PREEMPT - Clinical Trial
What is the 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.
This study is about early heart disease. It looks at people who may have a small buildup in the blood vessels of the heart, called plaque, even if they do not feel sick or have symptoms. This buildup can start before serious heart problems happen. People who join the study show early signs of this buildup on heart scans but have not had major heart problems like a heart attack or stroke. The goal of the study is to find better ways to detect early heart disease and learn if certain medicines can help slow it down or make it better over time.
Who Can Participate in the Study?
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.
What is Involved?
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.