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临床试验/NCT02541227
NCT02541227终止不适用

Cerebrolysin REGistry Study in Stroke A Registry Study to Assess Practices, Safety and Effectiveness of Cerebrolysin in Routine Treatment of Acute Ischemic Stroke

Ever Neuro Pharma GmbH1 个研究点 分布在 1 个国家目标入组 1,823 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
1,823
试验地点
1
主要终点
Modified Rankin Scale

研究概览

简要总结

Investigation of clinical practices, safety and effectiveness of Cerebrolysin in routine treatment of patients with acute ischemic stroke.

详细描述

Stroke is a devastating disease and one of the primary causes for death and long term morbidity imposing a heavy burden on patients, relatives and the health care system. Except for fibrinolytic therapy, which is only possible in a minor fraction of patients, there is no widely approved medication for the treatment of acute stroke.

Cerebrolysin has been approved for the treatment of stroke in over 45 countries worldwide.

Since the approval of Cerebrolysin, stroke therapy has evolved, namely, with improved overall care, stroke units, more targeted rehabilitation, and the increasing availability of fibrinolytic therapy (rtPA, Actilyse) in specialized centers throughout the world. More recently, interventional therapies with various thrombus retrievers have emerged.

In addition the Cerebrolysin treatment in stroke has evolved with different time windows, dosages and lengths of therapy being given in a pragmatic way by physicians within the specification of Product Characteristics for Cerebrolysin (SPC). The main aim of this study is to capture these variables of the Cerebrolysin treatment and its comedication in order to give guidance to further research. This research may consist of an extension of the current registry or targeted research in one or several subgroups of patients responding to Cerebrolysin treatment.

It is therefore the overall aim of this registry study to monitor the effectiveness and safety of Cerebrolysin therapy against the background of the now established and evolving stroke therapies. In the concomitant control group these therapies alone or in combination will be compared to the addition of Cerebrolysin in these patients. Of particular interest is the treatment in stroke units, with rtPA and systematic rehabilitation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Signed informed consent
  • Clinical diagnosis of acute ischemic stroke
  • 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 group

Patients who are treated with Cerebrolysin; dosage, frequency and duration follows local clinical practice in accordance with the terms of the local marketing authorization

干预措施: Cerebrolysin (Drug)

结局指标

主要结局

Modified Rankin Scale

时间窗: 90 days

Ordinal analysis of the mRS on day 90 was chosen as statistically powerful primary endpoint, as it is robust to case mix, clinically relevant and treatment-responsive.

次要结局

  • The National Institutes of Health Stroke Scale (NIHSS)(90 days)
  • Montreal Cognitive Assessment (MoCA)(90 days)
  • Home Time (number of nights among the first 90 days after stroke onset that the patient spends in his own or a relative's private home)(90 days)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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