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NCT07175649Not yet recruiting

Methylprednisolone Sodium Succinate With Endovascular ThRombectomy for Large Ischemic STroke

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

Source: ClinicalTrials.gov · Last updated 16 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
912 (estimated)
First submitted
9 Sept 2025
Start date
1 Oct 2025
Primary completion date
31 Dec 2028
Lead sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Diseases
Stroke
NCT number
NCT07175649

What you commit to

  • Study type: Interventional
  • Planned participants: 912
  • From 1 Oct 2025 to the primary completion date, 31 Dec 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Severe infectious disease unsuitable for corticosteroid therapy or concurrent contraindications to corticosteroid treatment;

Other illness

  • Intracranial hemorrhage on NCCT or MRI;
  • Allergy to corticosteroids;
  • Allergy to contrast agents;
  • History of gastrointestinal or urinary tract bleeding within the last month;
  • Life expectancy \<6 months due to terminal illnesses such as malignancy or severe cardiopulmonary disease;
  • 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.

Lab values

  • 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;
  • Renal dysfunction with an estimated glomerular filtration rate (eGFR) \<30 mL/min or serum creatinine \>220 μmol/L (2.5 mg/dL);

Other

  • Current participation in another interventional clinical trial;
  • Pregnancy or lactating;
  • Persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg despite antihypertensive treatment;
  • Intracranial aneurysm or arteriovenous malformation;
  • Intracranial tumour with mass effect on imaging (except for small meningiomas);

Who the study is looking for

  • 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.

Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.