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

Официальное название

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

Обзор

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.

Подробное описание

As a prospective, multicenter, open-label, randomized controlled clinical study, EAST-LDL will enroll 652 patients with acute ischemic stroke with anterior circulation large vessel occlusion undergoing endovascular treatment from approximately 10 clinical sites in China. This study aims to evaluate the effects of functional outcome according to an ordinal analysis of the full range of scores on the mRS, safety of lipid-lowering therapy, LDL-C goal attainment rate, change in inflammatory markers, incidence of recurrent ischemic stroke events , incidence of symptomatic intracranial hemorrhage transformation within 48 hours, incidence of new-onset hemorrhagic stroke, and incidence of MACEs in patients between early intensive lipid-lowering therapy with PCSK9 inhibitor and guideline-recommended standard of care treatment.

Вмешательства

• Препарат guideline-recommended SoC
  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.
• Препарат Recaticimab (intensive)
  Recaticimab is added to the guideline-recommended SoC. After randomization and before endovascular interventional treatment, patients will receive a subcutaneous injection of Recaticimab. The specific method is: Recaticimab 450 mg (3 vials) as a single subcutaneous injection, until the end of the follow-up for this study.

Первичные конечные точки

• favorable functional outcome (defined as an mRS score of 0-2) [Срок оценки: Day 90]

Вторичные конечные точки (12)

• mRS ordinal score [Срок оценки: Day 90]
• Change from baseline in NIHSS score [Срок оценки: Day 14±3 days or before discharge]
• Change from baseline in LDL-C [Срок оценки: Day 14±3 days or before discharge]
• Change in inflammatory markers [Срок оценки: Day 0, Day 14±3 days or before discharge]
• Rate of severe disability(defined as mRS score of 3-5) [Срок оценки: Day 90]
• Incidence of recurrent ischemic stroke events [Срок оценки: From enrollment to the end of treatment at 90 days]
• Incidence of symptomatic intracranial hemorrhage transformation [Срок оценки: Within 24-48 hours]
• Incidence of patients with new hemorrhagic stroke [Срок оценки: From enrollment to 90 days]
• Incidence of patients with major adverse cardiovascular events [Срок оценки: From enrollment to 90 days]
• Number of patients with serious adverse events [Срок оценки: From enrollment to 90 days]
• Health related quality of life [Срок оценки: Day 90]
• NIHSS score [Срок оценки: at 14±3 days or before discharge]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai East Hospital, Tongji University — Шанхай

Идентификаторы

NCT: NCT07002476 · MA-CVD-II-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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