LDL-C Management Following Acute Coronary Syndrome
This is a research study to find out if a study drug may help people who have atherosclerotic heart disease and high “bad” cholesterol with a recent acute coronary syndrome.
The study will include about 384 people who have atherosclerotic cardiovascular disease and high “bad” cholesterol at approximately 65 centers in the United States Patients who join the study will be followed for up to 12 months.
You may be eligible if you:
- Had a recent Acute Coronary Syndrome (Myocardial infarction/heart attack or unstable angina) within 5 weeks
- Have elevated LDL cholesterol
- Are currently taking a statin (or have a documented intolerance)
When there is too much cholesterol in your blood, it builds up in the walls of your arteries, causing a process called atherosclerosis. The arteries become narrowed and blood flow to the heart is slowed down or blocked.
Participants will be assigned into 1 of 2 treatment groups:
- Study drug in addition to current therapy
- Usual care/current therapy without the study drug
Participants assigned to receive the study drug will receive this by injection under the skin 3 times over the course of the study.
All participants will continue with their current treatment therapy for managing cholesterol and cardiovascular disease.
You will have 5 visits with your study doctor over 12 months and you will be given 1 injection on the second, third, and fourth visits.
During the study visits, the study team will:
- Ask you about your health and how you have been feeling
- Conduct a study-related exam
- Administer study-related tests
- Ask you to complete questionnaires
Clinical research studies are done to better understand the safety of a study drug or procedure and how it works in the body. Clinical trials may help to develop new medicines and treat conditions such as heart disease. Qualified doctors run clinical trials. They are responsible for the study-related care of the people who join the study.
Your participation in this study will help researchers and doctors better understand how certain medications affect overall heart health.
Should you qualify to take part in the study, you may receive:
- Study medication at no cost
- Study-related medical care at no cost, including physical exams and laboratory tests
Study doctors and their staff will respect the privacy of all patients who take part in the study. Details about your health will be kept as confidential as possible.
Information on how your health information is collected and kept private is explained in the Informed Consent Form.
View study on ClinicalTrials.gov