Methylprednisolone for Stroke With Large Infarct Core and Post-stroke Lymphocytopenia (MIRACLE-2)

YiLin

Status and phase

Enrolling

Phase 3

Conditions

Post-stroke Lymphocytopenia

Large Infarct Core

Treatments

Drug: Methylprednisolone sodium succinate

Drug: Normal Saline

Study type

Interventional

Funder types

Other

Identifiers

NCT07202143

MRCTA, ECFAH of FMU [2025]887

Details and patient eligibility

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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 18 years.
The time from last known well to randomization was within 24 hours.
Anterior circulation ischemic stroke was preliminarily determined according to clinical symptoms or imaging examination.
Occlusion of the intracranial internal carotid artery, the M1- or M2-segment of the middle cerebral artery by confirmed by CT angiography (CTA), MR angiography (MRA), or digital subtraction angiography (DSA).
Baseline National Institutes of Health Stroke Scale (NIHSS) ≥ 6.
Baseline Alberta Stroke Program Early CT Score (ASPECTS) < 6 (based on non-contrast CT or MRI) or core infarct volume ≥ 50 ml (based on CTP with rCBF < 30%).
Planned treatment with endovascular thrombectomy (EVT).
Baseline peripheral blood lymphocyte < 0.8×10#/L
Informed consent obtained from patients or their legal representatives.

Exclusion criteria

Intracranial hemorrhage confirmed by cranial CT or MRI.
mRS score > 2 before the time of last known well.
Pregnant or lactating women.
Allergic to contrast agents or glucocorticoids.
Participating in other clinical trials.
The artery is tortuous so that the thrombectomy device cannot reach the target vessel.
Bleeding history (gastrointestinal and urinary tract bleeding) in recent 1 month.
Chronic hemodialysis and severe renal insufficiency (glomerular filtration rate < 30 ml/min or serum creatinine > 220 umol/L [2.5 mg/ dL]).
Life expectancy due to any advanced disease < 6 months.
Follow-up is not expected to be completed.
Intracranial aneurysm and arteriovenous malformation.
Brain tumors with imaging mass effect.
Systemic infectious disease.