NCT06360458

Methylprednisolone Adjunctive to Endovascular Thrombectomy for Stroke

Methylprednisolone as Adjunct to Endovascular Thrombectomy for Patients With Acute Ischemic Strokes With Large Infarct: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial (MIRACLE)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 928 (actual)
• Sponsor: Wan-Jin Chen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The efficacy and safety of methylprednisolone in acute ischemic stroke patients with large infarct cores (ASPECTS score \< 6 or infarct volume ≥50 mL) due to anterior circulation large vessel occlusion have not been clearly established. This is a multi-center, randomized, double-blind, placebo-controlled trial to investigate early combination therapy with methylprednisolone for reperfusion in acute large core infarction.

Conditions

• Acute Ischemic Stroke
• Large Infarct Core

Interventions

Type	Name	Description
DRUG	Methylprednisolone sodium succinate	Intravenous injection of methylprednisolone sodium succinate (Chongqing Lummy Pharmaceutical Co., Ltd., 40mg/bottle) with a dose of 2mg/kg (maximum dose of 160mg), once daily, for three consecutive days. The initial study drug will be administered as soon as possible after randomization. It is recommended that the initial study drug administrated before arterial access closure, but it should not be delayed more than 2 hours after arterial access closure.
DRUG	Placebo	Intravenous injection of placebo (Chongqing Lummy Pharmaceutical Co., Ltd., 40mg/bottle) with a dose of 2mg/kg (maximum dose of 160mg), once daily, for three consecutive days. The initial study drug will be administered as soon as possible after randomization. It is recommended that the initial study drug administrated before arterial access closure, but it should not be delayed more than 2 hours after arterial access closure.

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-09-30
• Completion: 2030-06-30
• First posted: 2024-04-11
• Last updated: 2025-12-03

Locations

99 sites across 1 country: China