NCT07175649

Methylprednisolone Sodium Succinate With Endovascular ThRombectomy for Large Ischemic STroke

Methylprednisolone Sodium Succinate With Endovascular ThRombectomy for Large Ischemic STroke: A Randomized, Double-blind, Placebo-controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 912 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ischemic Stroke, Acute

Interventions

Type	Name	Description
DRUG	Methylprednisolone sodium succinate	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.
DRUG	Placebo	Matched intravenous placebo will be administered for 3 days, with a maximum daily dose of 4 vials.

Timeline

• Start date: 2025-10-01
• Primary completion: 2028-12-01
• Completion: 2029-12-01
• First posted: 2025-09-16
• Last updated: 2025-09-16

Locations

1 site across 1 country: China