Methylprednisolone as Adjunct to Endovascular Thrombectomy for Acute Ischemic Stroke Patients with a Large Infarct Core (MIRACLE): Protocol of a Randomized Trial
Bibliographic record
Abstract
ABSTRACT 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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.027 | 0.022 |
| Meta-epidemiology (narrow) | 0.006 | 0.003 |
| Meta-epidemiology (broad) | 0.011 | 0.006 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.003 | 0.003 |
| Scholarly communication | 0.004 | 0.003 |
| Open science | 0.004 | 0.002 |
| Research integrity | 0.006 | 0.007 |
| Insufficient payload (model declined to judge) | 0.036 | 0.008 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".