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临床试验/NCT05395351
NCT05395351已完成不适用

Characteristics and In-hospital Outcomes of Chinese Elderly (>80 Years) Patients With Acute Ischemic Stroke Receiving Intravenous Recombinant Tissue Plasminogen Activator Treatment Within 4.5 Hours of Symptom Onset

Boehringer Ingelheim1 个研究点 分布在 1 个国家目标入组 113,035 人开始时间: 2022年11月30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
113,035
试验地点
1
主要终点
All-cause Mortality During Hospitalization of Acute Ischemic Stroke (AIS) Patients

研究概览

简要总结

The objective of the study is to find out the in-hospital clinical outcomes among Chinese Acute Ischaemic Stroke (AIS) patients, who were treated with intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) within 4.5 hours of symptom onset in different age groups (18 to 80 years and above 80 years).

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

  • Patient registered in the Chinese Stroke Centre Alliance (CSCA) platform from Aug 2015 to Jul 2019
  • ≥18 years old
  • Diagnosed as Acute Ischemic Stroke (AIS) at admission
  • Arrived or admitted into hospital within 4.5 hours of symptom onset
  • For patients in the iv rt-PA groups only: received IV rt-PA within 4.5 hours of symptom onset

排除标准

  • Documented Intravenous Thrombolysis (IVT) absolute contraindication
  • Key data missing (age, gender, baseline National Institutes of Health Stroke Scale [NIHSS], time of symptom onset, IVT treated or not, time of IV alteplase treatment)
  • Received thrombolysis agents other than IV rt-PA (urokinase, tenecteplase, recombinant plasminogen activator, prourokinase, streptokinase)
  • Received endovascular treatment
  • Received IV rt-PA after 4.5 hours of symptom onset

研究组 & 干预措施

Acute ischemic stroke (AIS) patients aged >80 years who received IV rt-PA (Alteplase)

Group 1: Acute ischemic stroke (AIS) patients aged >80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.

干预措施: rt-PA (Drug)

Acute ischemic stroke (AIS) patients aged 18 to 80 years who received IV rt-PA (Alteplase)

Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV 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

All-cause Mortality During Hospitalization of Acute Ischemic Stroke (AIS) Patients

时间窗: Up to 100 days.

All-cause mortality during hospitalization of acute ischemic stroke (AIS) patients who received intravenous recombinant tissue plasminogen activator (IV rt-PA).

次要结局

  • Percentage of Patients With Hemorrhagic Stroke During Hospitalization(Up to 100 days.)
  • Change of NIHSS Score From Before Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment to 24 Hours After IV Rt-PA Treatment(Up to 24 hours.)
  • Modified Rankin Score (mRS) at Discharge(Up to 100 days.)
  • Number of Patients With Stroke Recurrence During Hospitalization(Up to 100 days.)
  • Length of Hospitalization(Up to 100 days.)
  • Percentage of Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment Among Acute Ischemic Stroke (AIS) Patients Arrived or Were Admitted to the Hospital Within 4.5 Hours of Symptom Onset(Up to 4.5 hours.)
  • Percentage of Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment Within 4.5 Hours of Symptom Onset Among Eligible AIS Patients (3.5-hour Arrival or Admission)(Up to 4.5 hours.)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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