Focal Cerebral Arteriopathy Steroid Trial

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.

Conditions

• Pediatric Stroke
• Arteriopathy
• Arterial Ischemic Stroke

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.

Sponsors & Collaborators

• University of Cincinnati

  collaborator OTHER

• Medical University of South Carolina

  collaborator OTHER

• M.D. Anderson Cancer Center

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• University of Iowa

  collaborator OTHER

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• American Heart Association

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Heather J Fullerton, MD, MAS · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-01

Primary Completion

2029-07-31

Completion

2030-01-31

FDA Drug

Yes

Countries

• United States

Study Locations