An observational study in Cardiovascular Events and MACE, sponsored by AstraZeneca. Recruiting at 4 sites in 4 countries. Open to participants aged 12 Years to 130 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by AstraZeneca · Observational
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Among 25 studies in Coronary Artery Disease by AstraZeneca — 1 open to participants now, 1 under way, none of them phase 3. Coronary Artery Disease · AstraZeneca.
Among the 25 studies in Coronary Artery Disease by AstraZeneca, this one is the only one that started in 2025, is one of 3 observational ones, and was the 25th registered.
4,862 studies on the registry are indexed under Coronary Artery Disease; 893 are open to participants now.
Browse Coronary Artery Disease studies →1 of the 25 studies in Coronary Artery Disease by AstraZeneca is open now, in 4 countries.
By country, each count listing its studies:
Of the 589 Coronary Artery Disease studies recruiting now, 403 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 48 take healthy volunteers.
This study: 12 Years to 130 Years · all sexes · no healthy volunteers.
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25 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 1 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 16,640 is above the median of 326 across 1,689 observational studies indexed under Coronary Artery Disease.
Median enrollment 76 across the 22 interventional studies, 10,568 across the 3 observational. Of the 24 that completed or were terminated, 11 (46%) have results posted.
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AstraZeneca is the lead sponsor of 3,503 studies on the registry; 273 are open to participants now.
Of its 369 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 25 studies in Coronary Artery Disease by AstraZeneca, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Tezepelumab (brand name: TEZSPIRE®), a human monoclonal antibody specific for the epithelial cell-derived cytokine thymic stromal lymphopoietin (TSLP), was recently launched as a first-in-class biologic add on treatment for patients with severe asthma. Results from DESTINATION, a long-term extension, phase 3 trial, showed a numeric imbalance in the occurrence of cardiac disorder system organ class serious adverse events (SAEs) in participants receiving tezepelumab compared to placebo. The observed imbalance resulted in the inclusion of serious cardiovascular events as an important potential risk to be addressed in the European Union (EU) risk management plan (RMP). AstraZeneca proposed to evaluate the risk of serious cardiovascular events with long-term tezepelumab treatment to meet regulatory requirements under a category 3 Post-Authorisation Safety Study (PASS).
This study is a non-interventional, longitudinal, population-based cohort study, using secondary data derived from multiple data sources. The study will consist of descriptive and a prevalent new-user design for comparative analyses of serious cardiovascular events outcomes in adolescent and adult patients with severe asthma exposed and unexposed to tezepelumab.
The study will be conducted using data sources from Denmark, France, Germany, and the United States of America (USA). The start of the study period will correspond to tezepelumab market launch date in each country of interest (i.e. between Q1 2022 - Q3 2023). An approximately five-year study period is planned in each country, with an anticipated last date of study period on 28 February 2029.
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.
Inclusion Criteria:
Exclusion Criteria for both exposed and unexposed groups include:
patients with a diagnosis of severe asthma receiving tezepelumab
Drug: Tezepelumab
patients with a diagnosis of severe asthma receiving non-tezepelumab standard of care for severe asthma
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.
Also known as: TEZSPIRE
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 launch
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 launch
Plan to share: Yes — 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.
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.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for May 2029, 44 months after the start.
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