A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event (AZURE-Outcomes)
A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Effect of AZD0780 on Major Adverse Cardiovascular Events in Patients With Established Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk for a First ASCVD Event
Sponsor: AstraZeneca
A observational or N/A phase clinical study on Cardiovascular Disease, this trial is actively recruiting participants. The trial is conducted by AstraZeneca and has accumulated 10 data snapshots since 2025. Cardiovascular trials of this type often inform treatment guidelines for long-term patient management.
Status Flow
Change History
10 versions recorded-
Apr 18, 2026 — Present [daily]
Recruiting
Phase: PHASE3 → None
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Mar 2026 — Apr 2026 [monthly]
Recruiting PHASE3
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Feb 2026 — Mar 2026 [monthly]
Recruiting PHASE3
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Jan 2026 — Feb 2026 [monthly]
Recruiting PHASE3
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Dec 2025 — Jan 2026 [monthly]
Recruiting PHASE3
▶ Show 5 earlier versions
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Nov 2025 — Dec 2025 [monthly]
Recruiting PHASE3
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Oct 2025 — Nov 2025 [monthly]
Recruiting PHASE3
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Sep 2025 — Oct 2025 [monthly]
Recruiting PHASE3
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Jul 2025 — Sep 2025 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
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Jun 2025 — Jul 2025 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility Summary
The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event. The effect of AZD0780 vs placebo on the risk of MACE-PLUS will be evaluated from randomisation until the primary analysis censoring date (PACD). The Study Closure Visit will be scheduled to occur after the PACD and will be the final visit for each participant in the study.
Contact Information
- AstraZeneca
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
A Coruña, Spain , A Coruña, Spain , Aarhus N, Denmark , Acapulco, Mexico , Afyonkarahisar, Turkey (Türkiye) , Aguascalientes, Mexico , Ahmedabad, India , Alexandroupoli, Greece , Alicante, Spain , Alingsås, Sweden and 1254 more locations