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临床试验/NCT05401149
NCT05401149已完成不适用

Effectiveness and Safety of IV Rt-PA Treatment in Chinese AIS Patients Aged Above 80 Years: a Real-world Study

Boehringer Ingelheim1 个研究点 分布在 1 个国家目标入组 3,058 人开始时间: 2022年7月18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
3,058
试验地点
1
主要终点
Percentage of Patients With Favourable Outcome (Modified Rankin Scale (mRS) 0-1) at 1 Year

研究概览

简要总结

The objective of this study is to find out if Chinese Acute Ischaemic Stroke (AIS) patients older than 80 years benefit from intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) treatment within 4.5 hours of symptom onset 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
80 Years 至 —(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

Acute Ischaemic Stroke (AIS) patients aged > 80 years who received intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) (Alteplase) within 4.5 hours of symptom onset

干预措施: rt-PA (Drug)

结局指标

主要结局

Percentage of Patients With Favourable Outcome (Modified Rankin Scale (mRS) 0-1) at 1 Year

时间窗: Up to 1 year post index hospital admission (between January 2017 and March 2020); data retrieved and studied from July 18, 2022 to December 14, 2022 (approximately 5 months of this study).

Percentage of patients with favourable outcome (modified Rankin Scale (mRS) 0-1) at 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. 2. - Slight disability. 3. - Moderate disability. 4. - Moderately severe disability. 5. - Severe disability. 6. - Dead. Reported percentages of subjects were calculated from the conditional logistic regression models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline National Institutes of Health Stroke Scale (NIHSS) score, and time from symptom onset to hospital admission.

次要结局

  • Percentage of Patients With Any Intracranial Haemorrhage (ICH) During Hospitalisation(Up to 3 months)
  • All-cause Mortality During Hospitalisation(Up to 3 months)
  • Percentage of Patients With Independence (Modified Rankin Scale (mRS) 0-2) at 1 Year(Up to 1 year post index hospital admission (between January 2017 and March 2020); data retrieved and studied from July 18, 2022 to December 14, 2022 (approximately 5 months of this study).)
  • Distribution of Modified Rankin Scale (mRS) Score at 1 Year(Up to 1 year post index hospital admission (between January 2017 and March 2020); data retrieved and studied from July 18, 2022 to December 14, 2022 (approximately 5 months of this study).)
  • All-cause Mortality at 1 Year(Up to 1 year post index hospital admission (between January 2017 and March 2020); data retrieved and studied from July 18, 2022 to December 14, 2022 (approximately 5 months of this study).)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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