C-REGS2 - a Registry Study to Observe Clinical Practices, Safety and Efficiency of Routine Use of Cerebrolysin in the Treatment of Patients with Moderate to Severe Neurological Deficits After Acute Ischaemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,851
- 试验地点
- 8
- 主要终点
- Ordinal modified Rankin Scale (mRS) at 3 months after stroke onset
研究概览
简要总结
This study investigates the clinical practices, safety and effectiveness of Cerebrolysin in routine treatment of patients with moderate to severe neurological deficits after acute ischemic stroke.
详细描述
Patients registered: Acute Ischemic Stroke patients with moderate to severe neurological deficits
All patients receive acute stroke care according to local treatment standards, not amended or influenced by the study:
Cerebrolysin Group:
Patients who are treated with Cerebrolysin; dosage, frequency and duration follows local clinical practice in accordance with terms of the local marketing authorization
Control group:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent
- •Clinical diagnosis of acute ischemic stroke confirmed by imaging
- •Moderate to severe neurological deficits with NIH Stroke Scale (NIHSS) 8 to 15, both inclusive
- •No prior stroke
- •No prior disability
- •Patient's independence prior to stroke onset (pre-morbid mRS of 0 or 1)
- •Reasonable expectation of successful follow-up (max. 100 days)
排除标准
- 未提供
研究组 & 干预措施
Cerebrolysin and standard stroke care
干预措施: Cerebrolysin (Drug)
结局指标
主要结局
Ordinal modified Rankin Scale (mRS) at 3 months after stroke onset
时间窗: 3 months
The modified Rankin Scale scale is used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death.
次要结局
- Ordinal modified Rankin Scale (mRS) at 21 days after stroke onset(21 days)
- Ordinal NIH Stroke Scale (NIHSS) at 21 days and 3 months after stroke onset(Day 21 and 3 months)
- Ordinal MoCA at 3 months after stroke(3 months)
- Proportion of patients with functional independence (mRS score 0-2) at 3 months after stroke onset(3 months)
- Proportion of patients with excellent recovery (mRS score 0-1) at 3 months after stroke onset(3 months)