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

Not Applicable

Recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: The methylprednisolone sodium succinate; Drug: Placebo

• Registration Number: NCT07141303
• Lead Sponsor: Tang-Du Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-08-08
• Study First Submitted: 2025-08-19
• Study First Submitted QC: 2025-08-25
• Study First Posted: 2025-08-26
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-12
• Last Update Posted: 2025-09-18
• Primary Completion: 2027-12-31
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1060

Inclusion Criteria

1. 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The methylprednisolone sodium succinate group	The methylprednisolone sodium succinate	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	Placebo	-

Primary Outcome Measures

Name	Time	Method
Shift in the distribution of mRS scores	90 days
Incidence of symptomatic intracranial hemorrhage	48 hours
Mortality	90 days

Secondary Outcome Measures

Name	Time	Method
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
Changes of NIHSS score	5-7 days after surgery
EQ-5D scale score	1 year
Proportion of patients with any radiologic intracranial haemorrhage	within 48 hours after treatment
Proportion of patients with pneumonia	within 7 days after the treatment
Proportion of patients with gastrointestinal haemorrhage	within 7 days after treatment
Incidence of non-hemorrhagic serious adverse events	within 7 days after treatment

Trial Locations

Locations (1)

Tangdu Hospital; 🇨🇳 Xi'an, Shaanxi, China