Intra-arterial Methylprednisolone After Successful Endovascular Thrombectomy Anterior Circulation Large Vessel Occlusion

Обзор

The purpose of IMPACT-LVO trial is to investigate the efficacy and safety of early adjunctive intra-arterial combined with intravenous administration methylprednisolone sodium succinate after successful endovascular thrombectomy in anterior circulation large vessel occlusion patients. This is a multicenter, randomized, double-blind, placebo-controlled trial. Acute ischemia stroke patients with anterior circulation large vessel occlusion within 24 hours from last known well will be screened for this trial. Successful recanalization after mechanical thrombectomy (eTICI 2b-3) patients will be randomized 1:1 to either methylprednisolone sodium succinate group or placebo group. The methylprednisolone sodium succinate group patients will receive intra-arterial methylprednisolone sodium succinate 40mg immediately after the recanalization. Then, intravenous administration with methylprednisolone sodium succinate 2mg/kg in the next 3 days. The placebo group patients will receive intra-arterial and intravenous sterile water for injection. The shift on modified Rankin Scale score is designed to detect in the present trial. A sample size of n = 1010 patients (n=505 per group) is required. The intention-to-treat principle will be applied to the primary analysis, therefore, to safeguard against dilution of the treatment effect associated with an approximate 5% non-adherence rate (due to loss to follow-up, consent withdrawal and other reasons), we planned to enrol n=1060 patients (n=530 per group) for this study. The findings of IMPACT-LVO are likely to have a direct impact on clinical practice.

Вмешательства

• Препарат The methylprednisolone sodium succinate
  Patients will receive intra-arterial methylprednisolone sodium succinate 40mg immediately after the recanalization from thrombectomy in anterior circulation large vessel occlusion. Then, intravenous administration with methylprednisolone sodium succinate 2mg/kg in the next 3 days.
• Препарат Placebo
  The placebo group patients will receive intra-arterial and intravenous sterile water for injection.

Первичные конечные точки

• Shift in the distribution of mRS scores [Срок оценки: 90 days]
• Incidence of symptomatic intracranial hemorrhage [Срок оценки: 48 hours]
• Mortality [Срок оценки: 90 days]

Вторичные конечные точки (12)

• The proportion of mRS score 0 to 4 [Срок оценки: 90 days]
• The proportion of mRS score 0 to 3 [Срок оценки: 90 days]
• The proportion of mRS score 0 to 2 [Срок оценки: 90 days]
• mRS scores [Срок оценки: 1 year]
• The incidence of malignant brain edema [Срок оценки: within 48 hours]
• Changes of NIHSS score [Срок оценки: 5-7 days after surgery]
• EQ-5D scale score [Срок оценки: 90 days]
• EQ-5D scale score [Срок оценки: 1 year]
• Proportion of patients with any radiologic intracranial haemorrhage [Срок оценки: within 48 hours after treatment]
• Proportion of patients with pneumonia [Срок оценки: within 7 days after the treatment]
• Proportion of patients with gastrointestinal haemorrhage [Срок оценки: within 7 days after treatment]
• Incidence of non-hemorrhagic serious adverse events [Срок оценки: within 7 days after treatment]

Критерии участия

Критерии включения

• Age 18-80 years old; 2) The time from onset to randomization was within 24 hours; 3) Large vessel occlusive stroke in the anterior circulation confirmed by CTA/MRA/DSA (Including intracranial segment of internal carotid artery, M1 or M2 segment of middle cerebral artery) and the vessel responsible for the signs and symptoms of acute ischemic stroke; 4) NIHSS score >= 6 points 5) Alberta Stroke Program Early Diagnosis (ASPECTS) score of NCCT >=3; 6) Successful endovascular thrombectomy (eTICI 2b50-3) 7) Written informed consent signed by patients or their family members

Критерии исключения

• Intracranial hemorrhage confirmed by computed tomography (CT) or magnetic resonance imaging (MRI);
• Prestroke mRS score >= 2
• pregnant or lactating patients
• Allergy to iodinated contrast media, or methylprednisolone sodium succinate
• Participating in other clinical research;
• Inherited/acquired hemorrhagic diathesis (coagulation factor deficiency) or oral anticoagulation with international normalized ratio (INR) >1.7
• History of major bleeding within the past 1 month (gastrointestinal/genitourinary hemorrhage)
• Chronic hemodialysis and severe renal insufficiency (glomerular filtration rate < 30ml/min/1.73m\^2 or serum creatinine > 220μmol/L (2.5mg/dl));
• Terminal illness with life expectancy <6 months;
• Blood glucose < 2.8mmol/L (50mg/dl) or > 22.2mmol/L (400mg/dl);
• Intracranial aneurysm, arteriovenous malformation, or space-occupying brain tumor with mass effect on imaging
• Active systemic infectious disease
• Anticipated inability to complete follow-up
• Intraoperative DSA showed vascular perforation, dissection, and contrast extravasation;
• Puncture to recanalization was more than 90 minutes; Total thrombectomy passes >3

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tangdu Hospital — Сиань

Идентификаторы

NCT: NCT07141303 · K202508-15

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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