Tezspire Cardiac Events PASS
TRESPASS
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
1 other identifier
observational
16,640
4 countries
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2025
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2025
CompletedFirst Posted
Study publicly available on registry
April 30, 2025
CompletedStudy Start
First participant enrolled
September 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2029
April 8, 2026
April 1, 2026
3.7 years
April 23, 2025
April 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
composite outcome MACE
The primary outcome of interest is the composite outcome MACE, consisting of non-fatal myocardial infarction, non-fatal stroke, or cardiovascular death.
five years from tezepelumab market launch
Secondary Outcomes (1)
composite of four serious adverse cardiovascular events
five years from tezepelumab market launch
Study Arms (2)
tezepelumab severe asthma patients
patients with a diagnosis of severe asthma receiving tezepelumab
tezepelumab unexposed asthma patients
patients with a diagnosis of severe asthma receiving non-tezepelumab standard of care for severe asthma
Interventions
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.
Eligibility Criteria
The study will be conducted using data sources from Denmark, France, Germany, and the United States of America (USA). The source population will consist of patients with a diagnosis of asthma receiving tezepelumab or high-intensity SOC treatment for severe asthma at any point during the study inclusion period. From this source population, the exposed study population (i.e. patients who initiate tezepelumab treatment) and the unexposed study population (i.e. comparable patients who are unexposed to tezepelumab) will be identified.
You may not qualify if:
- \<12 months of data availability prior to index date,
- age \<12 years at 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- IQVIA Pvt. Ltdcollaborator
Study Sites (4)
Healthcare Integrated Research Database (HIRD)
Wilmington, Delaware, 19801, United States
Danish registries (access/analysis)
Copenhagen, Denmark
French National Health Data System (SNDS)
Paris, France
Team Gesundheit GKV Claims data (SHI)
Berlin, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Egger
IQVIA Pty Ltd
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2025
First Posted
April 30, 2025
Study Start
September 15, 2025
Primary Completion (Estimated)
May 31, 2029
Study Completion (Estimated)
May 31, 2029
Last Updated
April 8, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved, AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.