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High dose steroids for children with stroke

High Dose Steroids in Children With Stroke and Unilateral Focal Arteriopathy: A Multicentre Randomized Controlled Trial PASTA (Paediatric Arteriopathy Steroid Aspirin) Trial

Phase 3 Interventional Insel Gruppe AG, University Hospital Bern · NCT04873583

This study is testing if giving high dose steroids along with regular treatment can help children who have had a stroke feel better and prevent future strokes.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment70 (estimated)
Ages6 Months to 17 Years
SexAll
SponsorInsel Gruppe AG, University Hospital Bern Academic / other
Locations35 sites (Randwick, New South Wales and 34 other locations)
Trial IDNCT04873583 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of high dose steroids in children suffering from arterial ischemic stroke, particularly focusing on those with focal cerebral arteriopathy (FCA). Participants will be randomly assigned to receive either standard care with high dose steroids or standard care alone. The study aims to determine if the addition of steroids can improve outcomes and reduce the recurrence of strokes in this vulnerable population. Conducted across over 20 hospitals in multiple countries, this trial seeks to provide high-level evidence for the treatment of childhood stroke related to FCA.

Who should consider this trial

Good fit: Ideal candidates are children aged 6 months to 18 years who have experienced a unilateral stroke and can be randomized within 48 to 96 hours of diagnosis.

Not a fit: Patients with previous strokes, known syndromal disorders, or specific genetic vasculopathies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve recovery outcomes and reduce the risk of recurrent strokes in children with FCA.

How similar studies have performed: While this approach is novel in the context of childhood arterial ischemic stroke, retrospective analyses suggest that steroid treatment may improve outcomes in similar cases.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Informed consent of the legal representative of the trial participant documented by signature
2. Age \> 6 months \& \< 18 years at time of stroke
3. Randomisation possible within 48 hours of diagnosis and maximum 96 hours after stroke onset
4. 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)
5. Unless otherwise defined in the national addendum: Female participants age ≥ 13: Negative pregnancy test (blood or urine)

Exclusion Criteria:

1. Previous stroke
2. Known syndromal disorders, as e.g. Trisomy 21, Neurofibromatosis type 1
3. Known genetic vasculopathies as e.g. posterior fossa anomalies, hemangioma, arterial anomalies, cardiac anomalies and eye anomalies syndrome (PHACES), actin alpha 2 (ACTA II)
4. Moyamoya or sickle cell disease
5. Small vessel cerebral vasculitis (primary CNS vasculitis)
6. Bilateral arteriopathy
7. Arterial dissection(s)
8. Evidence of underlying systemic disorders, as e.g. lupus, rheumatoid problems
9. Secondary CNS angiitis due to infections (meningitis, endocarditis, borreliosis), or generalised angiitis due to rheumatic or other autoimmune problems
10. Progressive large to medium childhood primary angiitis of the CNS (cPACNS ) with 2 of the following 3 criteria:

    1. pre-existing progressive neurocognitive dysfunction
    2. bilateral MRI lesions/vessel involvement
    3. small vessel arterial stenosis
11. On steroid treatment at disease onset
12. Contraindication to steroid treatment as e.g. a congenital or acquired immunodeficiency
13. Inability to follow the procedures of the study, e.g. due to language problems
14. Participation in another interventional study within the 30 days preceding the indication stroke and during the present study

Where this trial is running

Randwick, New South Wales and 34 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Paediatric StrokeIschemicStrokePediatricSteroidsUnilateralFocalArteriopathy
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.