NCT06951867Recruiting
Tezspire Cardiac Events PASS
An Observational Multi-Country Post-Authorisation Safety Study to Evaluate the Risk of Serious Adverse Cardiovascular Events in Adolescent and Adult Patients With Severe Asthma Taking Tezepelumab
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 16640 (estimated)
- First submitted
- 23 Apr 2025
- Start date
- 15 Sept 2025
- Primary completion date
- 31 May 2029
- Lead sponsor
- AstraZeneca
- Diseases
- Heart failure, Coronary artery disease, Stroke, Asthma
- NCT number
- NCT06951867
What you commit to
- Study type: Observational
- Planned participants: 16640
- From 15 Sept 2025 to the primary completion date, 31 May 2029
- 4 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- \<12 months of data availability prior to 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
- 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
Lab values
- 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
Age
- age \<12 years at index date,
Who the study is looking for
- patients with a diagnosis of asthma receiving tezepelumab or high-intensity SOC treatment for severe asthma at any point during the study inclusion period.
Age in the registry: 12 years to 130 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Team Gesundheit GKV Claims data (SHI) Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Danish registries (access/analysis) Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
| French National Health Data System (SNDS) Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Healthcare Integrated Research Database (HIRD) Coordinator of this site? Confirm its status | Wilmington | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.