High-dose steroids with aspirin for children with stroke from arteriopathy
Tests high-dose steroids plus aspirin against aspirin alone in children with stroke from inflamed arteries.
Plain-language title generated from the registry record
Registry title: High Dose Steroids in Children With Stroke
Key facts
- Where
- Jette, BelgiumSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children who recently had a stroke caused by an inflamed blood vessel on one side of the brain (focal cerebral arteriopathy). It tests high dose steroids added to standard care with aspirin.
- Age
- Older than 6 months and younger than 18 years at the time of the stroke.
- Sex
- Boys and girls can join.
- Disease stage
- Newly acquired neurologic deficits, with narrowing or irregular blood vessels on one side only in the brain, seen on MRA imaging. Randomisation within 48 hours of diagnosis and at most 96 hours after stroke onset.
- Earlier treatment
- Children already on steroid treatment when the disease started cannot join.
Main reasons for not taking part
- A previous stroke
- Known syndromes or genetic vessel diseases, such as Trisomy 21 or Neurofibromatosis type 1
- Moyamoya or sickle cell disease, or vessel disease on both sides
- Contraindication to steroid treatment, such as an immunodeficiency
- Taking part in another interventional study in the 30 days before the stroke
Read by machine on 12 November 2026.
Where in Belgium
- UZ BrusselJette, BelgiumNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Insel Gruppe AG, University Hospital Bern
- Trial code
- NCT04873583EU 2022-500631-36-00
- Record updated
- 18 November 2025
- Original description
This clinical trial deals with focal cerebral arteriopathy and childhood stroke, a rare but devastating condition.Read full original descriptionShow less
High Dose Steroids in Children With Stroke and Unilateral Focal Arteriopathy: A Multicentre Randomized Controlled Trial PASTA (Paediatric Arteriopathy Steroid Aspirin) Trial
This clinical trial deals with focal cerebral arteriopathy and childhood stroke, a rare but devastating condition.
Focal cerebral arteriopathy (FCA) is an inflammatory vessel wall disease provoked by infection and there is increasing evidence that inflammatory processes play a crucial role in childhood stroke, influencing the outcome of the disease.
Analysis of existing data suggests that outcomes are improved and that there is less stroke recurrence in children treated with steroids to reduce the acute inflammatory processes. This clinical trial will be conducted in over 20 hospitals in several countries in order to investigate this.
Participants will be randomly separated into two groups. The first group will be treated with standard of care (including aspirin) combined with high dose steroids. The second group will be treated with standard of care (including aspirin) but without steroid treatment.
The objective is to investigate if children treated with a combination of high dose steroid and aspirin will have a better and quicker recovery of FCA, better clinical functional outcome, and less recurrence compared to children treated with aspirin alone.
This project has been identified by international pediatric stroke experts as the most important topic for a clinical trial in the field and is as well one of the most important research priorities identified by parents. The study results will also provide insight into the evolution of inflammatory vessel disease.
Inclusion: Informed consent of the legal representative of the trial participant documented by signature; Age > 6 months \& < 18 years at time of stroke; Randomisation possible within 48 hours of diagnosis and maximum 96 hours after stroke onset; Unilateral arteriopathy according to the following criteria:; Newly acquired neurologic deficits; Specific neuroimaging (MRA) features of either; unilateral stenosis, or; unilateral vessel irregularities within the Central Nervous System (CNS); Unless otherwise defined in the national addendum: Female participants age ≥ 13: Negative pregnancy test (blood or urine).
Exclusion: Previous stroke; Contraindication to steroid treatment as e.g. a congenital or acquired immunodeficiency; Known syndromal disorders, as e.g. Trisomy 21, Neurofibromatosis type 1; Known genetic vasculopathies as e.g. posterior fossa anomalies, hemangioma, arterial anomalies, cardiac anomalies and eye anomalies syndrome (PHACES), actin alpha 2 (ACTA II); Moyamoya or sickle cell disease; Evidence of underlying systemic disorders, as e.g. lupus, rheumatoid problems; Secondary CNS angiitis due to infections (meningitis, endocarditis, borreliosis), or generalised angiitis due to rheumatic or other autoimmune problems; On steroid treatment at disease onset; Participation in another interventional study within the 30 days preceding the indication stroke and during the present study; Small vessel cerebral vasculitis (primary CNS vasculitis); Bilateral arteriopathy; Arterial dissection(s); Progressive large to medium childhood primary angiitis of the CNS (cPACNS ) with 2 of the following 3 criteria:; pre-existing progressive neurocognitive dysfunction; bilateral MRI lesions/vessel involvement; small vessel arterial stenosis; Inability to follow the procedures of the study, e.g. due to language problems.