Actively Recruiting
Methylprednisolone for Stroke With Large Infarct Core and Post-stroke Lymphocytopenia
Led by YiLin · Updated on 2025-10-01
200
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The efficacy and safety of early adjunctive methylprednisolone therapy in acute ischemic stroke patients with large infarct cores (ASPECTS score \< 6) and post-stroke lymphocytopenia remain unclear. These immunocompromised patients face higher mortality rates and poorer clinical outcomes, with limited effective treatment options currently available. This multicenter, randomized, double-blind, placebo-controlled, non-inferiority trial aims to demonstrate that early methylprednisolone administration combined with reperfusion therapy is non-inferior to placebo in terms of survival and functional outcomes at 90 days.
CONDITIONS
Official Title
Methylprednisolone for Stroke With Large Infarct Core and Post-stroke Lymphocytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age �3E= 18 years
- Time from last known well to randomization within 24 hours
- Preliminary diagnosis of anterior circulation ischemic stroke based on symptoms or imaging
- Confirmed occlusion of the intracranial internal carotid artery or M1/M2 segment of middle cerebral artery by CTA, MRA, or DSA
- Baseline NIH Stroke Scale score �3E= 6
- Baseline ASPECTS score < 6 or core infarct volume �3E= 50 ml based on imaging
- Planned treatment with endovascular thrombectomy
- Baseline peripheral blood lymphocyte count < 0.8 x 10^9/L
- Informed consent obtained from patient or legal representative
You will not qualify if you...
- Intracranial hemorrhage confirmed by CT or MRI
- Modified Rankin Scale score > 2 before the stroke
- Pregnant or breastfeeding women
- Allergy to contrast agents or glucocorticoids
- Participation in other clinical trials
- Artery tortuosity preventing thrombectomy device access
- History of gastrointestinal or urinary tract bleeding within the last month
- Chronic hemodialysis or severe kidney failure (GFR < 30 ml/min or serum creatinine > 220 umol/L)
- Life expectancy less than 6 months due to advanced disease
- Inability to complete follow-up
- Presence of intracranial aneurysm or arteriovenous malformation
- Brain tumors causing mass effect on imaging
- Systemic infectious disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Neurology, the First Affiliated Hospital Fujian Medical University
Fuzhou, Fujian, China, 350005
Actively Recruiting
Research Team
Y
Yi Lin, MD
CONTACT
Y
Ying Fu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here