NCT05397405

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

May 23, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

April 15, 2026

Status Verified

January 1, 2026

Enrollment Period

3.9 years

First QC Date

May 23, 2022

Last Update Submit

April 10, 2026

Conditions

Intracranial Artery Stenosis

Keywords

symptomatic intracranial atherosclerotic stenosisstrokeblood lipid managementPCSK9 inhibitors

Outcome Measures

Primary Outcomes (1)

  • Recurrent stroke

    the recurrent rate of clinical stroke

    6 months-12 months

Secondary Outcomes (4)

  • Intracranial arterial

    6 months or 12 months

  • Plaque changes

    6 months or 12 months

  • Vascular remodeling index

    6 months or 12 months

  • Adverse events

    6 months or 12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

PCSK9 inhibitorDRUG

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
Intervention group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210006, China

RECRUITING

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Junshan Zhou

CONTACT

8602587726218zhjsh333@126.com

Qiwen Deng

CONTACT

8602587726218qiw_deng@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2022

First Posted

May 31, 2022

Study Start

May 23, 2022

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

April 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)