Acute Ischemic StrokeNCT07540741
Efficacy and Safety of PCSK9 Inhibitors in Patients With Large-Artery Atherosclerosis (LAA) Ischemic Stroke
An observational study of Acute Ischemic Stroke, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 3 Dec 2025to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age 18-80 years.
- Acute ischemic stroke diagnosed according to the Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke (2023), based on clinical and imaging criteria.
- Large-artery atherosclerotic subtype (TOAST classification) confirmed within 72 hours after stroke onset.
- NIHSS score 4-20 before treatment.
- Pre-stroke modified Rankin Scale (mRS) score ≤1.
- LDL-C ≥1.8 mmol/L before enrollment.
Show all 9Show fewer
- Able to use evolocumab and statin medications in accordance with the physician's instructions and the prescribing information.
- No prior use of a PCSK9 inhibitor before enrollment.
- Written informed consent provided by the participant or legally authorized representative.
Who cannot join
- Hemorrhagic transformation or other intracranial hemorrhage (including hemorrhagic infarction, subarachnoid hemorrhage, subdural hematoma, or epidural hematoma), except cerebral microbleeds detected only by SWI.
- Prior intracranial or extracranial endovascular therapy before enrollment, planned acute endovascular therapy within 90 days, or planned surgery that may affect outcome assessment.
- Severe cardiac insufficiency：NYHA class III or IV.
- 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).
- Platelet count <100 x 10^9/L.
- Pregnancy or breastfeeding.
Show all 13Show fewer
- Participation in another interventional clinical study within 30 days before enrollment, or concurrent participation in another interventional study that may affect outcome assessment.
- Giant intracranial tumor, giant cerebral aneurysm, or arteriovenous malformation.
- 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.
- 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.
- Autoimmune disease (for example systemic sclerosis, systemic lupus erythematosus, Sjogren syndrome, Behcet disease, mixed connective tissue disease, or IgG4-related disease).
- Active seizures, hypotension, hyperthyroidism, asthma, and other allergic respiratory diseases, as well as individuals with a tendency toward allergies.
- Any other condition judged by the investigator to make participation inappropriate or to pose substantial risk.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Harbin, Heilongjiang, China, 150001
Heilongjiang
Zhongling Zhang, +8613503615988, zhang777hyd@163.com
About this study
Official title: Efficacy and Safety of PCSK9 Inhibitors in Patients With Large-Artery Atherosclerosis (LAA) Ischemic Stroke: A Prospective Multicenter Cohort Study
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.
Read the detailed description
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.
- Conditions
- Acute Ischemic Stroke
- Keywords
- PCSK9 inhibitor, Cohort study, Large-Artery Atherosclerotic, Functional outcome
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Exposed | 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 | |
| Non-exposed | Drug: Statin. Daily statin therapy for 90 days according to routine clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with favorable functional outcome at Day 90
Proportion of participants with modified Rankin Scale (mRS) score 0-2.
Measured: 90 ± 7 days after stroke onset
Secondary outcomes (6)
Ordinal distribution of mRS at Day 90
Distribution of mRS scores 0-6 at the 90-day follow-up assessment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 90 days after stroke onset
All-cause mortality
Death from any cause during follow-up
Measured: Within 90 days after stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start3 Dec 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongling Zhang, First Affiliated Hospital of Harbin Medical University
- Investigators
- Zhongling Zhang, Principal investigator, First Affiliated Hospital, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540741
- Sponsor's protocol ID
- 2025143
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of PCSK9 Inhibitors in Patients With Large-Artery Atherosclerosis (LAA) Ischemic Stroke: A Prospective Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT07540741
- Acronym / sponsor ID
- 2025143
- Conditions
- Acute Ischemic Stroke
- Keywords
- PCSK9 inhibitor, Cohort study, Large-Artery Atherosclerotic, Functional outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed | – | –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 |
| Non-exposed | – | –Drug: Statin. Daily statin therapy for 90 days according to routine clinical practice. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (9 listed)
- Age 18-80 years.
- Acute ischemic stroke diagnosed according to the Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke (2023), based on clinical and imaging criteria.
- Large-artery atherosclerotic subtype (TOAST classification) confirmed within 72 hours after stroke onset.
- NIHSS score 4-20 before treatment.
- Pre-stroke modified Rankin Scale (mRS) score ≤1.
Key exclusion criteria (13 listed)
- Hemorrhagic transformation or other intracranial hemorrhage (including hemorrhagic infarction, subarachnoid hemorrhage, subdural hematoma, or epidural hematoma), except cerebral microbleeds detected only by SWI.
- Prior intracranial or extracranial endovascular therapy before enrollment, planned acute endovascular therapy within 90 days, or planned surgery that may affect outcome assessment.
- Severe cardiac insufficiency：NYHA class III or IV.
- 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).
- Platelet count <100 x 10^9/L.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of participants with favorable functional outcome at Day 90
Time frame: 90 ± 7 days after stroke onset
Proportion of participants with modified Rankin Scale (mRS) score 0-2.
6 secondary outcomes
Ordinal distribution of mRS at Day 90
Time frame: 90 ± 7 days after stroke onset
Incidence of early neurologic deterioration (END) and severe END
Time frame: Within 7 days after enrollment
Change in NIHSS score from baseline
Time frame: Up to Day 7 (±2 days)
Change in LDL-C from baseline
Time frame: 30 ± 7 days after stroke onset
Recurrent cardio-cerebrovascular events
Time frame: Within 90 days after stroke onset
All-cause mortality
Time frame: Within 90 days after stroke onset
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhongling Zhang principal investigator
First Affiliated Hospital, Harbin Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhongling Zhang (+8613503615988, zhang777hyd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with favorable functional outcome at Day 90 (time frame: 90 ± 7 days after stroke onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.