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临床试验/NCT05395338
NCT05395338已完成不适用

1-year Clinical Outcomes After Intravenous Rt-PA for Chinese AIS Patients

Boehringer Ingelheim1 个研究点 分布在 1 个国家目标入组 12,551 人开始时间: 2022年4月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
12,551
试验地点
1
主要终点
All-cause Mortality at 1 Year (Percentage of Patients With Modified Rankin Scale (mRS) Score =6)

研究概览

简要总结

The objective of the study is to find out the 1-year clinical outcomes among Acute Ischaemic Stroke (AIS) patients who were treated with intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) within 4.5 hours of symptom onset compared with those who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive any reperfusion treatment in a real-world clinical setting.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

IV rt-PA cohort

Patients who received IV rt-PA within 4.5 hours of symptom onset

干预措施: rt-PA (Drug)

结局指标

主要结局

All-cause Mortality at 1 Year (Percentage of Patients With Modified Rankin Scale (mRS) Score =6)

时间窗: Up to 1 year.

The modified Rankin Scale (mRS) is used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, from 'perfect health without symptoms' to 'death'. 0 - No symptoms. 1. - No significant disability. Able to carry out all usual activities, despite some symptoms. 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. - Moderate disability. Requires some help, but able to walk unassisted. 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. - Dead.

次要结局

  • Percentage of Patients With Functional Independence (mRS Score 0 to 2) at 1 Year(Up to 1 year.)
  • Percentage of Patients With Favourable Outcome (mRS Score 0 to 1) at 1 Year(Up to 1 year.)
  • Percentage of Patients With mRS Score 5 to 6 at 1 Year(Up to 1 year.)
  • Distribution of mRS Score at 1 Year(Up to 1 year.)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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