Tezspire Cardiac Events PASS

Conditions

• Cardiovascular Events
• MACE

Eligibility Criteria

Sex

ALL

Age

12 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

• Tezepelumab — DRUG
  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 Details

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.

Key Dates

Start date

Sep 15, 2025

Status verified

Jun 2026

Primary completion

May 31, 2029

Completion

May 31, 2029

Study Design

Enrollment

16,640 participants (estimated)

Arms

• Arm: tezepelumab severe asthma patients
  patients with a diagnosis of severe asthma receiving tezepelumab
• Arm: tezepelumab unexposed asthma patients
  patients with a diagnosis of severe asthma receiving non-tezepelumab standard of care for severe asthma

Primary Outcome Measure

composite outcome MACE [ Time Frame: five years from tezepelumab market launch ]

Central Contacts

• AstraZeneca Clinical Study Information Center
  1-877-240-9479
  [email protected]

Locations (1)

Find similar trials in Wilmington, DE

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