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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorNanjing First Hospital, Nanjing Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

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