drugset / Trial / NCT06040255
Focal Cerebral Arteriopathy Steroid Trial
Phase 4
Enrolling by invitation
80 enrolled
University of California, San Francisco
American Heart Association · collabM.D. Anderson Cancer Center · collabMedical University of South Carolina · collabNational Institute of Neurological Disorders and Stroke (NINDS) · collabUniversity of Cincinnati · collabUniversity of Colorado, Denver · collabUniversity of Iowa · collab
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2023-10-01
- Primary completion
- 2029-07-31
- Completion
- 2030-01-31
Publications
- Background Wintermark M, Hills NK, DeVeber GA, Barkovich AJ, Bernard TJ, Friedman NR, Mackay MT, Kirton A, Zhu G, Leiva-Salinas C, Hou Q, Fullerton HJ; VIPS Investigators. Clinical and Imaging Characteristics of Arteriopathy Subtypes in Children with Arterial Ischemic Stroke: Results of the VIPS Study. AJNR Am J Neuroradiol. 2017 Nov;38(11):2172-2179. doi: 10.3174/ajnr.A5376. Epub 2017 Oct 5.
- Background Fullerton HJ, Stence N, Hills NK, Jiang B, Amlie-Lefond C, Bernard TJ, Friedman NR, Ichord R, Mackay MT, Rafay MF, Chabrier S, Steinlin M, Elkind MSV, deVeber GA, Wintermark M; VIPS Investigators. Focal Cerebral Arteriopathy of Childhood: Novel Severity Score and Natural History. Stroke. 2018 Nov;49(11):2590-2596. doi: 10.1161/STROKEAHA.118.021556.
- Background Elkind MS, Hills NK, Glaser CA, Lo WD, Amlie-Lefond C, Dlamini N, Kneen R, Hod EA, Wintermark M, deVeber GA, Fullerton HJ; VIPS Investigators*. Herpesvirus Infections and Childhood Arterial Ischemic Stroke: Results of the VIPS Study. Circulation. 2016 Feb 23;133(8):732-41. doi: 10.1161/CIRCULATIONAHA.115.018595. Epub 2016 Jan 26.
- Background Steinlin M, Bigi S, Stojanovski B, Gajera J, Regenyi M, El-Koussy M, Mackay MT; Swiss NeuroPediatric Stroke Registry. Focal Cerebral Arteriopathy: Do Steroids Improve Outcome? Stroke. 2017 Sep;48(9):2375-2382. doi: 10.1161/STROKEAHA.117.016818. Epub 2017 Jul 21.
- Background Steinlin M, O'callaghan F, Mackay MT. Planning interventional trials in childhood arterial ischaemic stroke using a Delphi consensus process. Dev Med Child Neurol. 2017 Jul;59(7):713-718. doi: 10.1111/dmcn.13393. Epub 2017 Jan 25.
- Background Fullerton HJ, Hills NK, Elkind MS, Dowling MM, Wintermark M, Glaser CA, Tan M, Rivkin MJ, Titomanlio L, Barkovich AJ, deVeber GA; VIPS Investigators. Infection, vaccination, and childhood arterial ischemic stroke: Results of the VIPS study. Neurology. 2015 Oct 27;85(17):1459-66. doi: 10.1212/WNL.0000000000002065. Epub 2015 Sep 30.
- Background Lanthier S, Armstrong D, Domi T, deVeber G. Post-varicella arteriopathy of childhood: natural history of vascular stenosis. Neurology. 2005 Feb 22;64(4):660-3. doi: 10.1212/01.WNL.0000151851.66154.27.
- Background Chabrier S, Rodesch G, Lasjaunias P, Tardieu M, Landrieu P, Sebire G. Transient cerebral arteriopathy: a disorder recognized by serial angiograms in children with stroke. J Child Neurol. 1998 Jan;13(1):27-32. doi: 10.1177/088307389801300105.
- Background Braun KP, Bulder MM, Chabrier S, Kirkham FJ, Uiterwaal CS, Tardieu M, Sebire G. The course and outcome of unilateral intracranial arteriopathy in 79 children with ischaemic stroke. Brain. 2009 Feb;132(Pt 2):544-57. doi: 10.1093/brain/awn313. Epub 2008 Nov 27.
- Background Slavova N, Fullerton HJ, Hills NK, Breiding PS, Mackay MT, Steinlin M. Validation of the focal cerebral arteriopathy severity score (FCASS) in a Swiss cohort: Correlation with infarct volume and outcome. Eur J Paediatr Neurol. 2020 Sep;28:58-63. doi: 10.1016/j.ejpn.2020.07.015. Epub 2020 Aug 4.
- Background Lo WD, Ichord RN, Dowling MM, Rafay M, Templeton J, Halperin A, Smith SE, Licht DJ, Moharir M, Askalan R, Deveber G; International Pediatric Stroke Study (IPSS) Investigators. The Pediatric Stroke Recurrence and Recovery Questionnaire: validation in a prospective cohort. Neurology. 2012 Aug 28;79(9):864-70. doi: 10.1212/WNL.0b013e318266fc9a. Epub 2012 Aug 15.
- Background Schechter T, Kirton A, Laughlin S, Pontigon AM, Finkelstein Y, MacGregor D, Chan A, deVeber G, Brandao LR. Safety of anticoagulants in children with arterial ischemic stroke. Blood. 2012 Jan 26;119(4):949-56. doi: 10.1182/blood-2011-06-361535. Epub 2011 Dec 7.
- Fullerton HJ, Hills NK, Chen H, Dlamini N, Stence NV, Wintermark M; VIPS II Investigators. Changing Management of Focal Cerebral Arteriopathy of Childhood From 2010 to 2022. Stroke. 2025 Jun;56(6):1460-1468. doi: 10.1161/STROKEAHA.124.050550. Epub 2025 May 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Methylprednisolone | Other / unclassified | — | — |
| Comparator | Prednisolone | Other / unclassified | — | — |
| Comparator | Prednisone | Other / unclassified | — | — |