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NCT Number: NCT05397405

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing First Hospital, Nanjing, Jiangsu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Contraindications to statins
  • There are contraindications to MRI examination or cannot accept MRI examination
  • Stenosis caused by vasculitis, arterial dissection and moyamoya disease
  • Patients with active bleeding or obvious bleeding tendency
  • 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
  • Uncontrolled severe diabetes and hypertension
  • Other conditions inappropriate for inclusion judged by investigators

Treatment and study plan

PCSK9 inhibitor

Drug

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

Other names: intensive blood lipid lowing

Primary outcomes

  1. Recurrent stroke

    Time frame: 6 months-12 months

    the recurrent rate of clinical stroke

Secondary outcomes

  1. Intracranial arterial

    Time frame: 6 months or 12 months

    Degree of change in intracranial arterial stenosis

  2. Plaque changes

    Time frame: 6 months or 12 months

    Plaque volume and load changes

  3. Vascular remodeling index

    Time frame: 6 months or 12 months

    Vascular remodeling index changes

  4. Adverse events

    Time frame: 6 months or 12 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Junshan Zhou

CONTACT

[email protected]

8602587726218

Qiwen Deng

CONTACT

[email protected]

8602587726218

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

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

Acronym: sICASBLM

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 31, 2022
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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