Lipoprotein(a) levels in adults with atherosclerotic cardiovascular disease in Russia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational project begins with a cross-sectional measurement of Lp(a) in adults with documented atherosclerotic cardiovascular disease at selected Russian sites. Subsequent prospective cohort phases will follow those patients and include their relatives, with cross-sectional Lp(a) testing for family members and ongoing collection of clinical events and medication use. The study is non-interventional and will record use of common lipid-lowering drugs such as statins, ezetimibe, and niacin while excluding participants with prior Lp(a)-lowering procedures or certain therapies. Collected data will be used to describe Lp(a) distribution in this population and to analyze links between elevated Lp(a) and cardiovascular risk.

Why it matters

Who can join: the full rules

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.

Where it's running

• Novartis Investigative Site
  Chelyabinsk, Russia Recruiting
• Novartis Investigative Site
  Chelyabinsk, Russia Recruiting
• Novartis Investigative Site
  Kaluga, Russia Recruiting
• Novartis Investigative Site
  Kemerovo, Russia Recruiting
• Novartis Investigative Site
  Krasnoyarsk, Russia Recruiting
• Novartis Investigative Site
  Moscow, Russia Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.