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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Tangdu Hospital
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Principal investigator: Yan Qu, MD — Tang-Du Hospital
• Study coordinator: Wei Guo, MD
• Email: 18729985168@163.com
• Phone: 0086-18729985168

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Sivelestat added to endovascular clot retrieval for acute anterior circulation stroke

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• Sevoflurane vs. Propofol for anesthesia in stroke patients undergoing clot-removal

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• Tenecteplase or Reteplase Bridging Before Thrombectomy in Acute Ischemic Stroke

  This trial tests whether giving tenecteplase or reteplase before mechanical thrombectomy helps people with acute ischemic stroke due to large vessel occlusion, compared with doing thrombectomy alone.

  Recruiting Phase 3 Beijing Tiantan Hospital · Beijing, Beijing Municipality and 4 other locations · NCT07748039

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.