Methylprednisolone given into the artery and IV after thrombectomy for anterior large-vessel stroke

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

This trial tests whether giving intra-arterial methylprednisolone immediately after a successful thrombectomy followed by three days of IV methylprednisolone helps people with acute anterior large-vessel ischemic stroke recover better.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1060 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Tang-Du Hospital (Academic / other)
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT07141303 on ClinicalTrials.gov

What this trial studies

IMPACT-LVO is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial enrolling anterior circulation large-vessel occlusion stroke patients within 24 hours of last known well who achieve successful reperfusion (eTICI 2b50-3) after endovascular thrombectomy. Participants are randomized 1:1 to receive either intra-arterial methylprednisolone 40 mg immediately after recanalization followed by intravenous methylprednisolone 2 mg/kg daily for three days, or matching placebo. The trial will monitor safety and functional outcomes to determine if the steroid regimen reduces secondary injury and improves recovery. Standard imaging and clinical scales (NIHSS, ASPECTS, mRS) are used for eligibility and outcome assessment under blinded conditions.

Who should consider this trial

Good fit: Adults 18–80 with anterior circulation large-vessel occlusion acute ischemic stroke within 24 hours, NIHSS ≥6, ASPECTS ≥3, who achieve successful endovascular thrombectomy (eTICI 2b50-3) and can provide informed consent are ideal candidates.

Not a fit: Patients with intracranial hemorrhage, prestroke disability (mRS ≥2), pregnancy or lactation, allergy to methylprednisolone, unsuccessful recanalization, or those outside the time window are unlikely to benefit from this trial intervention.

Why it matters

Potential benefit: If effective, this approach could reduce post-reperfusion inflammation and secondary brain injury, leading to better functional recovery and less disability after thrombectomy.

How similar studies have performed: Steroids in acute stroke have produced mixed results historically, and the specific strategy of intra-arterial steroid immediately after thrombectomy is relatively novel and not yet proven in large trials.

Eligibility criteria

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

Where this trial is running

Xi'an, Shaanxi

• Tangdu Hospital — Xi'an, Shaanxi, China (Recruiting)

Study contacts

• Study coordinator: Wei Guo, MD

Conditions Acute Ischemic Stroke