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Clinical Trial Summary

Arterial ischemic stroke (AIS) is a devastating condition, affecting 1.6-5/100,000 children/year. Although their outcome is different, children with stroke do not recover better than adults, with at least 2/3 suffering long term sequels such as developmental (motor, global intellectual, language...) and behavioral disabilities, epilepsy, and low adaptative and academic skills... Stenotic cerebral arteriopathy is identified as AIS etiology in 60-80% of previously healthy children and the course of this arteriopathy is the strongest predictor of recurrent events. 30-40% of these children have a focal unilateral cerebral arteriopathy (FCA). Childhood FCA is suspected to be an inflammatory vessel wall pathology triggered by varicella and other (viral) infections. As recurrences occur for the great majority in the first 6 months after the index event, aspirin 5 mg/kg/day is recommended for at least 18 months to 2 years. As there is a rational for using immunomodulatory drugs at the acute stage of FCA, immunotherapies are currently used by neuropaediatricians in AIS, mainly as steroids for children with stenosing arteriopathies. However, due to weak evidences, the literature cannot either encourage or discourage this practice. The long term course of children with FCA is only approach to date by retrospective studies and controversies about outcome remain (for example, the recurrence risk on antithrombotic treatment varies notably from quasi zero to 25%). And finally, it is shown in childhood stroke, as well as in the global field of longstanding impairment, that parental and medical points of view do not match consistently. Longitudinal studies are needed to deserve this familial approach.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT03249844
Study type Interventional
Source Centre Hospitalier Universitaire de Saint Etienne
Contact
Status Withdrawn
Phase Phase 3
Start date September 1, 2022
Completion date December 31, 2027

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT06040255 - Focal Cerebral Arteriopathy Steroid Trial Phase 4
Completed NCT04962503 - A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS) Phase 2
Completed NCT03887143 - National Retrospective Study Of Recanalization Treatments In Pediatric Arterial Ischemic Stroke