Checks heart and blood vessel safety of tezepelumab in people with severe asthma
Compares serious heart problems in teens and adults with severe asthma taking tezepelumab.
Key facts
- Who runs it
- AstraZeneca
- Where
- Wilmington, United StatesSee the siteAlso in 3 other countries, 3 sites
- Trial code
- Registry title
- Tezspire Cardiac Events PASS
- Status
- Recruiting
- People taking part
- 16,640 people, planned
- Started
- 15 Sept 2025
- Expected to end
- 31 May 2029
- Type of study
- Observational, 2 groups
- Treatments tested
- Tezepelumab
- Record updated
- 18 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for teenagers and adults with a diagnosis of asthma who take tezepelumab or high-intensity standard treatment for severe asthma. It looks at serious heart and blood vessel events.
- Age
- 12 years and older (up to 130 years).
- Sex
- All sexes can join.
- Disease stage
- Severe asthma.
- Earlier treatment
- Taking tezepelumab or high-intensity standard-of-care treatment for severe asthma during the study inclusion period. For the comparison, people cannot have been on other biologic drugs on the index date or within the 5-half-life clearance period.
Main reasons for not taking part
- Less than 12 months of data available before the index date
- Younger than 12 years at the index date
- History of congenital heart disease or heart transplant
- Non-fatal heart attack or stroke in the 180 days before the index date
- Exposure to non-tezepelumab biologics on the index date or within the 5-half-life clearance period (comparison analysis)
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- patients with a diagnosis of asthma receiving tezepelumab or high-intensity SOC treatment for severe asthma at any point during the study inclusion period
Who cannot take part
- <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
- 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 <12 years at index date,
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 130 years old?
Where in United States
Also in 3 other countries, 3 sites
- Healthcare Integrated Research Database (HIRD)Wilmington, United StatesTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- tezepelumab severe asthma patients
patients with a diagnosis of severe asthma receiving tezepelumab
Treatment: Tezepelumab
- tezepelumab unexposed asthma patients
patients with a diagnosis of severe asthma receiving non-tezepelumab standard of care for severe asthma
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Checks heart and blood vessel safety of tezepelumab in people with severe asthmaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06951867, who can take part
- Record updated
- 18 September 2026