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

Sponsor: Shanghai East Hospital • ClinicalTrials.gov ID: NCT07002476

Registry updated: 2026-09-02

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Description

EAST-LDL is a prospective, multicenter, randomized, open-label clinical trial with blinded endpoint assessment evaluating whether early intensive lipid lowering with the PCSK9 inhibitor recaticimab, administered before endovascular therapy, improves functional outcome in patients with acute ischemic stroke due to anterior-circulation large-vessel occlusion. Participants are randomized to recaticimab plus guideline-recommended standard of care or standard of care alone. The primary outcome is favorable functional outcome, defined as a modified Rankin Scale score of 0-2 at 90 ± 7 days.

Interventions

guideline-recommended SoC (Drug)
Guideline-recommended SoC, including but not limited to oral lipid-lowering drugs, antiplatelet aggregation drugs, anticoagulant drugs, antihypertensive drugs, etc. It is to be determined by the investigator based on the subject's treatment needs.
Recaticimab (intensive) (Drug)
450 mg as three 150-mg subcutaneous injections after randomization and before the first thrombectomy pass. No additional PCSK9 inhibitor treatment is planned during the 90-day follow-up.

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.

Conditions

Stroke

Locations

Shanghai East Hospital, Tongji University — Shanghai, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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