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ENROLLING BY INVITATION
NCT06040255
PHASE4

Focal Cerebral Arteriopathy Steroid Trial

Sponsor: University of California, San Francisco

View on ClinicalTrials.gov

Summary

This comparative effectiveness trial (CET) in children with suspected focal cerebral arteriopathy (FCA) presenting with arterial ischemic stroke (AIS) or transient ischemic attack (TIA) will compare the use of early corticosteroid treatment (Arm A) versus delayed/no corticosteroid treatment (Arm B). Delayed corticosteroid treatment is given only for those demonstrating disease progression and is initiated as soon as the progression is detected (at any time after randomization). All participants will also receive standard of care therapy (aspirin and supportive care). Sites will randomize participants 1:1 to Arm A or B. Participants will be enrolled and randomized as soon as possible after their stroke/TIA up until 96 hours following the initial stroke/TIA event.

Key Details

Gender

All

Age Range

1 Year - 18 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2023-10-01

Completion Date

2030-01-31

Last Updated

2026-01-26

Healthy Volunteers

No

Interventions

DRUG

methylprednisolone, prednisolone, prednisone

Any generic or brand-name methylprednisolone at the appropriate dose may be used. Likewise, any generic or brand-name prednisolone, or prednisone, at the appropriate dose may be used.

Locations (1)

University of California San Francisco

San Francisco, California, United States