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

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

We will measure Lipoprotein(a) levels in adults with atherosclerotic cardiovascular disease in Russia and their relatives to see how common high levels are and whether they link to higher heart and stroke risk.

Quick facts

• Study type: Observational
• Enrollment: 2382 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Novartis (Industry-sponsored)
• Locations: 20 sites (Chelyabinsk and 19 other locations)
• Trial ID: NCT06858332 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (age ≥18) in Russia with documented ASCVD events or revascularization procedures within the specified timeframe who can give informed consent and are not on Lp(a)-lowering therapies.

Not a fit: People without ASCVD, those under 18, or individuals already treated with Lp(a)-lowering procedures or drugs are unlikely to receive direct benefit from participation.

Why it matters

Potential benefit: If successful, the results could help identify people with high Lp(a) who may need closer monitoring or targeted treatment to lower cardiovascular risk.

How similar studies have performed: Large observational studies have previously linked elevated Lp(a) to higher cardiovascular risk, though population-specific data for Russia are limited.

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.

Where this trial is running

Chelyabinsk and 19 other locations

• 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)
• Novartis Investigative Site — Moscow, Russia (Recruiting)
• Novartis Investigative Site — Moscow, Russia (Recruiting)
• Novartis Investigative Site — Omsk, Russia (Recruiting)
• Novartis Investigative Site — Perm, Russia (Recruiting)
• Novartis Investigative Site — Ryazan, Russia (Recruiting)
• Novartis Investigative Site — Surgut, Russia (Recruiting)
• Novartis Investigative Site — Tomsk, Russia (Recruiting)
• Novartis Investigative Site — Tyumen, Russia (Recruiting)
• Novartis Investigative Site — Vladimir, Russia (Recruiting)
• Novartis Investigative Site — Vladivostok, Russia (Recruiting)
• Novartis Investigative Site — Voronezh, Russia (Recruiting)
• Novartis Investigative Site — Yakutsk, Russia (Recruiting)
• Novartis Investigative Site — Yekaterinburg, Russia (Recruiting)
• Novartis Investigative Site — Yekaterinburg, Russia (Recruiting)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions Atherosclerotic Cardiovascular Disease; lipoprotein,; ASCVD,; cardiovascular disease,; CVD