Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
ID05397405

A Prospective Observational Study on the Effect of Improving Blood Lipid Management on the Clinical Prognosis of Symptomatic Intracranial Atherosclerotic Stenosis (sICASBLM)

Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2026-04-15

180

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating how improving blood lipid management affects the clinical outcomes of patients with moderate to severe symptomatic intracranial atherosclerotic stenosis who have LDL cholesterol levels above 1.8 mmol/L and are not undergoing endovascular therapy. The study compares conventional lipid management alone to conventional lipid management combined with PCSK9 inhibitors to see if this approach can reduce recurrent strokes. Participants receive either conventional lipid management with statins (atorvastatin, rosuvastatin, or simvastatin) or the same treatment plus PCSK9 inhibitors for 6 to 12 months. The study groups include an intervention group receiving the combined treatment and a control group receiving only statins. No randomization or masking is involved, and the study is observational in design. Throughout the study, participants will be monitored for recurrent stroke occurrences between 6 and 12 months. Researchers will also assess intracranial arterial conditions, plaque changes, vascular remodeling, and any adverse events during this period. The study involves imaging with 3T magnetic resonance angiography or multi-mode MR scans, along with clinical evaluations and safety monitoring. The total participation duration is up to 12 months, with data collection focused on clinical outcomes and vascular health.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Moderate to severe symptomatic intracranial atherosclerotic stenosis without previous intravenous thrombolysis, thrombectomy, stent implantation, or other intravascular treatment
  • Low density lipoprotein cholesterol (LDL-C) greater than 70 mg/dl (1.8 mmol/L)
  • Completed 3T magnetic resonance angiography or multi-mode MR with images suitable for analysis
  • Indications for lipid-lowering statin therapy
  • Signed approved informed consent
Not Eligible

You will not qualify if you...

  • Contraindications to statin use
  • Contraindications to MRI or inability to undergo MRI examination
  • Stenosis caused by vasculitis, arterial dissection, or moyamoya disease
  • Active bleeding or significant bleeding tendency
  • Severe heart, lung, or renal failure, malignant tumors, or conditions with high risk of death within 7 days
  • Pregnancy or breastfeeding
  • Uncontrolled severe diabetes or hypertension
  • Other conditions deemed unsuitable for inclusion by investigators

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 to 12 months

Participants receive blood lipid management with atorvastatin, rosuvastatin, or simvastatin, with or without PCSK9 inhibitors, for 6 to 12 months to reduce the incidence of recurrent stroke.

Visits scheduled according to treatment and monitoring needs

Trial Site Locations

Total: 2 locations

1

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, China, 210006

Actively Recruiting

2

Nanjing First Hospital

Nanjing, Jiangsu, China, 210006

Actively Recruiting

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Research Team

J

Junshan Zhou

Q

Qiwen Deng

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Impact of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitor on Immune-Inflammatory Responses in the Acute Phase of Ischemic Stroke.

Zhenzhen Li, Cong Sun, Qing Zhang...

https://pubmed.ncbi.nlm.nih.gov/42089099