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RecruitingNCT05397405sICASBLMUpdated Apr 15, 2026

Improving Blood Lipid Management in Symptomatic Intracranial Atherosclerotic Stenosis on Clinical Outcome

An interventional study of PCSK9 inhibitor in Intracranial Artery Stenosis, sponsored by Nanjing First Hospital, Nanjing Medical University. Recruiting at 2 sites in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-04-15.

Sponsored by Nanjing First Hospital, Nanjing Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started May 2022; still recruiting 4 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
All
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Study summary

sICASBLM is a prospective controlled trial, to asses the impact of improving blood lipid management on clinical outcome of moderate to severe symptomatic intracranial atherosclerotic stenosis patients (LDL-C>1.8mmol/L) without endovascular therapy.

Read the detailed description

sICASBLM aims to determine the effectiveness of conventional lipid management combined with PCSK9 inhibitors compared to conventional lipid management (atorvastatin 20-40mg or rosuvastatin 10-20mg or simvastatin 20-40mg) in reducing the incidence of recurrent stroke in patients with moderate to severe symptomatic intracranial atherosclerotic stenosis (LDL-C>1.8mmol/L) without endovascular therapy.

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Conditions studied

  • Intracranial Artery Stenosis

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Keywords

  • symptomatic intracranial atherosclerotic stenosis
  • stroke
  • blood lipid management
  • PCSK9 inhibitors
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's planned enrollment of 180 is above the median of 50 across 5,366 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Nanjing First Hospital, Nanjing Medical University is the lead sponsor of 213 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥18 years
  2. Symptomatic intracranial atherosclerotic stenosis of moderate to severe, did not receive intravenous thrombolysis, thrombectomy, stent implantation and other intravascular treatment
  3. low density lipoprotein cholesterol > 70mg/dl (1.8mmol/L)
  4. Receive 3T magnetic resonance angiography or multi-mode MR (high resolution is required), angiography can be included, and images for analysis can be obtained.
  5. Lipid-lowering indications of statins
  6. Signed an approved informed consents

Exclusion criteria

Exclusion Criteria:

  1. Contraindications to statins
  2. There are contraindications to MRI examination or cannot accept MRI examination
  3. Stenosis caused by vasculitis, arterial dissection and moyamoya disease
  4. Patients with active bleeding or obvious bleeding tendency
  5. Severe heart, lung, renal insufficiency, malignant tumor or other malignant diseases, and death is highly likely within 7 days; pregnancy or women who are lactating
  6. Uncontrolled severe diabetes and hypertension
  7. Other conditions inappropriate for inclusion judged by investigators
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    Intervention group

    Blood Lipid management with atorvastatin 20-40mg or rosuvastatin 10-20mg or simvastatin 20-40mg and PCSK9 inhibitors for 6-12 months

    Drug: PCSK9 inhibitor

  • No intervention
    Control group

    Blood Lipid management with atorvastatin 20-40mg or rosuvastatin 10-20mg or simvastatin 20-40mg for 6-12 months

Interventions

  • DrugPCSK9 inhibitor

    The aim is to improve blood lipid management by using atorvastatin 20-40mg or rosuvastatin 10-20mg or simvastatin 20-40mg and PCSK9 inhibitors for 6-12 months

    Also known as: intensive blood lipid lowing

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What researchers measure

Primary outcomes

  1. Recurrent stroke

    the recurrent rate of clinical stroke

    Time frame: 6 months-12 months

Secondary outcomes

  1. Intracranial arterial

    Degree of change in intracranial arterial stenosis

    Time frame: 6 months or 12 months

  2. Plaque changes

    Plaque volume and load changes

    Time frame: 6 months or 12 months

  3. Vascular remodeling index

    Vascular remodeling index changes

    Time frame: 6 months or 12 months

  4. Adverse events

    The incidence of muscle related events, allergic reactions, injection site reactions, bleeding events and other adverse events was assessed

    Time frame: 6 months or 12 months

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Study locations

2 of 2 sites recruiting
  • Nanjing First Hospital, Nanjing Medical University
    Nanjing, Jiangsu 210006, China
    Recruiting
  • Nanjing First Hospital
    Nanjing, Jiangsu 210006, China
    Recruiting
08

References and documents

Publications

  • Li Z, Sun C, Zhang Q, Ji L, Zhang Y, Li S, Gu M, Gao J, Huang Z, Wang M, Zhou J, Zhu L, Jiang T, Zhou Q, Deng Q. Impact of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitor on Immune-Inflammatory Responses in the Acute Phase of Ischemic Stroke. J Inflamm Res. 2026 Apr 30;19:590179. doi: 10.2147/JIR.S590179. eCollection 2026. PubMed 42089099 ↗
  • Li Z, Liu X, Sun H, Jiang X, Zhang Y, Ji L, Zhang L, Wang M, Gu M, Li S, Zhang Y, Liu Y, Shi H, Jiang T, Mei Y, Zhu L, Zhou J, Deng Q. Predictors for recurrent ischemic stroke in patients with watershed infarct induced by intracranial artery stenosis. Clin Neurol Neurosurg. 2025 Jul;254:108897. doi: 10.1016/j.clineuro.2025.108897. Epub 2025 Apr 18. PubMed 40288288 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05397405
Lead sponsor
Nanjing First Hospital, Nanjing Medical University
Responsible party
Sponsor
First posted
May 31, 2022
Start date
May 23, 2022
Primary completion
May 1, 2026 (estimated)
Completion
May 1, 2026 (estimated)
Last update
Apr 15, 2026

Study contacts

Junshan Zhou
Contact
zhjsh333@126.com
8602587726218
Qiwen Deng
Contact
qiw_deng@163.com
8602587726218

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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