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NCT07175649

Methylprednisolone Sodium Succinate With Endovascular ThRombectomy for Large Ischemic STroke

Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

View on ClinicalTrials.gov

Summary

It is uncertain whether intravenous methylprednisolone improves outcomes for acute anterior circulation large vessel occlusion (LVO) patients with a large infarct core. In this study, the investigators hypothesize that methylprednisolone plus endovascular thrombectomy (EVT) might be superior to EVT alone in patients with evidence of a large infarct volume. The primary objective of the study is to establish the efficacy of methylprednisolone with EVT in patients with acute anterior circulation LVO and a large infarct core.

Official title: Methylprednisolone Sodium Succinate With Endovascular ThRombectomy for Large Ischemic STroke: A Randomized, Double-blind, Placebo-controlled Trial

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

912

Start Date

2025-10

Completion Date

2029-12

Last Updated

2025-09-16

Healthy Volunteers

Conditions

Ischemic Stroke, Acute

Interventions

DRUG

Methylprednisolone sodium succinate

Intravenous methylprednisolone sodium succinate will be administered at a dose of 2 mg/kg/day for 3 days, with a maximum daily dose of 160 mg (4 vials, 40 mg/vial). It is recommended that the initial dose be administered as soon as possible after randomization.

DRUG

Placebo

Matched intravenous placebo will be administered for 3 days, with a maximum daily dose of 4 vials.

Inclusion Criteria: * Aged 18 to 85 years; * Clinically diagnosed acute ischemic stroke with screening NIHSS ≥6; * Time from last known well to randomization ≤24 hours; * Pre-stroke mRS score of 0-1; * Occlusion of the responsible vessel confirmed by CT angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA) in intracranial segment of internal carotid artery (ICA), M1 or M2 segment of middle cerebral artery (MCA), and plan to undergo EVT; * Alberta Stroke Program Early CT Score (ASPECTS) of 0-5 on NCCT, or ischemic core volume ≥70 mL (defined as regional cerebral blood flow \[rCBF\] \<30% on CT perfusion \[CTP\] or apparent diffusion coefficient \[ADC\] \<620×10-⁶ mm²/s on MRI); * Informed consent obtained. Exclusion Criteria: * Intracranial hemorrhage on NCCT or MRI; * Allergy to corticosteroids; * Allergy to contrast agents; * Severe infectious disease unsuitable for corticosteroid therapy or concurrent contraindications to corticosteroid treatment; * Random blood glucose \>22.2 mmol/L (400 mg/dL); * Known hereditary or acquired bleeding diathesis, coagulation factor deficiency, use of warfarin with an international normalized ratio (INR) \>1.7, or administration of novel oral anticoagulants within 48 hours of symptom onset; * Platelet count \<90×10⁹/L; * History of gastrointestinal or urinary tract bleeding within the last month; * Current participation in another interventional clinical trial; * Pregnancy or lactating; * Renal dysfunction with an estimated glomerular filtration rate (eGFR) \<30 mL/min or serum creatinine \>220 μmol/L (2.5 mg/dL); * Persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg despite antihypertensive treatment; * Life expectancy \<6 months due to terminal illnesses such as malignancy or severe cardiopulmonary disease; * Intracranial aneurysm or arteriovenous malformation; * Intracranial tumour with mass effect on imaging (except for small meningiomas); * Other conditions deemed unsuitable for study participation by the investigator, including inability to comprehend and/or comply with study procedures and/or follow-up due to psychiatric, cognitive, or emotional disorders.

Locations (1)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China