Effectiveness and safety of IV rt-PA treatment in Chinese AIS patients aged above 80 years: a real-world study (0135-0349)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Elderly (≥ 65 years)

      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  1301

Study design details

• Main study objective:
  • To compare the 1-year neurological functional outcome (as measured by modified Rankin Scale mRS score) of Chinese AIS patients aged > 80 years receiving IV rt-PA treatment within 4.5 hours of symptom onset versus those who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive reperfusion therapy.
• Outcomes:
  • To compare the 1-year neurological functional outcome (as measured by modified Rankin Scale mRS score) of Chinese AIS patients aged > 80 years receiving IV rt-PA treatment within 4.5 hours of symptom onset versus those who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive reperfusion therapy. • Any intracranial haemorrhage (ICH) during hospitalisation • All-cause mortality during hospitalisation • Independence (mRS 0-2) at 1 year • Distribution of mRS score at 1 year • All-cause mortality at 1 year • Baseline characteristics (age, gender, NIHSS, etc.)
• Data analysis plan:
  To account for potential confounding, the study cohorts (patients who received IV rt-PA and patients who did not receive reperfusion treatment) will be matched by baseline characteristics using the propensity score matching (PSM) method. The PSM aims to balance the 2 treatment cohorts on baseline covariates. The feasibility of PSM will be evaluated based on available sample size and descriptive results. If patient characteristic between the 2 cohorts are significantly different, the study design will be re-evaluated before proceeding to analysis. The Nearest Neighbour method of PSM will be used to select the matched samples. The final list of baseline characteristics in the PSM will be decided in conjunction with Boehringer Ingelheim. All the variables listed in the covariates will be considered. The distribution of baseline characteristics will be presented before and after the matching process.