Early intensive LDL‑lowering with a PCSK9 inhibitor before thrombectomy for large‑vessel ischemic stroke

A Prospective, Multicenter, Open-Label, Randomized Controlled Study of Early Intensive Lipid-Lowering in Endovascular Treatment for Acute Ischemic Stroke

This trial will test whether starting intensive LDL‑cholesterol lowering with a PCSK9 inhibitor before endovascular thrombectomy helps adults with acute anterior‑circulation large‑vessel ischemic stroke recover better.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 652 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai East Hospital (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT07002476 on ClinicalTrials.gov

What this trial studies

EAST‑LDL is a prospective, multicenter, open‑label, randomized controlled Phase 3 study enrolling about 652 adults with acute anterior‑circulation large‑vessel occlusion stroke who are planned for endovascular treatment within 24 hours. Participants are randomized to receive preoperative intensive lipid‑lowering with a PCSK9 inhibitor (recaticimab) versus guideline‑recommended standard of care. The co‑primary focuses include functional outcome across the full range of the modified Rankin Scale and safety endpoints; secondary measures include LDL‑C goal attainment, inflammatory marker changes, recurrent ischemic events, symptomatic intracranial hemorrhage, new hemorrhagic stroke, and major adverse cardiovascular events. The trial is being conducted at roughly 10 sites in China, with centralized outcome analyses and ordinal mRS comparison as the primary analytic approach.

Who should consider this trial

Good fit: Adults aged 18 or older with acute anterior‑circulation large‑vessel occlusion planned for endovascular treatment within 24 hours, able to provide consent (or with a legal representative), without recent PCSK9 therapy or severe baseline disability, are ideal candidates.

Not a fit: Patients with very low ASPECTS (≤5), pre‑stroke disability (mRS >2), allergy to PCSK9 inhibitors, recent PCSK9 therapy, or severe renal failure (eGFR <15 mL/min/1.73 m2) are unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, early intensive LDL lowering could improve functional recovery and reduce recurrent ischemic events after endovascular therapy for large‑vessel stroke.

How similar studies have performed: PCSK9 inhibitors have shown clear long‑term cardiovascular benefit in chronic atherosclerotic disease, but using them acutely before thrombectomy for stroke is a novel approach that has not yet been proven.

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.

Where this trial is running

Shanghai

• Shanghai East Hospital, Tongji University — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Gang Li, MD

Conditions Stroke; acute ischemic stroke; LDL-Cholersterol lowering; Endovascular Therapy; PCSK9; clinical trials