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.
研究者
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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