PASTA (Paediatric Arteriopathy Steroid Aspirin) trial, V3
Research type
Research Study
Full title
High Dose Steroids in Children with Stroke and Unilateral Focal Arteriopathy: A Multicentre Randomized Controlled Trial PASTA (Paediatric Arteriopathy Steroid Aspirin) trial
IRAS ID
305395
Contact name
Finbar O'Callaghan
Contact email
Sponsor organisation
University Childrens Hopital, Inselspital, Bern
Eudract number
2021-005571-39
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 8 months, 0 days
Research summary
Background
Arterial Ischaemic Stroke (AIS) is a rare but devastating condition affecting 2-5/100,000 children/year. Two-thirds of surviving children suffer long term neurological, cognitive and behavioural problems. The economic cost is substantial.
Arteriopathy is identified as the underlying cause of AIS in 60-80% of cases and is the strongest predictor of recurrence. 30-40% of these children will have a Focal Cerebral Arteriopathy (FCA). FCA in childhood is characterised by inflammation of one of the arteries in the brain that has been provoked by a previous infection (e.g. chicken pox). This disease mechanism suggests that treatment with steroids, which are often used in inflammatory conditions, may be an effective treatment but there is a lack of evidence supporting this approach. Currently, these children are treated with a course of low dose aspirin which is an antithrombotic agent.
Study Design
This study will be the first randomized clinical trial in children in the UK with arterial ischaemic stroke. Patients aged between 6 months up to 16 years of age who have had a stroke due to FCA will be randomised to receive conventional treatment (antithrombotic treatment i.e. aspirin) or combination treatment (aspirin + steroids). The patients will then be followed up at regular intervals over one year to determine the radiological outcome (i.e. whether the inflammation of the artery involved has resolved or not), the degree of recovery and residual disability, the cognitive and psychological outcome and the incidence of recurrent strokes. The study aims to recruit 70 children in total over a three year period across sites in Switzerland, France, Australia, Germany, Austria and the UK. The study will involve one additional MRI scan over and above usual clinical practice and the administration of questionnaires to the family and child at 30, 90, 180 and 360 days after discharge from hospital.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
22/WM/0068
Date of REC Opinion
19 Apr 2022
REC opinion
Further Information Favourable Opinion