Methylprednisolone Adjunctive to Endovascular Thrombectomy for Stroke

Phase 3Active Not RecruitingNCT06360458

Wan-Jin Chen928 enrolled

Overview

The efficacy and safety of methylprednisolone in acute ischemic stroke patients with large infarct cores (ASPECTS score \< 6 or infarct volume ≥50 mL) due to anterior circulation large vessel occlusion have not been clearly established. This is a multi-center, randomized, double-blind, placebo-controlled trial to investigate early combination therapy with methylprednisolone for reperfusion in acute large core infarction.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

928

Conditions

Acute Ischemic Stroke Large Infarct Core

Interventions

Methylprednisolone sodium succinateDRUG

Intravenous injection of methylprednisolone sodium succinate (Chongqing Lummy Pharmaceutical Co., Ltd., 40mg/bottle) with a dose of 2mg/kg (maximum dose of 160mg), once daily, for three consecutive days. The initial study drug will be administered as soon as possible after randomization. It is recommended that the initial study drug administrated before arterial access closure, but it should not be delayed more than 2 hours after arterial access closure.

PlaceboDRUG

Intravenous injection of placebo (Chongqing Lummy Pharmaceutical Co., Ltd., 40mg/bottle) with a dose of 2mg/kg (maximum dose of 160mg), once daily, for three consecutive days. The initial study drug will be administered as soon as possible after randomization. It is recommended that the initial study drug administrated before arterial access closure, but it should not be delayed more than 2 hours after arterial access closure.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years. * The time from onset to randomization was within 12 hours. * Anterior circulation ischemic stroke was preliminarily determined according to clinical symptoms or imaging examination. * Occlusion of the intracranial internal carotid artery, the M1- or M2-segment of the middle cerebral artery by confirmed by CT angiography (CTA), MR angiography (MRA), or digital subtraction angiography (DSA). * Baseline National Institutes of Health Stroke Scale (NIHSS) ≥ 6. * Baseline Alberta Stroke Program Early CT Score (ASPECTS) \< 6 (based on non-contrast CT or MRI) and/or core infarct volume ≥ 50 ml (based on CTP with rCBF \< 30%). * Planned treatment with endovascular thrombectomy (EVT). * Informed consent obtained from patients or their legal representatives. Exclusion Criteria: * Intracranial hemorrhage confirmed by cranial CT or MRI. * mRS score \> 2 before onset. * Pregnant or lactating women. * Allergic to contrast agents or glucocorticoids. * Participating in other clinical trials. * The artery is tortuous so that the thrombectomy device cannot reach the target vessel. * Bleeding history (gastrointestinal and urinary tract bleeding) in recent 1 month. * Chronic hemodialysis and severe renal insufficiency (glomerular filtration rate \< 30 ml/min or serum creatinine \> 220 umol/L \[2.5 mg/ dL\]). * Life expectancy due to any advanced disease \< 6 months. * Follow-up is not expected to be completed. * Intracranial aneurysm and arteriovenous malformation. * Brain tumors with imaging mass effect. * Systemic infectious disease.

Locations (99)

Outcomes

Primary Outcomes

All-cause mortality at 90 (±14) days

Primary Efficacy Outcome. Defined as the number of any cause deaths observed divided by the number of subjects observed over the 90-day study period.