Methylprednisolone as Adjunct to Endovascular Thrombectomy for Acute Ischemic Stroke Patients with a Large Infarct Core (MIRACLE): Protocol of a Randomized Trial
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Background
Despite successful endovascular thrombectomy (EVT) for acute ischemic stroke (AIS) with a large infarct core, patient disability and mortality remain high.
Aim
The MIRACLE trial aims to evaluate the efficacy and safety of administering adjunct intravenous methylprednisolone in AIS patients with a large infarct core.
Design
Methylprednisolone as Adjunct to Endovascular Thrombectomy for patients with Acute Large Ischemic Stroke (MIRACLE) is a multicenter, prospective, randomized, double-blind, placebo-controlled phase 3 trial conducted across 99 stroke centers in China. A total of 902 patients with anterior circulation large vessel occlusion and large infarct core (Alberta Stroke Program Early CT Score [ASPECTS] <6 or infarct volume ≥50 mL on CT perfusion) presenting within 12 hours of last known well time will be randomized 1:1 to receive either intravenous methylprednisolone (2 mg/kg/day, max 160 mg) or its corresponding placebo for three consecutive days, starting immediately after randomisation.
Study outcomes
The primary efficacy outcome is all-cause mortality at 90 days. Key secondary outcomes include functional status assessed by the modified Rankin Scale (mRS), neurological status assessed by National Institutes of Health Stroke Scale (NIHSS), quantitative cerebral edema markers (midline shift, relative hemispheric volume, and water uptake), and decompressive craniectomy rates. The primary safety outcome is symptomatic intracranial hemorrhage (SICH) within 48 hours post-EVT. Analyses will follow the intention-to-treat principle. Recruitment began in August 2024 and is expected to conclude by October 2025.
Conclusion
The MIRACLE trial will provide evidence of the efficacy and safety of adjunctive methylprednisolone in AIS patients with a large core undergoing EVT within 12 hours of last known well.
Trial Registration
ClinicalTrials.gov NCT06360458
CLINICAL PERSPECTIVE
What Is New?
The MARVEL trial (Methylprednisolone as Adjunct to Endovascular Thrombectomy for Large Vessel Occlusion Stroke) [1] demonstrated a potential safety benefit and reduced mortality with adjunctive methylprednisolone in patients with anterior circulation large vessel occlusion stroke undergoing endovascular thrombectomy (EVT), but it excluded patients with very large infarct core (Alberta Stroke Program Early CT Score [ASPECTS] <3 or volume >50-70 mL), leaving its efficacy in this high-risk population unknown. This study aims to investigate whether adjunctive methylprednisolone improves survival in acute ischemic stroke (AIS) patients with large infarct core undergoing EVT (ASPECTS < 6 and/or core infarct volume > 50 ml).
What Aare the Clinical Implications?
If positive, MIRACLE will provide robust evidence for a simple, accessible, and inexpensive adjunctive therapy to EVT that could improve outcomes for AIS patients with large infarct core.
