Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04873583
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2021-04-15
Brief Title:
High Dose Steroids in Children With Stroke
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
High Dose Steroids in Children With Stroke and Unilateral Focal Arteriopathy A Multicentre Randomized Controlled Trial PASTA Paediatric Arteriopathy Steroid Aspirin Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PASTA
Brief Summary:
This clinical trial deals with focal cerebral arteriopathy and childhood stroke a rare but devastating condition
Focal cerebral arteriopathy FCA is an inflammatory vessel wall disease provoked by infection and there is increasing evidence that inflammatory processes play a crucial role in childhood stroke influencing the outcome of the disease
Analysis of existing data suggests that outcomes are improved and that there is less stroke recurrence in children treated with steroids to reduce the acute inflammatory processes This clinical trial will be conducted in over 20 hospitals in several countries in order to investigate this
Participants will be randomly separated into two groups The first group will be treated with standard of care including aspirin combined with high dose steroids The second group will be treated with standard of care including aspirin but without steroid treatment
The objective is to investigate if children treated with a combination of high dose steroid and aspirin will have a better and quicker recovery of FCA better clinical functional outcome and less recurrence compared to children treated with aspirin alone
This project has been identified by international pediatric stroke experts as the most important topic for a clinical trial in the field and is as well one of the most important research priorities identified by parents The study results will also provide insight into the evolution of inflammatory vessel disease
Focal cerebral arteriopathy FCA is an inflammatory vessel wall disease provoked by infection and there is increasing evidence that inflammatory processes play a crucial role in childhood stroke influencing the outcome of the disease
Analysis of existing data suggests that outcomes are improved and that there is less stroke recurrence in children treated with steroids to reduce the acute inflammatory processes This clinical trial will be conducted in over 20 hospitals in several countries in order to investigate this
Participants will be randomly separated into two groups The first group will be treated with standard of care including aspirin combined with high dose steroids The second group will be treated with standard of care including aspirin but without steroid treatment
The objective is to investigate if children treated with a combination of high dose steroid and aspirin will have a better and quicker recovery of FCA better clinical functional outcome and less recurrence compared to children treated with aspirin alone
This project has been identified by international pediatric stroke experts as the most important topic for a clinical trial in the field and is as well one of the most important research priorities identified by parents The study results will also provide insight into the evolution of inflammatory vessel disease
Detailed Description:
Background Arterial ischemic stroke AIS is a rare but devastating condition affecting 2-5100000 childrenyear Children do not recover better than adults with 23 suffering long term neurological cognitive and behavioural problems The economic cost of stroke is substantial Arteriopathy is identified as AIS aetiology in 60-80 of previously healthy children and is the strongest predictor of recurrent events 30-40 of these children will have a focal cerebral arteriopathy FCA FCA in childhood is shown to be an inflammatory vessel wall pathology provoked by infections This encourages treatment with steroids despite lack of evidence
Rationale There is increasing evidence that etiologically inflammatory processes play a crucial role in childhood stroke and influence outcome Retrospective analyses suggest improved outcome and less recurrence with steroid treatment With the exception of sickle cell disease this study will be the first randomized clinical trial in children with arterial ischemic stroke It will provide high-level evidence for the most appropriate treatment for children with AIS due to FCA Alignment of interventions and outcome as well as pooled analysis with the planned Focal Cerebral Arteriopathy Steroid FOCAS study in North America will allow pooled analysis resultsThis is very important in view of the marked neurological social and economic burden of childhood AIS for patients and families This project has been identified as the most important AIS treatment trial by a Delphi survey of international paediatric stroke experts and is one of the most important research priorities identified by parents In addition the study will provide insights into the pathogenesis of inflammatory vasculopathiesThe objective of this trial is to show that children with first stroke event due to unilateral FCA treated with a combination of high dose steroid and aspirin will have better and quicker recovery of arteriopathy better clinical functional outcome and less recurrence compared to children treated with aspirin alone
The proposed study is a prospective multicentre parallel group two-arm randomized controlled open-label clinical trial with blinded outcome assessment comparing a high dose course of methylprednisolone prednisolone plus standard of care with standard of care alone in children with unilateral arteriopathy and acute ischemic stroke
Measurements and procedures Participants will be randomized within 48 hours after diagnosis maximum 96 hours after stroke onset to standard of care SC alone control group or SC plus steroids experimental group SC will be harmonized among the study centres to include aspirin treatment Patients will be assessed at 1 3 6 and 12 months Magnetic imaging and angiography MRIMRA will be done at 1 3 and 6 months
