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Effect of PCSK9 inhibitors combined with Statin therapy on short-term lipid-lowering efficacy, early recurrence risk, and degree of stenosis in patients with symptomatic intracranial and extracranial atherosclerotic stenosis: A bidirectional cohort study

Multidimensional investigation of screening, risk factors, prognosis and prevention of ischemic cerebrovascular disease: a comprehensive study based on OCTA, glutamyltransferase, nontraditional lipid parameters, PCSK9 inhibitors, and glucose triglyceride index

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400088792
Enrollment
Unknown
Registered
2024-08-27
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic stroke

Interventions

PCSK9 inhibitor group:NA
control group:NA

Sponsors

The Second Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years; 2. Meet the diagnostic criteria for symptomatic intracranial/extracranial atherosclerotic stenosis; 3. Admitted to the hospital within one week of onset; 4. At the time of admission, have undergone at least one of the following imaging examinations: MRA, CTA, or DSA, and have stenosis of 50-99% in at least one of the following arteries: common carotid artery, internal carotid artery, subclavian artery, middle cerebral artery, vertebral artery, or basilar artery; 5. LDL-C = 1.8 mmol/L.

Exclusion criteria

Exclusion criteria: 1. Stroke caused by non-atherosclerotic stenosis, such as arterial dissection, Moyamoya disease, cardioembolic stroke, and other possible causes such as vasculitis, coagulation disorders, and neoplastic embolism; 2. Lack of complete clinical laboratory or imaging data, or data quality insufficient to assess SIR, or lesions located near arterial bifurcations, trifurcations, or perforating branches, making SIR measurement unsuitable; 3. Received ipsilateral intracranial and/or extracranial arterial angioplasty or thrombectomy within one month prior to enrollment; 4. Severe hepatic insufficiency [alanine aminotransferase (ALT), aspartate aminotransferase (AST) exceeding three times the upper limit of normal], renal impairment [estimated glomerular filtration rate (eGFR) = 30ml/(min·1.73m²)]; 5. Use of PCSK9 inhibitors within six months prior to enrollment; 6. Severe cardiovascular disease, hematological system diseases, respiratory system diseases, malignant tumors, etc.; 7. Refusal or inability to complete follow-up.

Design outcomes

Primary

MeasureTime frame
early recurrent stroke(ERS);

Secondary

MeasureTime frame
low-density lipoprotein cholesterol(LDL-C);signal intensity ratio (SIR);Total Cholesterol(TC) Triglycerides(TG) High-Density Lipoprotein Cholesterol (HDL-C) Lipoprotein(a) Apolipoprotein A1 (ApoA1) Apolipoprotein B (ApoB);

Countries

China

Contacts

Public ContactShuqin Zhan

The Second Affiliated Hospital of Xi'an Jiaotong University

sqzhan@mail.xjtu.edu.cn+86 158 2929 2597

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026