High Dose Steroids and Aspirin Treatment in Children With Stroke Caused by Unilateral Focal Arteriopathy An International Randomized Trial

What this Trial Is About

This trial focuses on children with focal cerebral arteriopathy FCA, a rare but serious condition that causes stroke in childhood. FCA is an inflammatory disease of the blood vessels in the brain triggered by infection. Researchers aim to find out if treating children with high dose steroids plus aspirin leads to better and faster recovery, improved clinical outcomes, and fewer stroke recurrences compared to treatment with aspirin alone. This is a phase 3, randomized controlled study conducted across multiple international centers. Participants will be randomly assigned to one of two groups one group will receive standard care including aspirin plus high dose intravenous methylprednisolone followed by oral prednisolone tapering, while the other group will receive standard care including aspirin without steroids. Steroid treatment is given intravenously for 3 days at 30 mgkgday maximum 1000 mgday, followed by oral prednisolone for 4 weeks with a tapering dose schedule. Treatment begins within 48 hours of diagnosis and no later than 96 hours after stroke onset. Children will be monitored at 1, 3, 6, and 12 months after treatment begins. Evaluations include neurological exams, MRI and MRA imaging at 1, 3 if available, and 6 months, and various outcome assessments such as stroke severity scores, functional measures, cognitive tests, and quality of life questionnaires. Researchers will track recovery, stroke recurrence, and vessel changes to assess treatment effects and safety over the study duration of 48 months.

High Dose Steroids in Children With Stroke