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

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• 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:
  50000

Study design details

• Main study objective:
  In order to understand the impact of these efforts on the clinical practices for AIS treatment in China, we plan to evaluate the 10 year temporal changes from 2007 2017, in the IV rtPA treatment proportion and treatment time intervals of AIS patients by using the CNSR phase I, II, and III. In addition, the demographic and clinical characteristics of the AIS patients will be described.
• Outcomes:
  • To investigate the temporal changes in the proportion of intravenous recombinant plasminogen activator (IV rtPA) treatment from 2007 to 2017 among intravenous thrombolytics (IVT) eligible patients and overall AIS patients in China,• To investigate the temporal changes in IV rtPA treatment time intervals from 2007 to 2017 among IV rtPA treated patients in China. • To describe the demographic and clinical characteristics of the IV rtPA treated patients, IVT eligible patients and the overall AIS patients from the CNSR phase I to phase III
• 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).