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Clinical Trials in Denmark / NCT06951867
Recruiting Observational

Tezspire Cardiac Events PASS

NCT06951867 · tracked via the Priya Life Science Denmark tracker
Sponsor
AstraZeneca
Phase
Observational
Started
2025-09-15
Last updated
2026-09-18

Condition(s) studied

Cardiovascular EventsMACE

Investigational drug(s) / intervention(s)

Tezepelumab →

Tezepelumab: The exposure of primary interest is tezepelumab for severe asthma. Exposure will be assessed based on prescriptions or administrations depending on the data source. A comparable cohort of unexposed patients treated with high-intensity SOC will be identified based on the presence of a trigger exposure (i.e., augmentation or change of the non-biologic high-intensity treatment that does not represent treatment de-escalation) to mirror tezepelumab start in the exposed cohort. Due to the limited knowledge of the cardiovascular profile of biologics, SOC for comparative analyses will only include non-biologic high-intensity treatment.

Study 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

Sex
ALL
Min age
12 Years
Max age
130 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • composite outcome MACE — five years from tezepelumab market launch
    The primary outcome of interest is the composite outcome MACE, consisting of non-fatal myocardial infarction, non-fatal stroke, or cardiovascular death.

Trial sites (4)

FacilityCityRegionStatus
Healthcare Integrated Research Database (HIRD) Wilmington Delaware Recruiting
Danish registries (access/analysis) Copenhagen Denmark Recruiting
French National Health Data System (SNDS) Paris France Recruiting
Team Gesundheit GKV Claims data (SHI) Berlin Germany Recruiting

On this site

📄 Tezspire (tezepelumab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06951867 on ClinicalTrials.gov ↗ ← All trials in Denmark