Purpose of this Study
People in this study will take part for about two years. During the study, they will have clinic visits, do some activities at home, and take part in phone or video check ins. They will have special heart scans and do blood tests at home to look for plaque, which is a buildup inside the heart blood vessels.
If they qualify for the study, people will be placed into one of four groups by chance. They may take one study medicine, two study medicines together, or pills with no medicine. The medicines being studied are rosuvastatin and colchicine. Everyone will take one pill each day, use a Fitbit and a smartphone program, and have another heart scan at the end of the study to see if their heart health has improved.
Who Can Participate?
Eligibility
People who may join this study include men who are between 30 and 50 years old and women who are between 40 and 60 years old. They should be mostly healthy and not have known heart disease. They should have a low risk of heart problems in the near future but may show early signs of plaque buildup in the heart on special scans. People cannot join if they have diabetes, have had a heart attack or stroke, or already take medicines to lower cholesterol or reduce inflammation. Participants must also be able to use a smartphone and be willing to follow the study steps.
Age Range
30-60
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
The purpose of this study is to learn better ways to find heart disease at an early stage, even before people feel sick or have symptoms. The study also looks at whether certain medicines can help slow down or improve the buildup inside the heart arteries. The goal is to help prevent serious heart problems in the future by finding and treating heart disease earlier.
Locations
Duke University Hospital
Other
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
Yes
Study Details
Full Title
Prospective RandomizEd Evaluation and Management of Premature aTherosclerosis
Principal Investigator
Nishant
Shah
Protocol Number
PRO00120252
NCT ID
NCT07232069
Phase
III
Enrollment Status
Pending Open to Enrollment