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临床试验/NCT05697575
NCT05697575
招募中
不适用

Non-interventional Observational Study to Evaluate the Efficacy and Safety of Non-immune Staphylokinase in Reperfusion Therapy of Ischemic Stroke in Routine Clinical Practice

National Society for Neurosonology and Cerebral Circulation2 个研究点 分布在 2 个国家目标入组 336 人2023年2月1日
适应症Acute Stroke

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Acute Stroke
发起方
National Society for Neurosonology and Cerebral Circulation
入组人数
336
试验地点
2
主要终点
Proportion of intracerebral hemorrhage
状态
招募中
最后更新
19天前

概览

简要总结

The study will collect data from aged 18 to 85 years with a diagnosis of acute stroke, who received thrombolytic treatment with a new agent, nonimmunogenic staphylokinase. Outcomes will be checked for safety and compared to the results of treatment with the other thrombolytic drug, alteplase.

注册库
clinicaltrials.gov
开始日期
2023年2月1日
结束日期
2030年5月10日
最后更新
19天前
研究类型
Observational
性别
All

研究者

发起方
National Society for Neurosonology and Cerebral Circulation
责任方
Sponsor

入排标准

入选标准

  • Age 18-85 ;
  • Diagnosis of acute ischemic stroke eligible for thrombolytic therapy;
  • Thrombolytic therapy with the drug "non-immunogenic staphylokinase" is planned or has already been performed.

排除标准

  • Individual intolerance or known hypersensitivity to a recombinant protein containing the amino acid sequence of staphylokinase;
  • The presence of a contraindication to thrombolytic therapy of ischemic stroke;
  • Pregnancy or lactation.

结局指标

主要结局

Proportion of intracerebral hemorrhage

时间窗: 36 hours

Number and proportion of intracerebral bleeding of any type, which occurs as a complication of thrombolytic treatment

研究点 (2)

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