Injecting methylprednisolone into the artery right after clot removal for large-vessel stroke

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

This trial will test whether giving methylprednisolone into the artery immediately after successful clot removal, followed by three days of IV methylprednisolone, helps adults with anterior large-vessel occlusion strokes recover better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Tang-Du Hospital (Academic / other)
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT07516522 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled phase 2 trial enrolls adults with anterior circulation large-vessel occlusion stroke who achieve successful endovascular thrombectomy (eTICI 2b-3) within 24 hours of last known well. After randomization 1:1, patients receive either intra-arterial methylprednisolone 40 mg immediately after recanalization followed by IV methylprednisolone 2 mg/kg daily for three days, or matching placebo. Key exclusions include intracranial hemorrhage, prestroke disability (mRS ≥2), pregnancy or lactation, allergy to iodinated contrast or methylprednisolone, coagulopathy or anticoagulation use, and concurrent participation in other interventional research. The trial tests safety and whether early adjunctive intra-arterial plus intravenous steroid reduces reperfusion injury and improves neurological and functional outcomes.

Who should consider this trial

Good fit: Adults 18–80 years old with anterior circulation large-vessel occlusion (ICA, M1 or M2), NIHSS ≥6, ASPECTS ≥3 who achieve successful recanalization (eTICI 2b–3) within 24 hours are the intended participants.

Not a fit: Patients with intracranial hemorrhage, significant prestroke disability (mRS ≥2), ongoing anticoagulation, pregnancy/lactation, or allergy to steroids/contrast are unlikely to benefit or will be excluded.

Why it matters

Potential benefit: If successful, this approach could reduce reperfusion-related brain injury and improve functional recovery after thrombectomy.

How similar studies have performed: This intra-arterial steroid approach after thrombectomy is relatively novel with limited prior evidence, and systemic steroids historically have not shown clear benefit in acute ischemic stroke.

Eligibility criteria

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

Where this trial is running

Xi'an, Shaanxi

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

Study contacts

• Principal investigator: Yan Qu, MD — Tang-Du Hospital
• Study coordinator: Wei Guo, MD

Conditions Ischemia Stroke; Thrombectomy; Large Vessel Occlusion