Early Aggressive Strategy for Treatment of Lipid-Lowering in Acute Ischemic Stroke Delivered With Endovascular Therapy for Large Artery Occlusion

Launched by SHANGHAI EAST HOSPITAL · Jun 2, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating whether starting a strong cholesterol-lowering treatment early, before a specific type of stroke intervention called endovascular therapy, can improve recovery in patients who have had an acute ischemic stroke. The treatment being tested is a medication known as a PCSK9 inhibitor, which helps lower cholesterol levels. Researchers want to compare the effects of this aggressive treatment to the standard care that is usually provided. The goal is to see if this early intervention can lead to better outcomes for patients.

To be eligible for the trial, participants must be adults aged 18 or older who have been diagnosed with an acute ischemic stroke affecting certain large blood vessels in the brain and are planning to undergo the endovascular therapy within 24 hours of their symptoms starting. However, there are some exclusions, such as those with severe kidney or liver issues, significant pre-existing health problems, or who are currently pregnant. If someone qualifies and agrees to participate, they can expect to receive either the new cholesterol-lowering treatment or the standard treatment and will be monitored closely throughout the study. It's an important opportunity to contribute to research that could improve stroke care in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults (age 18 years and older);
• • Imaging diagnosis of acute ischemic stroke with anterior circulation large vessel occlusion (including: internal carotid artery, middle cerebral artery M1 and M2, anterior cerebral artery A1 and A2);
• • Planned to undergo endovascular intervention within 24 hours of symptom onset (or last known well time) according to local guidelines;
• • Provision of informed consent by the patient or his/her legally authorized representative (or by an appropriate agent according to local requirements).
• Exclusion Criteria:
• • ASPECTS score ≤5 on cranial CT imaging;
• • Pre-existing functional impairment, with mRS score \>2;
• • Patients who are allergic to PCSK9 inhibitors;
• • Patients who have received PCSK9 monoclonal antibody within 1 month prior to enrollment or PCSK9 siRNA therapy within 6 months prior to enrollment;
• • Severe renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \< 15 mL/min/1.73m2 at final screening;
• • Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 times the upper limit of normal;
• • Severe, concomitant non-cardiovascular disease expected to reduce life expectancy to less than 3 months;
• • Pregnant or lactating women;
• • Patients who are participating in other clinical trials;
• • Other conditions deemed unsuitable for inclusion in the clinical study by the investigator.