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

Phase 4

• Conditions: Ischemic stroke

• Registration Number: ChiCTR2400088792
• Lead Sponsor: The Second Affiliated Hospital of Xi'an Jiaotong University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Aged 18-80 years;<br>2. Meet the diagnostic criteria for symptomatic intracranial/extracranial atherosclerotic stenosis;<br>3. Admitted to the hospital within one week of onset;<br>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;<br>5. LDL-C = 1.8 mmol/L.

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;<br>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;<br>3. Received ipsilateral intracranial and/or extracranial arterial angioplasty or thrombectomy within one month prior to enrollment;<br>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)];<br>5. Use of PCSK9 inhibitors within six months prior to enrollment;<br>6. Severe cardiovascular disease, hematological system diseases, respiratory system diseases, malignant tumors, etc.;<br>7. Refusal or inability to complete follow-up.

Study & Design

• Study Type: Observational study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
early recurrent stroke(ERS);

Secondary Outcome Measures

Name	Time	Method
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);