Safe Implementation of Treatments in Stroke (SITS) - Intravenous thrombolysis in acute ischaemic stroke patients over 80 years, SITS-IVT>80 years study (SITS ELDERLY)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Actilyse
• Medical condition to be studied:
  Ischaemic stroke

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:
  2000

Study design details

• Main study objective:
  Compare safety and efficacy of the use of IV rtPA in patients above 80 years of age, before the EU approval, and after.
• Outcomes:
   Safety: SICH per SITS-MOST definition Mortality (mRS=6) within 90 days Outcome: Functional Independency as defined by mRS 0-2 within 90 days, Patient characteristics at baseline including stroke severity (NIHSS) Outcomes: - Favourable outcome as defined by mRS 0-1 within 90 days - Secondary safety: SICH per ECASS 2 within 90 days - Delays of Management: Time from onset of symptoms – start of Treatment // Time from onset of symptoms – door (or as captured in the registry arrival at hospital) // Door – needle time
• Data analysis plan:
  A non-interventional post-approval study on SITS-ISTR existing data of intravenous rt-PA (0.9 mg/kg) in acute ischaemic stroke patients over 80 years, according to the Summary of Product Characteristics (SmPC) of European countries being part of the mutual recognition procedure within the academic SITS-ISTR (International Stroke Thrombolysis Registry, ongoing since December 2002).Descriptive statistics (absolute and relative frequencies, means, standard deviations, medians, inter quartile ranges, minimum and maximum values, 95% confidence intervals and proportions, as appropriate) for baseline and demographic characteristics for all included patients will be provided. To compare demographic and clinical baseline characteristics between pre-approval and post-approval patients over >80years, standardized differences will be used. Multivariable analyses (exploratory) with adjustment for differences or imbalances in prognostic variables for outcome comparison will be performed.