Back to resultsPaediatric Arteriopathy Steroid Aspirin Project (PASTA)
Primary Purpose
Arterial Ischemic Stroke
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Methylprednisolone + prednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Arterial Ischemic Stroke focused on measuring arterial ischemic stroke, children, steroids, aspirin, Methylprednisolone, Prednisolone
Eligibility Criteria
Inclusion Criteria:
-- Aged 6 months to <15 years
AIS ≤ 48 hours
- Newly acquired focal neurological deficit with confirmation by magnetic resonance imaging (MRI) of ischaemic lesion in an arterial territory corresponding with the clinical features (definition of Arterial ischemic stroke).
- Magnetic resonance arteriography showing unilateral proximal stenosis or irregularities of the corresponding carotid trifurcation (i.e. terminal carotid and/or M1-M2 and/or A1 segments) or of the posterior circulation (P1-P2 segments).
- 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 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 need other 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 the central nervous system with two out of the following three criteria : Children with progressive neurocognitive dysfunction; Children with bilateral lesions/vessel involvement; Children with distal arterial stenosis (beyond the M2, A1 or P2 segment).
- Children already on steroid treatment at disease onset or with a contraindication to receive 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 behavioral disorders, Current vaccination with live or attenuated live strains, Allergy/sensibility to any ingredient, Association with some medications such as antiarrhythmic drugs.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
experimental group
control group
Arm Description
Children will be treated by methylprednisolone + prednisolone and standard of care
Children will be treated by standard of care alone
Outcomes
Primary Outcome Measures
Time to recovery up to 12 months
Evaluate of time to recovery up to 12 months by score paediatric Recurrence and Recovery Questionnaire (RRQ )
Secondary Outcome Measures
Improvement of functional outcome by face-to-face visits
Evaluate of Improvement of functional outcome by face-to-face visits by score Paediatric Stroke Outcome Measure (PSOM), modified Rankin Scale (mRS) and Vineland Adaptive Behaviour Scale (VABS).
Arteriopathic course along time
Evaluate of Arteriopathic course along time by comparison between magnetic resonance (MR) arteriography and initial imaging.
Recurrence of stroke, epilepsy, neurological and developmental sequels, and academic achievement
Evaluate recurrence of stroke, epilepsy, neurological and developmental sequels, and academic achievement at 6, 12, 24 and 36 months. Neurological outcome will be assessed by standard clinical examination: motricity, sensibility, coordination, oculomotricity and visual field, cranial nerves…
Outcome by age group
Evaluate outcome by age group. All endpoints will be stratified for the whole cohort by the following age group: 0.5-3 years; 3-6 years; 6-10 years and ≥10 years. This will be done in a centrally-manner at Clinical Trials Unit (CTU) Bern.
Familial impact
Evaluate of familial impact by Alberta Perinatal Stroke Parental Outcome Measure (APSOM) and indepth interview through semi-structured interviews. The objective is to report the lived experience of parents whose child was included in the study.
Number of serious adverse events
Analysis of number of serious adverse events and their cause, consequence.
Full Information
NCT ID
NCT03249844
First Posted
August 10, 2017
Last Updated
October 17, 2022
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Ministry of Health, France
1. Study Identification
Unique Protocol Identification Number
NCT03249844
Brief Title
Paediatric Arteriopathy Steroid Aspirin Project
Acronym
PASTA
Official Title
High Dose Steroids in Children With Stroke and Unilateral Focal Arteriopathy: Paediatric Arteriopathy Steroid Aspirin (PASTA) Project. A Multicentre Randomized Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
discontinuation of the trial
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Ministry of Health, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Ischemic Stroke
Keywords
arterial ischemic stroke, children, steroids, aspirin, Methylprednisolone, Prednisolone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The outcome assessor don't know patient treatment
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
Children will be treated by methylprednisolone + prednisolone and standard of care
Arm Title
control group
Arm Type
No Intervention
Arm Description
Children will be treated by standard of care alone
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone + prednisolone
Intervention Description
The experimental intervention consists of 5 consecutive days Methylprednisolone at a daily single intravenous dose of 20 mg/kg body-weight (max 1 g/day) followed by a 4-week course of tapering Prednisolone given at a daily single oral dose in the morning:
week 1 and 2, oral Prednisolone 1 mg/kg/day (max 40 mg/day), ,
week 3 and 4, oral Prednisolone 0,5 mg/kg/day (max 20 mg/day),
Primary Outcome Measure Information:
Title
Time to recovery up to 12 months
Description
Evaluate of time to recovery up to 12 months by score paediatric Recurrence and Recovery Questionnaire (RRQ )
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Improvement of functional outcome by face-to-face visits
Description
Evaluate of Improvement of functional outcome by face-to-face visits by score Paediatric Stroke Outcome Measure (PSOM), modified Rankin Scale (mRS) and Vineland Adaptive Behaviour Scale (VABS).
Time Frame
Months:1,6,12, 24 and 36
Title
Arteriopathic course along time
Description
Evaluate of Arteriopathic course along time by comparison between magnetic resonance (MR) arteriography and initial imaging.
Time Frame
Months: 1, 6, 24
Title
Recurrence of stroke, epilepsy, neurological and developmental sequels, and academic achievement
Description
Evaluate recurrence of stroke, epilepsy, neurological and developmental sequels, and academic achievement at 6, 12, 24 and 36 months. Neurological outcome will be assessed by standard clinical examination: motricity, sensibility, coordination, oculomotricity and visual field, cranial nerves…
Time Frame
Months: 1, 3, 6,12, 24 and 36
Title
Outcome by age group
Description
Evaluate outcome by age group. All endpoints will be stratified for the whole cohort by the following age group: 0.5-3 years; 3-6 years; 6-10 years and ≥10 years. This will be done in a centrally-manner at Clinical Trials Unit (CTU) Bern.
Time Frame
Months 72
Title
Familial impact
Description
Evaluate of familial impact by Alberta Perinatal Stroke Parental Outcome Measure (APSOM) and indepth interview through semi-structured interviews. The objective is to report the lived experience of parents whose child was included in the study.
Time Frame
Months 72
Title
Number of serious adverse events
Description
Analysis of number of serious adverse events and their cause, consequence.
Time Frame
Months 72
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-- Aged 6 months to <15 years
AIS ≤ 48 hours
Newly acquired focal neurological deficit with confirmation by magnetic resonance imaging (MRI) of ischaemic lesion in an arterial territory corresponding with the clinical features (definition of Arterial ischemic stroke).
Magnetic resonance arteriography showing unilateral proximal stenosis or irregularities of the corresponding carotid trifurcation (i.e. terminal carotid and/or M1-M2 and/or A1 segments) or of the posterior circulation (P1-P2 segments).
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 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 need other 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 the central nervous system with two out of the following three criteria : Children with progressive neurocognitive dysfunction; Children with bilateral lesions/vessel involvement; Children with distal arterial stenosis (beyond the M2, A1 or P2 segment).
- Children already on steroid treatment at disease onset or with a contraindication to receive 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 behavioral disorders, Current vaccination with live or attenuated live strains, Allergy/sensibility to any ingredient, Association with some medications such as antiarrhythmic drugs.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane CHABRIER, MD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Paediatric Arteriopathy Steroid Aspirin Project
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