Methylprednisolone Sodium Succinate With Endovascular ThRombectomy for Large Ischemic STroke

NCT07175649 | Not Yet Recruiting DMC

• 1 other identifier: SYSKY-2025-603-03
• Study Type: interventional
• Target: 912
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Stroke, Acute

Outcome Measures

Primary Outcomes (1)

• The modified Rankin Scale score (mRS) 0-3

  The proportion of mRS score 0-3 at 90 (±14) days

  90±14 days after randomization

Secondary Outcomes (8)

• The distribution of the modified Rankin Scale scores

  90±14 days after randomization

• The modified Rankin Scale score (mRS) 0-4

  90±14 days after randomization

• The modified Rankin Scale score (mRS) 0-2

  90±14 days after randomization

• The modified Rankin Scale score (mRS) 0-1

  90±14 days after randomization

• Quality of Life (EQ-5D-5L)

  90±14 days after randomization

Other Outcomes (3)

• SAFETY OUTCOME: Mortality

  90±14 days after randomization

• SAFETY OUTCOME: Symptomatic intracranial hemorrhage (sICH)

  Within 48 hours after randomization

• SAFETY OUTCOME: Any serious adverse events and steroid-related adverse events (hyperglycemia, infection, and gastrointestinal hemorrhage)

  90±14 days after randomization

Study Arms (2)

Methylprednisolone group

EXPERIMENTAL

Drug: Methylprednisolone sodium succinate

Placebo group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Methylprednisolone sodium succinate DRUG

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.

Also known as: Methylprednisolone

Methylprednisolone group

Placebo DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Methylprednisolone Hemisuccinate; Methylprednisolone

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Yamei Tang

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinguang Yang

CONTACT

86 + 13076822010; yangxinguang0926@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 16, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)