Intra-arterial Methylprednisolone After Successful Endovascular Thrombectomy Anterior Circulation Large Vessel Occlusion

NCT07141303 | Recruiting Phase 3 DMC

• 1 other identifier: K202508-15
• Study Type: interventional
• Target: 1,060
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of IMPACT-LVO trial is to investigate the efficacy and safety of early adjunctive intra-arterial combined with intravenous administration methylprednisolone sodium succinate after successful endovascular thrombectomy in anterior circulation large vessel occlusion patients. This is a multicenter, randomized, double-blind, placebo-controlled trial. Acute ischemia stroke patients with anterior circulation large vessel occlusion within 24 hours from last known well will be screened for this trial. Successful recanalization after mechanical thrombectomy (eTICI 2b-3) patients will be randomized 1:1 to either methylprednisolone sodium succinate group or placebo group. The methylprednisolone sodium succinate group patients will receive intra-arterial methylprednisolone sodium succinate 40mg immediately after the recanalization. Then, intravenous administration with methylprednisolone sodium succinate 2mg/kg in the next 3 days. The placebo group patients will receive intra-arterial and intravenous sterile water for injection. The shift on modified Rankin Scale score is designed to detect in the present trial. A sample size of n = 1010 patients (n=505 per group) is required. The intention-to-treat principle will be applied to the primary analysis, therefore, to safeguard against dilution of the treatment effect associated with an approximate 5% non-adherence rate (due to loss to follow-up, consent withdrawal and other reasons), we planned to enrol n=1060 patients (n=530 per group) for this study. The findings of IMPACT-LVO are likely to have a direct impact on clinical practice.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (3)

• Shift in the distribution of mRS scores

  90 days

• Incidence of symptomatic intracranial hemorrhage

  48 hours

• Mortality

  90 days

Secondary Outcomes (12)

• The proportion of mRS score 0 to 4

  90 days

• The proportion of mRS score 0 to 3

  90 days

• The proportion of mRS score 0 to 2

  90 days

• mRS scores

  1 year

• The incidence of malignant brain edema

  within 48 hours

Study Arms (2)

The methylprednisolone sodium succinate group

EXPERIMENTAL

The methylprednisolone sodium succinate group patients will receive intra-arterial methylprednisolone sodium succinate 40mg immediately after the recanalization. Then, intravenous administration with methylprednisolone sodium succinate 2mg/kg in the next 3 days.

Drug: The methylprednisolone sodium succinate

The placebo group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

The methylprednisolone sodium succinate DRUG

Patients will receive intra-arterial methylprednisolone sodium succinate 40mg immediately after the recanalization from thrombectomy in anterior circulation large vessel occlusion. Then, intravenous administration with methylprednisolone sodium succinate 2mg/kg in the next 3 days.

The methylprednisolone sodium succinate group

Placebo DRUG

The placebo group patients will receive intra-arterial and intravenous sterile water for injection.

The placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years old; 2) The time from onset to randomization was within 24 hours; 3) Large vessel occlusive stroke in the anterior circulation confirmed by CTA/MRA/DSA (Including intracranial segment of internal carotid artery, M1 or M2 segment of middle cerebral artery) and the vessel responsible for the signs and symptoms of acute ischemic stroke; 4) NIHSS score \>= 6 points 5) Alberta Stroke Program Early Diagnosis (ASPECTS) score of NCCT \>=3; 6) Successful endovascular thrombectomy (eTICI 2b50-3) 7) Written informed consent signed by patients or their family members

You may not qualify if:

• Intracranial hemorrhage confirmed by computed tomography (CT) or magnetic resonance imaging (MRI);
• Prestroke mRS score \>= 2
• pregnant or lactating patients
• Allergy to iodinated contrast media, or methylprednisolone sodium succinate
• Participating in other clinical research;
• Inherited/acquired hemorrhagic diathesis (coagulation factor deficiency) or oral anticoagulation with international normalized ratio (INR) \>1.7
• History of major bleeding within the past 1 month (gastrointestinal/genitourinary hemorrhage)
• Chronic hemodialysis and severe renal insufficiency (glomerular filtration rate \< 30ml/min/1.73m\^2 or serum creatinine \> 220μmol/L (2.5mg/dl));
• Terminal illness with life expectancy \<6 months;
• Blood glucose \< 2.8mmol/L (50mg/dl) or \> 22.2mmol/L (400mg/dl);
• Intracranial aneurysm, arteriovenous malformation, or space-occupying brain tumor with mass effect on imaging
• Active systemic infectious disease
• Anticipated inability to complete follow-up
• Intraoperative DSA showed vascular perforation, dissection, and contrast extravasation;
• Puncture to recanalization was more than 90 minutes; Total thrombectomy passes \>3

Sponsors & Collaborators

• Tang-Du Hospital: lead
• The First people's hospital of Xian Yang: collaborator
• First People's Hospital Of Tianshui: collaborator
• XD Group Hospital: collaborator
• Xi'an Aerospace General Hospital: collaborator
• First Affiliated Hospital of Chengdu Medical College: collaborator

Study Sites (1)

Tangdu Hospital

Xi'an, Shaanxi, 710038, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Wei Guo, MD

CONTACT

0086-18729985168; 18729985168@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: August 19, 2025
• First Posted: August 26, 2025
• Study Start: August 8, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Related papers published five years later, the IPD will be shared on ResMan.

Locations

CN (1)