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.
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).
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;
Parallel
guideline-recommended SoC
DrugGuideline-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)
Drug450 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.
favorable functional outcome (defined as an mRS score of 0-2)
the rate (%) of good functional outcome at 90 days (modified Rankin Scale \[mRS\] score 0-2). Modified Rankin Scale scores of 0 or 1 indicate good function without or with symptoms but not disability, score of 2 indicates slight disability but independence, 3 to 5 indicate increasing levels of disability (and dependency), and a score of 6 indicates death.
mRS ordinal score
Modified Rankin Scale scores of 0 or 1 indicate good function without or with symptoms but not disability, score of 2 indicates slight disability but independence, 3 to 5 indicate increasing levels of disability (and dependency), and a score of 6 indicates death.
Change from baseline in NIHSS score
0-42, higher scores indicates worse severity
Change from baseline in LDL-C
Change from baseline in LDL-C at 14±3 days or before discharge
Change in inflammatory markers
Change from baseline in inflammatory markers at 14±3 days or before discharge;
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