Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Elevated Lipoprotein(a)
• Age: Between 18 Year(s) - 99 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Have the disease characteristics of either:
     1. Individuals 18 years of age or older with established ASCVD, with an event or revascularization = 90 days. Established ASCVD with history of an event or revascularization is defined as meeting at least one of the following:
        • Coronary artery disease
          • ST or non-ST elevation MI, or
          • coronary artery bypass grafting (CABG), or
          • percutaneous coronary revascularization.
        • Cerebrovascular disease
          • ischemic stroke
          Does not include transient ischemic attack, hemorrhagic or embolic stroke, or
          • carotid stenting or endarterectomy.
        • Peripheral arterial disease, lower extremity
          • amputation due to atherosclerotic disease, or
          • peripheral revascularization procedure, for example, stenting or surgical revascularization.
     OR
     2. Individuals 55 years of age or older who are at risk for a first CV event with the required number of risk factors listed in this table at screening Visit 1.
        • Participants must have 1 or more of these risk factors:
          • Documented CAD or PAD
          • Known familial hypercholesterolemia
        • Participants must have 3 or more of these risk factors:
          • Older age; individuals assigned female at birth, 70 years of age or older, assigned male at birth 65 years of age or older
          • Current tobacco use
          • Hypertension
          • Kidney disease
          • Diabetes
          • Family history of premature ASCVD
          • Hyperlipidemia
     3. If an individual is taking lipid-lowering medications, then
        • statins or prescription strength niacin should be stable 4 weeks prior to Visit 2, and
        • PCSK9 inhibitors should be stable 8 weeks prior to Visit 2.
     4. Are reliable and willing to make themselves available for the duration of the study, attend required study visits, and are willing and able to follow study procedures as required.
  
  

You may not be eligible for this study if the following are true:

• 1. Have had a major CV event or surgery, such as MI, stroke, or coronary or peripheral revascularization, < 90 days
  2. Have uncontrolled hypertension at screening Visit 1 of
     • SBP =180 mm Hg or
     • DBP =110 mm Hg.
  3. Have New York Heart Association class IV heart failure.
  4. Within 5 years of screening Visit 1, have a known coronary artery calcium score of 0, or if the individual has more than one score during this time, 0 is the highest value.
  5. Have lipoprotein apheresis within 90 days of screening, or planned lipoprotein apheresis during the study.