Temporal trends of thrombolysis treatment in Chinese acute ischemic stroke (AIS) patients from 2007 2017: analysis of China National Stroke Registry (CNSR) I, II, and III

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  ACTILYSE
• Medical condition to be studied:
  Ischaemic stroke

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  50.000

Study design details

• Main study objective:
  This is a non interventional study based on existing data from the CNSR.
• Outcomes:
  For all the three waves of CNSR, the following primary outcomes will be assessed: Proportion of patients who received IV rtPA treatment within 3h of symptom onset (patient group C) among 2hr IVT eligible patients (patient group B), Proportion of patients who received IV rtPA treatment within 4.5h of symptom onset (patient group C’) among 3.5h IVT eligible patients (patient group B’). Among all AIS patients: Proportion of patients who arrived at hospital within 2h of symptom onset and who received IV rtPA treatment within 3h of symptom onset  Proportion of patients who arrived at hospital within 3.5h of symptom onset and who received IV rtPA treatment within 4.5h of symptom onsetFor other secondary outcomes, please refer to protocol.
• Data analysis plan:
  The study is descriptive in nature. For continuous data, descriptive statistics (number of patients, mean, standard deviation SD, minimum, median, interquartile range, and maximum) will be presented. Categorical data will be presented as frequency and proportion with 95% CI as appropriate.Selected outcomes will be analyze with data from hospital participated across all phases of CNSR. These outcomes will also be standardized by hospital (based on phase III).