Ischemic Stroke
Conditions
Interventions
Experimental group:PCSK9 inhibitor intensive lipid-lowering therapy: subcutaneous injection of PCSK9i
Control group:Guidelines recommend standard therapy and do not allow intensive lipid lowering with PCSK9i
Sponsors
Shanghai East Hospital, School of Medicine, Tongji University.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults (aged 18 years and above); 2. Acute ischemic stroke diagnosed with occlusion of large vessels in the anterior circulation (including: internal carotid artery, middle cerebral artery M1 and M2, anterior cerebral artery A1 and A2) on imaging; 3. Intend to undergo endovascular interventional surgery within 24 hours of symptom onset (or last known) according to local guidelines; 4. Provide informed consent from the patient himself or the patient's representative (or by an appropriate agent as required by the locality).
Exclusion criteria
Exclusion criteria: 1. The ASPECT score of brain CT on imaging 2 points; 3. Subjects who are allergic to PCSK9 inhibitors; 4. Subjects who received PCSK9 monoclonal antibody within 1 month or PCSK9 siRNA treatment within half a year before enrollment; 5. Severe renal insufficiency, defined as estimated glomerular filtration rate (eGFR) 3 times normal; 7. Severe, concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 3 months; 8. Pregnant or lactating women; 9. Patients who are currently participating in other clinical research trials; 10. Other conditions judged by the investigator to be unsuitable for inclusion in clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Good functional prognosis rate (modified Rankin score (mRS 0-2)%); | — |
Secondary
| Measure | Time frame |
|---|---|
| mRS ordinal score at 90 days;NIHSS score at 14±3 days or before discharge;Change from baseline in NIHSS score at 14±3 days or before discharge;LDL-C target attainment rate at 14±3 days or before discharge;Change from baseline in LDL-C at 14±3 days or before discharge;Change from baseline in inflammatory markers at 14±3 days or before discharge;Rate of severe disability (mRS score 3-5) at 90 days;Mortality rate (mRS score of 6) at 90 days;Incidence of recurrent ischemic stroke events within 90 days;Incidence of symptomatic intracranial hemorrhage transformation within 24-48h;Incidence of new hemorrhagic stroke within 90 days;Incidence of major adverse cardiovascular events (MACEs) within 90 days;Safety assessment;Quality of life scale (EQ-5D) at 90 days; | — |
Countries
China
Contacts
Public ContactGang Li
Shanghai East Hospital, School of Medicine, Tongji University
Outcome results
None listed