1-year clinical outcomes after intravenous rt-PA for Chinese AIS patients (0135-0350)

Study type

• Study topic:
  Disease /health condition

  Other
• Study topic, other:
  Disease/Epidemiology study
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Study drug and medical condition

• Additional medical condition(s):
  Acute Ischaemic Stroke

Population studied

• Short description of the study population:
  Patients with acute ischaemic stroke
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with acute ischaemic stroke
• Estimated number of subjects:
  11700

Study design details

• Main study objective:
  • All-cause mortality at 1 year (mRS=6)
• Outcomes:
  • All-cause mortality at 1 year (mRS=6), • Functional independence (mRS 0-2) at 1 year • Favourable clinical outcome (mRS 0-1) at 1 year • mRS 5-6 at 1 year • Distribution of mRS score at 1 year
• 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 characteristics 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.