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NCT06870448

PHASE3

Methylprednisolone 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 vascular occlusion (LVO) patients with a large infarct core. In this study, the investigators assume that methylprednisolone plus endovascular thrombectomy (EVT) might be superior to EVT alone for patients who have evidence of a large infarct volume. The objective of the study was to establish the efficacy and safety of methylprednisolone with EVT in patients presenting with symptoms of acute ischemic stroke from LVO in the anterior circulation and having a large infarct volume.

Official title: Methylprednisolone With Endovascular Thrombectomy for Large Ischemic Stroke (MATCH): A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1614

Start Date

2025-04

Completion Date

2029-04

Last Updated

2025-03-11

Healthy Volunteers

Conditions

Acute Ischemic Stroke

Interventions

DRUG

Methyprednisolone sodium succinate

Methylprednisolone at a dose of 2 mg/kg/day for 3 consecutive days, with a maximum daily dose of 160 mg (4 vials, 40 mg per vial, Hanhui Pharmaceutical Co., Ltd.). The initial study drug will be administered as soon as possible after randomization. It is recommended that the initial study drug be administered before arterial access closure.

DRUG

Placebo

Placebo for 3 consecutive days, with a maximum daily dose of 4 vials (Hanhui Pharmaceutical Co., Ltd.)

Inclusion Criteria: * 1\. Age ≥18 years; * 2\. Clinically diagnosed with acute ischemic stroke and NIHSS ≥6; * 3\. CT angiography (CTA), MR angiography (MRA) or digital subtraction angiography (DSA) confirmed occlusion of intracranial internal carotid artery (ICA) or M1/M2 segments of middle cerebral artery (MCA) and plan to undergo EVT; * 4\. ASPECTS ≤5 (based on NCCT) or infarct core volume ≥70mL (defined as rCBF \<30% on CT perfusion or ADC \<620 on MRI); * 5\. Time from symptom onset to randomization within 24 hours (from last known well); * 6\. Pre-stroke mRS score 0-2; * 7\. Written informed consent signed by patients or their family members. Exclusion Criteria: * 1\. Intracranial hemorrhage confirmed by CT or MRI; * 2\. Allergic to glucocorticoids or placebo components; * 3\. Allergic to contrast agent; * 4\. Presence of severe infectious disease unsuitable for glucocorticoid therapy or any other contraindication to glucocorticoid use; * 5\. Known genetic or acquired coagulopathy, coagulation factor deficiency, use of warfarin with an international normalized ratio (INR) \>1.7, or use of novel oral anticoagulants within 48 hours of symptom onset; * 6\. Platelet count \<90×10\^9/L; * 7\. Random blood glucose \<2.8 mmol/L or \>22.2 mmol/L; * 8\. History of gastrointestinal or urinary tract bleeding within the last month; * 9\. Current participation in another interventional clinical study; * 10\. Pregnant or lactating women; * 11\. Renal dysfunction (glomerular filtration rate \<30 ml/min or serum creatinine \>220 μmol/L \[2.5 mg/dl\]); * 12\. Uncontrolled hypertension with persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg, refractory to medical management; * 13\. Life expectancy less than 6 months due to malignancy or severe cardiopulmonary disease; * 14\. Other conditions deemed unsuitable for the study by the investigator, such as inability to comprehend or comply with study procedures or follow-up due to mental illness, cognitive or emotional disorder.

Locations (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China