Intra-arterial Methylprednisolone After Endovascular Thrombectomy (IMPACT-LVO)

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

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 = 178 patients (n=89 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 15% non-adherence rate (due to loss to follow-up, consent withdrawal and other reasons), we planned to enrol n=210 patients (n=105 per group) for this study. The findings of IMPACT-LVO are likely to have a direct impact on clinical practice.

Study Overview

• Status: Recruiting
• Conditions: Large Vessel Occlusion; Thrombectomy; Ischemia Stroke
• Intervention / Treatment: Drug: The methylprednisolone sodium succinate group; Drug: The placebo group

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Wei Guo, MD; Phone Number: 0086-18729985168; Email: 18729985168@163.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710038
      • Recruiting
      • Tangdu Hospital
      • Contact: Wei Guo, MD; Phone Number: 0086-18729985168; Email: 18729985168@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18-80 years old;
• The time from onset to randomization was within 24 hours;
• 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;
• NIHSS score >= 6 points
• Alberta Stroke Program Early Diagnosis (ASPECTS) score of NCCT >=3;
• Successful endovascular thrombectomy (eTICI 2b50-3)
• Written informed consent signed by patients or their family members

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The methylprednisolone sodium succinate 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.	Drug: The methylprednisolone sodium succinate group; Intra-arterial methylprednisolone sodium succinate 40mg immediately after the recanalization. Then, intravenous administration with methylprednisolone sodium succinate 2mg/kg in the next 3 days.
Placebo Comparator: The placebo group; The placebo group patients will receive intra-arterial and intravenous sterile water for injection.	Drug: The placebo group; The placebo group patients will receive intra-arterial and intravenous sterile water for injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality	90 days
Incidence of symptomatic intracranial hemorrhage	Incidence of symptomatic intracranial hemorrhage	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shift in the distribution of mRS scores	Shift in the distribution of mRS scores	90 days
Proportion of patients with any radiologic intracranial haemorrhage within 48 hours after treatment	Proportion of patients with any radiologic intracranial haemorrhage within 48 hours after treatment	within 48 hours after treatment
Proportion of patients with pneumonia within 7 days after EVT	Proportion of patients with pneumonia within 7 days after EVT	within 7 days after EVT
Proportion of patients with gastrointestinal haemorrhage within 7 days after EVT;	Proportion of patients with gastrointestinal haemorrhage within 7 days after EVT;	within 7 days after EVT;
Incidence of serious adverse events within 7 days after EVT.	Incidence of serious adverse events within 7 days after EVT.	within 7 days after EVT.
The proportion of mRS score 0 to 4 at 90 days	The proportion of mRS score 0 to 4 at 90 days	at 90 days
The proportion of mRS score 0 to 3 at 90 days	The proportion of mRS score 0 to 3 at 90 days	at 90 days
The proportion of mRS score 0 to 2 at 90 days	The proportion of mRS score 0 to 2 at 90 days	at 90 days
The incidence of malignant brain edema within 48 hours	The incidence of malignant brain edema within 48 hours	within 48 hours
EQ-5D scale score at 90 days	EQ-5D scale score at 90 days	at 90 days

Collaborators and Investigators

• Sponsor: Tang-Du Hospital
• Investigators: Principal Investigator: Yan Qu, MD, Tang-Du Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 22, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: K202602-29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No