Phase 3 Heart Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have a specific genetic background and have been hospitalised for a serious heart event called an acute coronary syndrome (ACS) within the past 3 months
• People aged 45 years or older at the screening visit, both male and female
• People whose genetic test (called a Genotype Assay Test, done at an approved testing site) shows a specific result known as the "AA genotype" at a particular gene variant
• People who have been medically stable for at least one week before joining — meaning no chest pain or heart symptoms while resting or with very light activity
• People who have already been receiving standard recommended treatment to manage their LDL cholesterol (often called "bad cholesterol"), including both medication and dietary changes
• People who can be enrolled within 3 months of their original heart event

Who may not be able to join:

• Women who are pregnant or breastfeeding (a pregnancy test is required for women who could become pregnant)
• Women who could become pregnant and are not using at least one highly effective form of contraception, unless they have had a surgical procedure that prevents pregnancy or have gone through menopause (defined as no periods for more than 12 months)
• People with severe heart failure (classified as NYHA Class III or IV — confirm with trial site if unsure which class applies)
• People whose heart event appears to have been caused by uncontrolled high blood pressure
• People with very high blood pressure (systolic above 180 mmHg and/or diastolic above 110 mmHg) at the time of joining, even while on blood pressure medication
• People with obvious signs of liver disease, such as jaundice, bile flow problems, or reduced liver function, or who have had significantly elevated liver enzyme levels (ALT or AST more than 3 times the normal upper limit) within the past 6 months
• People who have had persistently and unexplainably high levels of a muscle enzyme called CPK (more than 5 times the normal upper limit) within the past 6 months
• People whose kidneys are functioning at a very low level (eGFR below 30 mL/min/1.73m²) based on tests within the past 6 months
• People with a history of cancer or another serious health condition that could affect their ability to participate in the study, or people whose life expectancy is estimated to be less than 3 years
• People with any recent abnormal laboratory result that the trial doctor considers likely to interfere with safe participation in the study (confirm with trial site)
• People who have taken part in another clinical trial involving an experimental drug within the past month, or who plan to join another experimental drug or device study during this trial
• People who had coronary artery bypass graft (CABG) heart surgery between their original heart event and the point of joining this trial

Important: Always verify eligibility with the trial site directly before applying.