Tezspire Cardiac Events PASS
Recruiting now
Conditions studied: Cardiovascular Events, MACE
In brief
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.
Key facts
- Study ID
- NCT06951867
- Run by
- AstraZeneca
- People needed
- 16640
- Starts
- 2025-09-15
- Expected to finish
- 2029-05-31
- Last updated by the study team
- 2026-07-27
Who can join
Age: 12 and older, up to 130. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Healthcare Integrated Research Database (HIRD) — Wilmington, Delaware, United States (enrolling)
- Danish registries (access/analysis) — Copenhagen, Denmark (enrolling)
- French National Health Data System (SNDS) — Paris, France (enrolling)
- Team Gesundheit GKV Claims data (SHI) — Berlin, Germany (enrolling)
Full record on ClinicalTrials.gov
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