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Recruiting Phase 3 NCT07002476

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

Trial Parameters

Condition Stroke
Sponsor Shanghai East Hospital
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 652
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-06-19
Completion 2028-06-01
Interventions
guideline-recommended SoCRecaticimab (intensive)

Brief Summary

A prospective, multicenter, open-label, randomized controlled study to assess the effects of early intensive lipid-lowering initiated before endovascular treatment setting on (i) functional outcome in patients with acute ischemic stroke between preoperative intensive lipid-lowering therapy with PCSK9 inhibitor (PCSK9i) and guideline-recommended standard of care (SoC)(ii) safety in these patients.

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

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