Tezspire Cardiac Events PASS
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-130
SponsorAstraZeneca
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
patients with a diagnosis of asthma receiving tezepelumab or high-intensity SOC treatment for severe asthma at any point during the study inclusion period.
Disqualifiers
<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
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Tezepelumab
DrugThe 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.
Treatment groups
16,640 Participants
are divided into 2 treatment groupsGroup A: tezepelumab severe asthma patients1 intervention
Group B: tezepelumab unexposed asthma patients0 interventions
Trial outcomes
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.
Time frame
five years from tezepelumab market launchSecondary outcomes
1
composite of four serious adverse cardiovascular events
The secondary outcomes of interest are a composite of four serious adverse cardiovascular events, including arrhythmias, coronary artery disease, heart failure and myocardial disorders, and the individual components of the primary and secondary composite outcomes.
Time frame
five years from tezepelumab market launchSponsors and contacts
Click on the lead sponsor to view all of their trials.
AstraZeneca
Lead sponsor
IQVIA Pvt. Ltd
Collaborator
Source ClinicalTrials.gov