Methylprednisolone given into the artery and IV after thrombectomy for anterior 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

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.

Why it matters

Who can join: the full rules

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 it's running

• Tangdu Hospital
  Xi'an, Shaanxi, China Recruiting

Study contacts

• 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.

• Short-Term outside-in nerve stimulation for acute ischemic stroke

  This trial tests whether a 5-day external trigeminal nerve stimulation given after stroke can help more patients recover better than a sham treatment.

  Recruiting Xidian University · Xi'an · NCT07911605

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

  This study tests whether sevoflurane or propofol used for anesthesia during endovascular treatment of an acute ischemic stroke affects the final brain damage and recovery.

  Recruiting Phase 3 Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Barcelona · NCT07902791

• Safety of adding NRICM301 to standard care for adults with acute ischemic stroke

  This study tests whether adding NRICM301, a traditional Chinese medicine formula, to usual care is safe for adults with acute ischemic stroke.

  Recruiting En Chu Kong Hospital · New Taipei City · NCT07900503

• Intracranial Recanalization with LT3001 in Acute Ischemic Stroke

  This phase II study tests whether LT3001 given to adults with acute ischemic stroke can help reopen blocked brain arteries.

  Recruiting Phase 2 Lumosa Therapeutics Co., Ltd. · Taichung · NCT07890298

• Mobilisation After Endovascular Stroke Treatment

  This study checks whether moving around 12 hours after endovascular stroke treatment is as safe as moving around 24 hours for people with an acute ischemic stroke.

  Recruiting at 2 sites Karolinska Institutet · Tampere and 1 other locations · NCT07860333

• Endovascular therapy plus standard care vs standard care alone for distal and medium vessel strokes

  In people with acute ischemic stroke due to distal or medium vessel blockages, this study tests whether adding endovascular treatment to the usual medical care helps improve outcomes compared with medical care alone.

  Recruiting Hospital Universitari Vall d'Hebron Research Institute · Barcelona, Barcelona · NCT07843797

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.