Tezspire Cardiac Events PASS
Recruiting · NCT06951867 · Observational (researchers observe without assigning treatment) · Lead sponsor: AstraZeneca
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The aim of this study is to evaluate the risk of serious adverse cardiovascular events in adolescent and adult patients with severe asthma taking tezepelumab compared to a population receiving standard of care treatment for severe asthma.
Who can take part
Age range
12 Years to 130 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- patients with a diagnosis of asthma receiving tezepelumab or high-intensity SOC treatment for severe asthma at any point during the study inclusion period.
Exclusion criteria
- for both exposed and unexposed groups include:
- \<12 months of data availability prior to index date,
- age \<12 years at index date,
- history of congenital heart disease or heart transplant outcome-specific exclusion criterion applied for each objective will include the presence of non-fatal myocardial infarction or stroke and the specific outcome of interest in the 180 days prior to index date
- for comparative analysis, an additional exclusion criterion will be considered, i.e. exposure to non-tezepelumab biologics on index date or within the 5-half-life clearance period of the biologic
- matching criteria (including, among other variables, the type and duration of SOC exposure in the 12 months before index date and propensity score \[PS\] matching) will be applied to ensure exposed and unexposed patients' comparability
Where it is running
4 locations listed across 1 US state.
- Healthcare Integrated Research Database (HIRD) - Wilmington, Delaware, United States
- Team Gesundheit GKV Claims data (SHI) - Berlin, Germany
- Danish registries (access/analysis) - Copenhagen, Denmark
- French National Health Data System (SNDS) - Paris, France