Study for people who have or are at risk for heart disease, stroke, or PAD

Trial ID:
IRB-24-8414
James D McCallum, M.D.

Inclusion Criteria

Patients must:

  • Have elevated Lipoprotein(a) levels of =175 nanomoles per liter (nmol/L).
    Be 18 years of age or older
    Have atherosclerotic cardiovascular disease (ASCVD) with an event or revascularization; OR documented coronary artery disease (CAD), carotid stenosis, or peripheral artery disease (PAD) without history of event or revascularization; known familial hypercholesteremia; or a combination of high-risk factors.
    Meet all other eligibility criteria

Exclusion Criteria

Patients must not:

  • Have had a major cardiovascular event or surgery, such as myocardial infarction (MI), stroke or coronary or peripheral revascularization, < 90 days before screening.
    Have uncontrolled hypertension
    Have New York Heart Association class IV heart failure.
    Have lipoprotein apheresis within 90 days of screening, or planned lipoprotein apheresis during the study.
    Have severe renal failure
    Have a diagnosis of active nephrotic syndrome, or urine albumin-creatinine ratio (UACR) of =5000 mg/g at screening Visit 1.
    Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease, or any of these laboratory results as determined by the central laboratory at screening.

Additional Info

The first 3 doses of the study medicine will be 6 months apart. All of the following doses will be 1 year apart.

You will be randomly assigned to 1 of 2 groups. This means the group you will be in is chosen by chance. You will either be in the investigational medicine group or the placebo (no active medication) group. You and your study doctor will not know which study medicine you are getting.

Study participation is expected to last for at least 2 years but may last to 4 or 5 years.

Contact Info:

  • Teresa Juarez
  • juarez.teresa@scrippshealth.org
  • juarez.teresa@scrippshealth.org