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.
Who Can Participate?
Eligibility
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 Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
Yes
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
Shah
Protocol Number
PRO00119072
NCT ID
NCT07000357
Phase
III
Enrollment Status
Pending Open to Enrollment