Could a cholesterol shot boost stroke recovery?
NCT ID NCT07540741
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether adding evolocumab (a powerful cholesterol-lowering drug) to standard statin therapy helps people recover better after a stroke caused by hardening of the large arteries. Researchers will follow 1000 adults aged 18-80 for 90 days, comparing those who get the combination to those who get statin alone. The goal is to see if the combination leads to better daily function and fewer repeat strokes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- evolocumab (a PCSK9 inhibitor) plus statin
- What this could lead to
- If successful, this could show that adding evolocumab to standard statin therapy helps more people recover better after a stroke caused by large-artery atherosclerosis.
- What could go wrong
- This is an observational study, not a randomized trial, so results may be less definitive. The benefit may be small, and there is a risk of side effects like injection-site reactions or muscle pain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population consists of adult patients aged 18-80 years with acute ischemic stroke of the large-artery atherosclerotic (LAA) subtype, confirmed by clinical and imaging criteria within 72 hours of symptom onset. Eligible participants have baseline LDL-C ≥1.8 mmol/L, NIHSS score 4-20, and a pre-stroke modified Rankin Scale (mRS) score ≤1. Patients are consecutively enrolled from multiple tertiary hospitals in Heilongjiang Province during routine clinical care. All participants are candidates for statin therapy, with or without PCSK9 inhibitor (evolocumab), based on the actual clinical diagnosis and treatment plan. Key exclusions include intracranial hemorrhage, severe cardiac insufficiency, severe hepatic or renal dysfunction, major comorbidities affecting outcomes, and prior PCSK9 inhibitor use.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18-80 years. 2. Acute ischemic stroke diagnosed according to the Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke (2023), based on clinical and imaging criteria. 3. Large-artery atherosclerotic subtype (TOAST classification) confirmed within 72 hours after stroke onset. 4. NIHSS score 4-20 before treatment. 5. Pre-stroke modified Rankin Scale (mRS) score ≤1. 6. LDL-C ≥1.8 mmol/L before enrollment. 7. Able to use evolocumab and statin medications in accordance with the physician's instructions and the prescribing information. 8. No prior use of a PCSK9 inhibitor before enrollment. 9. Written informed consent provided by the participant or legally authorized representative. Exclusion Criteria: 1. Hemorrhagic transformation or other intracranial hemorrhage (including hemorrhagic infarction, subarachnoid hemorrhage, subdural hematoma, or epidural hematoma), except cerebral microbleeds detected only by SWI. 2. Prior intracranial or extracranial endovascular therapy before enrollment, planned acute endovascular therapy within 90 days, or planned surgery that may affect outcome assessment. 3. Severe cardiac insufficiency:NYHA class III or IV. 4. Severe hepatic dysfunction (ALT or AST \>3 x upper limit of normal) or severe renal dysfunction (serum creatinine \>2 mg/dL, eGFR \<30 mL/min/1.73 m2, or requiring dialysis). 5. Platelet count \<100 x 10\^9/L. 6. Pregnancy or breastfeeding. 7. Participation in another interventional clinical study within 30 days before enrollment, or concurrent participation in another interventional study that may affect outcome assessment. 8. Giant intracranial tumor, giant cerebral aneurysm, or arteriovenous malformation. 9. Active gastrointestinal ulcer, active bleeding tendency: corrected international normalized ratio (INR) \> 1.5, bleeding time exceeding the upper limit by more than 1 minute, or increased bleeding risk due to heparin-induced thrombocytopenia; major systemic bleeding occurring within 30 days prior to enrollment. 10. Pre-existing neurologic or psychiatric disease likely to affect neurologic or functional outcome assessment; severe neurologic deficit causing loss of independent living; dementia or psychiatric disease preventing completion of follow-up. 11. Autoimmune disease (for example systemic sclerosis, systemic lupus erythematosus, Sjogren syndrome, Behcet disease, mixed connective tissue disease, or IgG4-related disease). 12. Active seizures, hypotension, hyperthyroidism, asthma, and other allergic respiratory diseases, as well as individuals with a tendency toward allergies. 13. Any other condition judged by the investigator to make participation inappropriate or to pose substantial risk.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Harbin, Heilongjiang, China, 150001
RECRUITINGHeilongjiang, China
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