This is a multicenter, randomised, double-blind, placebo-controlled, study to evaluate the safety, tolerability, and efficacy of AZD0780 versus placebo. The study is looking at whether treatment with the study drug, AZD0780 (versus placebo) can lower the risk of serious heart and blood vessel problems. Approximately 15,1000 participants ≥ 18 years with a history of or at risk for a cardiovascular event will be recruited across 1000 study sites in over 30 countries.
AZURE CVOT
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
Cardiovascular diseases
All genders
18-100
Recruiting now
Overview
Principal Investigator: Anastassios Pittas
Contact Us
Elise Reitshamer / Endocrinology Research
Study details
Inclusion Criteria
- Age 18 or older with a cardiovascular event in the past year and LDL greater than or equal to 60 mg/dL or Age 50 or older at risk for a cardiovascular event and LDL greater than or equal too 100 mg/dL
- Taking a maximally tolerated dose of statin
Exclusion Criteria
- Revascularisation procedure planned in the next 3 months
- Uncontrolled type 2 diabetes defined as HbA1c >9.4%
- Taking or planning to take any of the excluded medications: mipomersen or lomitapide (within past 12 months), gemfibrozil (within past week), evolucumab/alirocuumab (within past 12 months), or inclisiran (within past 18 months)
Study Requirements
During this study, participants will be asked to come to the study center approximately 7 times in the first year and every 6 months thereafter. At visits, participants will undergo a physical exam and ECG (a snapshot of the heart's activity), have detailed medication and medical history collected, provide blood samples, complete questionnaires, and take a daily study drug. Participants will be asked to take the study drug (or placebo) once daily.