An observational study in Acute Ischemic Stroke, sponsored by First Affiliated Hospital of Harbin Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by First Affiliated Hospital of Harbin Medical University · Observational
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.
This is a prospective, multicenter, consecutively enrolling cohort study to be conducted at the First Affiliated Hospital of Harbin Medical University and participating centers in Heilongjiang Province. Eligible patients are adults 18-80 years old with acute ischemic stroke of the large-artery atherosclerotic subtype (TOAST classification), LDL-C ≥1.8 mmol/L, and onset-to-enrollment time ≤72 hours. Participants will be assigned to exposure cohorts according to the actual lipid-lowering treatment initiated in routine clinical care.
The exposed cohort will receive evolocumab 140 mg subcutaneously every 2 weeks or 420 mg monthly, plus daily statin therapy, for 90 days. The non-exposed cohort will receive daily statin therapy alone for 90 days. The planned total enrollment is 1000 participants, targeting approximately 500 participants per cohort. Visits and assessments will be performed at baseline, Day 7 (±2 days) or hospital discharge, Day 30 (±7 days), and Day 90 (±7 days) after stroke onset. The primary outcome is the proportion of participants with favorable functional outcome (mRS 0-2) at Day 90. Safety follow-up continues through Day 90 whenever feasible, even if evolocumab is discontinued.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 300 across 771 observational studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →First Affiliated Hospital of Harbin Medical University is the lead sponsor of 74 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Evolocumab injection. 140 mg subcutaneously every 2 weeks or 420 mg monthly for 90 days. Other treatment: Daily statin therapy according to routine clinical practice
Drug: Statin. Daily statin therapy for 90 days according to routine clinical practice.
Proportion of participants with favorable functional outcome at Day 90
Proportion of participants with modified Rankin Scale (mRS) score 0-2.
Time frame: 90 ± 7 days after stroke onset
Ordinal distribution of mRS at Day 90
Distribution of mRS scores 0-6 at the 90-day follow-up assessment.
Time frame: 90 ± 7 days after stroke onset
Incidence of early neurologic deterioration (END) and severe END
END: increase of ≥2 points in total NIHSS or ≥1 point in motor subscore within 7 days. Severe END: increase of ≥4 points in total NIHSS or ≥2 points in motor subscore within 7 days.
Time frame: Within 7 days after enrollment
Change in NIHSS score from baseline
Change in NIHSS score from baseline to Day 7 (±2 days) or hospital discharge, whichever comes first.
Time frame: Up to Day 7 (±2 days)
Change in LDL-C from baseline
Change in fasting LDL-C concentration from baseline to the Day 30 follow-up assessment.
Time frame: 30 ± 7 days after stroke onset
Recurrent cardio-cerebrovascular events
Incidence of recurrent ischemic stroke, myocardial infarction, or other adjudicated cardio-cerebrovascular events during follow-up.
Time frame: Within 90 days after stroke onset
All-cause mortality
Death from any cause during follow-up
Time frame: Within 90 days after stroke onset
Adverse events
Incidence of adverse events from informed consent through the end of follow-up.
Time frame: From informed consent to Day 90
Serious adverse events
Incidence of serious adverse events from informed consent through the end of follow-up
Time frame: From informed consent to Day 90
Plan to share: Undecided
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Dec 2027, 23 months after the start.
Of 394 non-industry observational studies under Ischemic Stroke, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 140. This study's planned 23 months is below that.
Counting every sponsor, half of 436 studies reached it within 53 months; a quarter within 24 and three quarters within 127.
How these figures are worked out, and which studies are left out of them.
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First Affiliated Hospital of Harbin Medical University