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Tezspire Cardiac Events PASS
RECRUITINGSponsored by AstraZeneca
Actively Recruiting
SponsorAstraZeneca
Started2025-09-15
Est. completion2029-05-31
Eligibility
Age12 Years – 130 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06951867
Summary
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.
Eligibility
Age: 12 Years – 130 YearsHealthy volunteers accepted
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
Conditions4
AsthmaCardiovascular EventsHeart DiseaseMACE
Locations1 site
Healthcare Integrated Research Database (HIRD)
Wilmington, Delaware, 19801
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Actively Recruiting
SponsorAstraZeneca
Started2025-09-15
Est. completion2029-05-31
Eligibility
Age12 Years – 130 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06951867