Last updated: October 17, 2022
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Overall Status: Trial Not Available
Phase
3
Condition
Stroke
Thrombosis
Cerebral Ischemia
Treatment
N/AClinical Study ID
NCT03249844
1608184
2017-002247-15
Ages 6-15 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
-- Aged 6 months to <15 years
- AIS ≤ 48 hours
- Newly acquired focal neurological deficit with confirmation by magnetic resonanceimaging (MRI) of ischaemic lesion in an arterial territory corresponding with theclinical features (definition of Arterial ischemic stroke).
- Magnetic resonance arteriography showing unilateral proximal stenosis orirregularities of the corresponding carotid trifurcation (i.e. terminal carotidand/or M1-M2 and/or A1 segments) or of the posterior circulation (P1-P2segments).
- No evidence of an underlying systemic disorder (e.g. lupus erythematodes)explaining the features.
- Informed and signed consent of parents or legal guardians.
- French Social Security (Sécurité sociale; i.e. national health coverage) affiliation
Exclusion
Exclusion Criteria:
- Children with secondary central nervous system angiitis due to infections (meningitis,endocarditis, borreliosis), rheumatic or other systemic inflammatory diseases (e.g.lupus erythematodes). These children are already under immune suppression or needother co-medications regarding their underlying disease.
- Children with known syndromal and/or genetic vasculopathies such as phaces syndrome,Neurofibromatosis type 1, trisomy 21.
- Children with moyamoya or sickle cell disease.
- Children with a progressive large to medium vessel childhood primary angiitis of thecentral nervous system with two out of the following three criteria : Children withprogressive neurocognitive dysfunction; Children with bilateral lesions/vesselinvolvement; Children with distal arterial stenosis (beyond the M2, A1 or P2 segment).
- Children already on steroid treatment at disease onset or with a contraindication toreceive steroid treatment (e.g. congenital or acquired immunodeficiency).
- Children with delayed diagnosis ≥3 days as treatment start is not allowed to be more ≥5 day-delayed.
- Contraindications to steroids (see also summary of product characteristics in chapter 1.1) and notably: Not-manageable infectious, hydro-electrolytic or metabolic (e.g.diabetes mellitus) disorders, or elevated blood pressure, Serious behavioraldisorders, Current vaccination with live or attenuated live strains,Allergy/sensibility to any ingredient, Association with some medications such asantiarrhythmic drugs.
Study Design
Study Start date:
September 01, 2022
Estimated Completion Date:
December 31, 2027
Connect with a study center
CHU Angers
Angers, 49100
FranceSite Not Available
CHU Lyon - Hôpital Femme Mère Enfant
Bron, 69677
FranceSite Not Available
APHP - Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
FranceSite Not Available
APHP - Hôpital Necker-Enfants malades
Paris, 75015
FranceSite Not Available
Chu Saint-Etienne
Saint-Étienne, 42055
FranceSite Not Available
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