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

05/03/2020
31/03/2020
EU PAS number:
EUPAS33970
Study
Planned
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Study type

Study type

Non-interventional study

Scope of the study

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

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).