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A prospective interventional open-label clinical study of PCSK9 inhibitors in the treatment of acute symptomatic intracranial arterial stenosis

A prospective, open-label, randomized, controlled clinical trial of PCSK9 inhibitors in the treatment of acute symptomatic intracranial arterial stenosis

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081186
Enrollment
Unknown
Registered
2024-02-26
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

cerebrovascular disease

Interventions

inventory group:Evolocumab 420mg q4w subcutaneous injection combined with statin (atorvastatin 20mg) treatment
control group:Statin therapy (atorvastatin 20mg)

Sponsors

Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Sign the informed consent form 2) 80 years old = patient age = 18 years old 3) For patients diagnosed with non-cardiogenic ischemic stroke/transient ischemic attack, the time of stroke is <14 days from enrollment. Patients diagnosed with ischemic stroke by head CT or magnetic resonance imaging (MRI) 4) Brain MRA/CTA/DSA confirms severe intracranial artery stenosis (70%-99%) 5) hematology test ?20000/mm3=white blood cell count=4000/mm3 ?Neutrophils =1500/mm3 ?Platelet count =100000/mm3 ?Hemoglobin =110g/L ?Normal range of coagulation function 6) laboratory examination ?Total bilirubin, AST, ALT=1.0X the upper limit of normal values ?Creatinine clearance 80~120ml/min ?Urine microprotein is normal

Exclusion criteria

Exclusion criteria: 1) Previous history of hemorrhagic stroke; 2) Have a history of kidney disease; 3) Have a history of heart failure; 4) Have a history of malignant tumors in the past 10 years; 5) The patient also suffers from other uncontrolled serious diseases, such as severe infection, arrhythmia, congestive heart failure diabetes, severe mental and behavioral abnormalities, etc.; 6) Patients with obvious intracranial hypertension and midline shift requiring emergency surgery; 7) History of gastrointestinal ulcer and gastrointestinal bleeding; 8) Patients with a history of allergies or adverse reactions to trial drugs.

Design outcomes

Primary

MeasureTime frame
Atherosclerotic plaque morphological assessment;

Countries

China

Contacts

Public ContactLei He

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

helei523@hotmail.com+86 135 6005 6821

Outcome results

None listed

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