Open for Enrollment Soon
This study will open for enrollment soon. Please contact the study team for more information and check back frequently.

AZURE - Clinical Trial

What is the Purpose of this Study?

If you qualify for the study, a computer will choose your medicine by chance. This means you could get AZD0780 or a pill that does not have medicine, called a placebo. It is like flipping a coin, so you have a 1 in 2 chance of getting AZD0780. Neither you nor your doctor will know which one you get. You will take one pill by mouth every day. Each pill is 30 milligrams.

You will visit the study site up to 15 times. These visits will happen at the start and then at different weeks, like week 0, 2, 4, 12, and so on. Each visit will take about 1 to 2 hours. Your doctor will tell you what tests and steps you need to do. Before each visit, you cannot eat or drink anything except water for at least 8 hours. You can drink water during this time.

What is the Condition Being Studied?

This study is a big test to see if a new medicine called AZD0780 can help prevent serious heart problems. It will include people who already have heart disease or people who might get it soon. The study will compare AZD0780 to a fake pill to see which works better. No one in the study will know which pill they are taking until the end.

Who Can Participate in the Study?

This study is looking for people who might have heart or blood vessel problems. There are two main groups:

First group: People who already had a heart or blood vessel problem. They must be at least 18 years old and have had one of these in the past year:

- A heart attack

- A stroke caused by blocked blood vessels

- Surgery to fix poor blood flow in the legs

They also need to have a certain amount of bad cholesterol (called LDL) in their blood. If their LDL is lower, they need extra risk factors like diabetes, being 65 or older, kidney problems, or other health issues.

Second group: People who have not had a heart problem yet but are at high risk. Men must be 50 or older, and women must be 55 or older. They need to have high LDL cholesterol and signs of artery disease, diabetes with organ damage, or other risk factors like smoking or kidney disease.

Age Group
Adults

What is Involved?

This study wants to find out if a medicine called AZD0780 can help lower the chance of having serious heart problems. It will compare AZD0780 to a pill that does not have medicine in it, called a placebo. The study will look at people who already have heart disease or people who might get it soon.

Study Details

Full Title
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
Principal Investigator
Nishant P. Shah, MD
Cardiologist
Protocol Number
IRB: PRO00119072
NCT: NCT07000357
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment Soon
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