Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia

Launched by NOVARTIS PHARMACEUTICALS · Mar 3, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the levels of a substance called Lipoprotein(a) or Lp(a) in patients with a type of heart disease known as atherosclerotic cardiovascular disease (ASCVD) in Russia. The study aims to understand how common high Lp(a) levels are among these patients and how these levels might be linked to the risk of heart problems. This research is important because it could help doctors better understand heart disease and how to treat it.

To participate in this study, individuals must be at least 18 years old and have a history of specific heart conditions, such as a heart attack or certain types of surgeries related to heart disease. Participants will need to sign a consent form agreeing to join the study. It's important to note that individuals with recent infections, certain kidney or liver diseases, or those who have received treatments to lower Lp(a) levels in the past month are not eligible to take part. If you qualify and choose to participate, you will help contribute valuable information that could improve care for people with heart disease in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Written informed consent (signed and dated).
• • 2. Males and females aged ≥18 years.
• 3. Presence of one of the following ASCVDs for at least 3 months within the 2 years prior to signing the informed consent to participate in this study:
• • history of MI;
• • history of IS and/or TIA;
• • IHD confirmed by coronary angiography (stenosis ≥50%);
• • any revascularization surgery (emergency or planned), including CABG, PCI, carotid endarterectomy or carotid/intracranial stenting;
• • peripheral artery disease (intermittent claudication with ankle-brachial index ≤0.90 and/or lower limb amputation or revascularization in case of lower limb ischemia).
• Exclusion Criteria:
• • 1. Acute infectious and inflammatory diseases, such as COVID-19, in the month leading up to the Screening visit.
• • 2. Lp(a)-lowering therapy/methods (Lp(a) apheresis with PCSK9 inhibitors, inclisiran prior to the Screening visit) in the medical history before the Screening visit.
• • 3. Participation in any interventional clinical study with investigational or marketed medicinal products at the time of enrollment.
• • 4. Participation in other real-world clinical studies.
• • 5. Stages 4 and 5 of chronic kidney disease (glomerular filtration rate CKD-EPI \<30 mL/min/1.73 m2) and/or hepatic disease (total bilirubin: 2 × ULN).
• • Other protocol-defined inclusion/exclusion criteria may apply.