Number of Participants 70 participants in total 35 per treatment arm
Study duration 48 months
Study Centres International multi-centre study with approximately 20 to 30 centres
Participating countriesSwitzerland Germany France Austria Great Britain Australia
Centres in additional countries might be considered
Statistical Considerations The sample size is based on the comparison of the primary outcome - the change in FCASS from baseline to 1 month - between the two treatment groups The standard deviation from 13 patients of a retrospective study was calculated The standard deviation of the baseline and follow-up FCASS was 30 and 33 respectively The standard deviation of the change in FCASS from baseline was 28 Based on the standard deviation of 28 and a two-sample means test 64 patients 32 in each group are required to detect a difference of 20 with a power of 80 at a two-sided alpha-level of 005 To account for dropouts 8 we enlarge the sample size to 70 patients 35 in each group The primary analysis will follow the intention-to-treat ITT principle ie all patients will be analysed in the allocated group regardless of any protocol violations such as cross-overs The primary outcome change in FCASS from baseline to 1 month as well as other secondary continuous score outcomes that are measured multiple times during follow-up RRQ mRS Pediatric Stroke Outcome Measure PSOM VABS modAspect will be assessed in a repeated-measure mixed-effects linear model
Good Clinical Practice GCP Statement This study will be conducted in compliance with the protocol the current version of the Declaration of Helsinki International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ICH-GCP as well as all national legal and regulatory requirements
Rationale There is increasing evidence that etiologically inflammatory processes play a crucial role in childhood stroke and influence outcome Retrospective analyses suggest improved outcome and less recurrence with steroid treatment With the exception of sickle cell disease this study will be the first randomized clinical trial in children with arterial ischemic stroke It will provide high-level evidence for the most appropriate treatment for children with AIS due to FCA Alignment of interventions and outcome as well as pooled analysis with the planned Focal Cerebral Arteriopathy Steroid FOCAS study in North America will allow pooled analysis resultsThis is very important in view of the marked neurological social and economic burden of childhood AIS for patients and families This project has been identified as the most important AIS treatment trial by a Delphi survey of international paediatric stroke experts and is one of the most important research priorities identified by parents In addition the study will provide insights into the pathogenesis of inflammatory vasculopathiesThe objective of this trial is to show that children with first stroke event due to unilateral FCA treated with a combination of high dose steroid and aspirin will have better and quicker recovery of arteriopathy better clinical functional outcome and less recurrence compared to children treated with aspirin alone
The proposed study is a prospective multicentre parallel group two-arm randomized controlled open-label clinical trial with blinded outcome assessment comparing a high dose course of methylprednisolone prednisolone plus standard of care with standard of care alone in children with unilateral arteriopathy and acute ischemic stroke
Measurements and procedures Participants will be randomized within 48 hours after diagnosis maximum 96 hours after stroke onset to standard of care SC alone control group or SC plus steroids experimental group SC will be harmonized among the study centres to include aspirin treatment Patients will be assessed at 1 3 6 and 12 months Magnetic imaging and angiography MRIMRA will be done at 1 3 and 6 months
Number of Participants 70 participants in total 35 per treatment arm
Study duration 48 months
Study Centres International multi-centre study with approximately 20 to 30 centres
Participating countriesSwitzerland Germany France Austria Great Britain Australia
Centres in additional countries might be considered
Statistical Considerations The sample size is based on the comparison of the primary outcome - the change in FCASS from baseline to 1 month - between the two treatment groups The standard deviation from 13 patients of a retrospective study was calculated The standard deviation of the baseline and follow-up FCASS was 30 and 33 respectively The standard deviation of the change in FCASS from baseline was 28 Based on the standard deviation of 28 and a two-sample means test 64 patients 32 in each group are required to detect a difference of 20 with a power of 80 at a two-sided alpha-level of 005 To account for dropouts 8 we enlarge the sample size to 70 patients 35 in each group The primary analysis will follow the intention-to-treat ITT principle ie all patients will be analysed in the allocated group regardless of any protocol violations such as cross-overs The primary outcome change in FCASS from baseline to 1 month as well as other secondary continuous score outcomes that are measured multiple times during follow-up RRQ mRS Pediatric Stroke Outcome Measure PSOM VABS modAspect will be assessed in a repeated-measure mixed-effects linear model
Good Clinical Practice GCP Statement This study will be conducted in compliance with the protocol the current version of the Declaration of Helsinki International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ICH-GCP as well as all national legal and regulatory requirements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-005571-39 | EUDRACT_NUMBER | None | None |