022 to Nov 30, 2024
    • Study completion date: Nov 30, 2023 to Nov 30, 2024
    v6
  5. Minor Interventions: Atorvastatin Calcium (Drug), Atorvastatin Calcium (Drug), Probucol (Drug) to Atorvastatin Calcium (Drug), Atorvastatin Calcium (Drug), PCSK9 inhibitor (Drug), Probucol (Drug)v5
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  1. Notable Primary completion date: Nov 30, 2020 to Nov 30, 2022
    • Study completion date: Nov 30, 2021 to Nov 30, 2023
    v4
  2. Minor Re-verified, no change to tracked fieldsv3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Intracranial atherosclerotic disease is the most common cause of ischemic stroke that is directly attributed to the progression or rupture of intracranial high-risk plaque in Asia. Many studies mainly from Euro-American population with a focus on extracranial carotid plaque have fully demonstrated the advantages of intensive statin therapy on stabilizing or reversing plaque burden, reversing plaque composition presenting that lipid-rich necrotic core (LRNC) is gradually replaced by fibrous tissue, and even reversing pattern of arterial remodeling to reduce the occurrence of cerebrovascular events. Yet, direct evidence of the effect of intensive statin therapy on intracranial atherosclerotic plaques is lacking and the effect of statin intensity and duration on intracranial plaque burden and composition is still unclear. High resolution magnetic resonance imaging (HRMRI) is a new and non-invasive technique that enable to assess the morphologic characteristics of vascular wall and plaque composition of intracranial artery. Based on above discussion, the investigators conduct this study to further determine the effect of intensive statin in ischemic stroke with intracranial atherosclerotic plaques.
Trial Details
NCT Number NCT03753555
Lead Sponsor General Hospital of Shenyang Military Region
Conditions
(from sponsor)
Stroke, Ischemic, Atherosclerosis, Cerebral
Related terms Intracranial Arteriosclerosis, Ischemic Stroke
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov