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

Primary Purpose

Intracranial Artery Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PCSK9 inhibitor
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Artery Stenosis focused on measuring symptomatic intracranial atherosclerotic stenosis, stroke, blood lipid management, PCSK9 inhibitors

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  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

Sites / Locations

  • Nanjing First Hospital, Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Recurrent stroke
the recurrent rate of clinical stroke

Secondary Outcome Measures

Intracranial arterial
Degree of change in intracranial arterial stenosis
Plaque changes
Plaque volume and load changes
Vascular remodeling index
Vascular remodeling index changes
Adverse events
The incidence of muscle related events, allergic reactions, injection site reactions, bleeding events and other adverse events was assessed

Full Information

First Posted
May 23, 2022
Last Updated
July 21, 2023
Sponsor
Nanjing First Hospital, Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05397405
Brief Title
Improving Blood Lipid Management in Symptomatic Intracranial Atherosclerotic Stenosis on Clinical Outcome
Acronym
sICASBLM
Official Title
A Prospective Observational Study on the Effect of Improving Blood Lipid Management on the Clinical Prognosis of Symptomatic Intracranial Atherosclerotic Stenosis（sICASBLM）
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2022 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Artery Stenosis
Keywords
symptomatic intracranial atherosclerotic stenosis, stroke, blood lipid management, PCSK9 inhibitors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Blood Lipid management with atorvastatin 20-40mg or rosuvastatin 10-20mg or simvastatin 20-40mg and PCSK9 inhibitors for 6-12 months
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Blood Lipid management with atorvastatin 20-40mg or rosuvastatin 10-20mg or simvastatin 20-40mg for 6-12 months
Intervention Type
Drug
Intervention Name(s)
PCSK9 inhibitor
Other Intervention Name(s)
intensive blood lipid lowing
Intervention Description
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
Primary Outcome Measure Information:
Title
Recurrent stroke
Description
the recurrent rate of clinical stroke
Time Frame
6 months-12 months
Secondary Outcome Measure Information:
Title
Intracranial arterial
Description
Degree of change in intracranial arterial stenosis
Time Frame
6 months or 12 months
Title
Plaque changes
Description
Plaque volume and load changes
Time Frame
6 months or 12 months
Title
Vascular remodeling index
Description
Vascular remodeling index changes
Time Frame
6 months or 12 months
Title
Adverse events
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junshan Zhou
Phone
8602587726218
Email
zhjsh333@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qiwen Deng
Phone
8602587726218
Email
qiw_deng@163.com
Facility Information:
Facility Name
Nanjing First Hospital, Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junshan Zhou, M.D.
Phone
+86025-87726218
Email
zhjsh333@126.com
First Name & Middle Initial & Last Name & Degree
Qiwen Deng, M.D.
Phone
+86025-87726218
Email
qiw_deng@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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