2022-500631-36-00招募中3 期
High Dose Steroids in Children with Stroke and Unilateral Focal Arteriopathy: A Multicentre Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 17
- 主要终点
- The primary outcome is change in FCA Severity Score (FCASS) from baseline to 1 month
研究概览
简要总结
The purpose of this study is to evaluate if additional early anti-inflammatory treatment may influence the course of arteriopathy and improve clinical outcome and may prevent stroke recurrence in children with stroke and unilateral focal arteriopathy. The primary objective of this study is to determine if a high dose course of methylprednisolone/prednisolone in addition to standard of care including antithrombotic treatment results in better improvement of focal arteriopathy in children with acute ischemic stroke and focal arteriopathy compared to standard of care alone.
研究设计
- 分配方式
- Randomized
- 主要目的
- Phase 3 prospective randomized controlled open label study
- 盲法
- Single (Analyst)
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Informed consent of the legal representative of the trial participant documented by signature
- •Age > 6 months & < 18 years at time of stroke
- •Randomisation possible within 48 hours of diagnosis and maximum 96 hours after stroke onset
- •Unilateral arteriopathy according to the following criteria: • Newly acquired neurologic deficits • Specific neuroimaging (MRA) features of either - unilateral stenosis, or - unilateral vessel irregularities within the CNS
- •Unless otherwise defined in the national addendum: Female participants age ≥ 13: Negative pregnancy test (blood or urine)
排除标准
- •Previous stroke
- •Progressive large to medium childhood primary angiitis of the CNS (cPACNS ) with 2 of the following 3 criteria: a. pre-existing progressive neurocognitive dysfunction b. bilateral MRI lesions/vessel involvement c. small vessel arterial stenosis
- •On steroid treatment at disease onset
- •Contraindication to steroid treatment as e.g. a congenital or acquired immunodeficiency
- •Inability to follow the procedures of the study, e.g. due to language problems
- •Participation in another interventional study within the 30 days preceding the indication stroke and during the present study
- •Known syndromal disorders, as e.g. Trisomy 21, Neurofibromatosis type 1
- •Known genetic vasculopathies as e.g. PHACES syndrome, ACTA II
- •Moyamoya or sickle cell disease
- •Small vessel cerebral vasculitis (primary CNS vasculitis)
- •Bilateral arteriopathy
- •Arterial dissection(s)
- •Evidence of underlying systemic disorders, as e.g. lupus, rheumatoid problems
- •Secondary CNS angiitis due to infections (meningitis, endocarditis, borreliosis), or generalised angiitis due to rheumatic or other autoimmune problems
结局指标
主要结局
The primary outcome is change in FCA Severity Score (FCASS) from baseline to 1 month
The primary outcome is change in FCA Severity Score (FCASS) from baseline to 1 month
次要结局
- Neurological deficits over time as determined by PSOM, RRQ, modified Rankin scale (mRS) and Vineland Adaptive Behaviour Scale (VABS) at 6 and 12 months
- Neurocognitive outcome at 12 months
- Recurrence-free survival
- Change in FCASS at (3) and 6 months
- Residual vasculopathy at 6 months
研究者
Prof.em.Dr.med Maja Steinlin
Scientific
Insel Gruppe AG
研究点 (17)
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