Methylprednisolone With Endovascular Thrombectomy for Large Ischemic Stroke

NCT06870448 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: SYS-5010-202501
• Study Type: interventional
• Target: 1,614
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Ischemic Stroke

Keywords

large infarct core; methylprednisolone; endovascular thrombectomy

Outcome Measures

Primary Outcomes (1)

• 90-day distribution of patients across the ordinal modified Rankin Scale (mRS)

  The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. Score 0: No symptoms. Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms. Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Score 6: Dead

  90±14 days after randomization

Secondary Outcomes (8)

• modified Rankin Scale (mRS) 0-1 at 90±14 days

  90±14 days after randomization

• modified Rankin Scale (mRS) 0-2 at 90±14 days

  90±14 days after randomization

• modified Rankin Scale (mRS) 0-3 at 90±14 days

  90±14 days after randomization

• modified Rankin Scale (mRS) 0-4 at 90±14 days

  90±14 days after randomization

• Quality of Life (EuroQoL 5-Dimension 5-Level) at 90±14 days

  90±14 days after randomization

Other Outcomes (4)

• All-cause mortality within 90 days (Safety Outcome)

  90±14 days after randomization

• Time to all-cause mortality within 90 days (Safety Outcome)

  Randomization up to 90±14 days after randomization

• Rate of symptomatic intracranial hemorrhage (sICH) per Heidelberg Bleeding Classification within 48 hours (Safety Outcome)

  36±12 hours after randomization

Study Arms (2)

Methylprednisolone group

EXPERIMENTAL

Methylprednisolone sodium succinate

Drug: Methyprednisolone sodium succinate

Placebo group

PLACEBO COMPARATOR

Methylprednisolone sodium succinate simulant

Drug: Placebo

Interventions

Methyprednisolone sodium succinate DRUG

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.

Also known as: Methylprednisolone

Methylprednisolone group

Placebo DRUG

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

Also known as: Methylprednisolone sodium succinate simulant

Placebo group

Eligibility Criteria

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

You may qualify if:

• \. Age ≥18 years;
• \. Clinically diagnosed with acute ischemic stroke and NIHSS ≥6;
• \. 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;
• \. ASPECTS ≤5 (based on NCCT) or infarct core volume ≥70mL (defined as rCBF \<30% on CT perfusion or ADC \<620 on MRI);
• \. Time from symptom onset to randomization within 24 hours (from last known well);
• \. Pre-stroke mRS score 0-2;
• \. Written informed consent signed by patients or their family members.

You may not qualify if:

• \. Intracranial hemorrhage confirmed by CT or MRI;
• \. Allergic to glucocorticoids or placebo components;
• \. Allergic to contrast agent;
• \. Presence of severe infectious disease unsuitable for glucocorticoid therapy or any other contraindication to glucocorticoid use;
• \. 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;
• \. Platelet count \<90×10\^9/L;
• \. Random blood glucose \<2.8 mmol/L or \>22.2 mmol/L;
• \. History of gastrointestinal or urinary tract bleeding within the last month;
• \. Current participation in another interventional clinical study;
• \. Pregnant or lactating women;
• \. Renal dysfunction (glomerular filtration rate \<30 ml/min or serum creatinine \>220 μmol/L \[2.5 mg/dl\]);
• \. Uncontrolled hypertension with persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg, refractory to medical management;
• \. Life expectancy less than 6 months due to malignancy or severe cardiopulmonary disease;
• \. 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.

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

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

• Qingyu Shen

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinguang Yang

CONTACT

86 + 13078895666; yangxinguang0926@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: March 6, 2025
• First Posted: March 11, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after the trial completion
• Access Criteria: The IPD will be available from principal investigator upon reasonable request.

Locations

CN (1)