An interventional study of Methylprednisolone sodium succinate and Placebo in Ischemic Stroke, Acute, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-09-16.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Not applicable, Interventional, and Treatment
It is uncertain whether intravenous methylprednisolone improves outcomes for acute anterior circulation large vessel occlusion (LVO) patients with a large infarct core. In this study, the investigators hypothesize that methylprednisolone plus endovascular thrombectomy (EVT) might be superior to EVT alone in patients with evidence of a large infarct volume. The primary objective of the study is to establish the efficacy of methylprednisolone with EVT in patients with acute anterior circulation LVO and a large infarct core.
The PEARL-MERIT is a multicenter, prospective, randomized, double-blind, placebo-controlled trial. A total of 912 patients (aged 18-85 years) within 24 hours of symptom onset of acute ischemic stroke, who have imaging evidence of an occlusion of the intracranial internal carotid artery (ICA) and/or M1/M2 segment of middle cerebral artery (MCA), a large infarct core, and a planned EVT, will be enrolled.
Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into 2 groups after obtaining informed consent. One group will receive methylprednisolone, the other group will receive placebo. The primary objective is to evaluate the efficacy of methylprednisolone with EVT compared to placebo with EVT in patients with acute ischemic stroke due to anterior circulation LVO and a large infarct core.
2,593 studies on the registry are indexed under Ischemic Stroke; 931 are open to participants now.
This study's planned enrollment of 912 is above the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 466 studies on the registry; 271 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Methylprednisolone sodium succinate
Drug: Placebo
Intravenous methylprednisolone sodium succinate will be administered at a dose of 2 mg/kg/day for 3 days, with a maximum daily dose of 160 mg (4 vials, 40 mg/vial). It is recommended that the initial dose be administered as soon as possible after randomization.
Also known as: Methylprednisolone
Matched intravenous placebo will be administered for 3 days, with a maximum daily dose of 4 vials.
The modified Rankin Scale score (mRS) 0-3
The proportion of mRS score 0-3 at 90 (±14) days
Time frame: 90±14 days after randomization
The distribution of the modified Rankin Scale scores
The shift analysis of mRS at 90±14 days (merged 0-1)
Time frame: 90±14 days after randomization
The modified Rankin Scale score (mRS) 0-4
The proportion of mRS score 0-4 at 90 (±14) days
Time frame: 90±14 days after randomization
The modified Rankin Scale score (mRS) 0-2
The proportion of mRS score 0-2 at 90 (±14) days
Time frame: 90±14 days after randomization
The modified Rankin Scale score (mRS) 0-1
The proportion of mRS score 0-1 at 90 (±14) days
Time frame: 90±14 days after randomization
Quality of Life (EQ-5D-5L)
Quality of life measured by EQ-5D-5L scale score at 90 (±14) days
Time frame: 90±14 days after randomization
Neurologic deficit (NIHSS score) changes
National Institutes of Health Stroke Scale (NIHSS) score change from baseline, at 7 (±1) days or at discharge
Time frame: 7±1 days after randomization/at discharge
Infarct core volume changes
Infarct core volume change from baseline, assessed with NCCT at 7±1 days after randomization/at discharge or with MRI at 36±12 hours
Time frame: 7±1 days after randomization/at discharge or at 36±12 hours after randomization
Rate of decompressive craniectomy
Rate of decompressive craniectomy at 7 (±1) days
Time frame: 7±1 days after randomization
SAFETY OUTCOME: Mortality
All-cause mortality within 90 days
Time frame: 90±14 days after randomization
SAFETY OUTCOME: Symptomatic intracranial hemorrhage (sICH)
Symptomatic intracranial hemorrhage (sICH) within 48 hours (according to Heidelberg criteria)
Time frame: Within 48 hours after randomization
SAFETY OUTCOME: Any serious adverse events and steroid-related adverse events (hyperglycemia, infection, and gastrointestinal hemorrhage)
Safety will be assessed according to common terminology criteria for adverse events (CTCAE)
Time frame: 90±14 days after randomization
Plan to share: No
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This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University