Actively Recruiting
Efficacy and Safety of PCSK9 Inhibitors in Patients With Large-Artery Atherosclerosis (LAA) Ischemic Stroke
Led by First Affiliated Hospital of Harbin Medical University · Updated on 2026-04-23
1000
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This prospective multicenter cohort study aims to evaluate the effectiveness and safety of early PCSK9 inhibitor therapy in patients with large-artery atherosclerotic ischemic stroke. The study will compare early neurological improvement, lipid-lowering effect, 90-day functional outcome, recurrent cardio-cerebrovascular events, and safety outcomes between patients treated with evolocumab plus statin and those treated with statin alone.
CONDITIONS
Official Title
Efficacy and Safety of PCSK9 Inhibitors in Patients With Large-Artery Atherosclerosis (LAA) Ischemic Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-80 years
- Diagnosed with acute ischemic stroke based on clinical and imaging criteria
- Large-artery atherosclerotic subtype confirmed within 72 hours of stroke onset
- NIHSS score between 4 and 20 before treatment
- Pre-stroke modified Rankin Scale score of 1 or less
- LDL cholesterol level of 1.8 mmol/L or higher before enrollment
- Able to take evolocumab and statin as directed by a physician
- No prior use of PCSK9 inhibitors
- Provided written informed consent or consent from a legal representative
You will not qualify if you...
- Hemorrhagic transformation or other intracranial hemorrhage, except cerebral microbleeds detected only by SWI
- Prior or planned acute endovascular therapy or surgery affecting outcome assessment within 90 days
- Severe cardiac insufficiency (NYHA class III or IV)
- Severe liver dysfunction or severe kidney dysfunction or dialysis requirement
- Platelet count below 100 x 10^9/L
- Pregnancy or breastfeeding
- Participation in another interventional clinical study within 30 days or concurrent study affecting outcomes
- Giant intracranial tumor, giant cerebral aneurysm, or arteriovenous malformation
- Active gastrointestinal ulcers or bleeding tendencies or recent major bleeding
- Pre-existing neurologic or psychiatric disease likely affecting outcome assessment or severe neurologic deficit
- Autoimmune diseases such as systemic sclerosis or lupus
- Active seizures, hypotension, hyperthyroidism, asthma, allergic respiratory diseases, or allergy tendency
- Any other condition judged by the investigator to pose substantial risk or make participation inappropriate
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Harbin, Heilongjiang, China, 150001
Heilongjiang, China
Actively Recruiting
Research Team
Z
Zhongling Zhang
CONTACT
S
Shanshan Yang
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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