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

Recruiting now

Conditions studied: Atherosclerotic Cardiovascular Disease

In brief

This study has the purpose to answer how the Lipoprotein(a) (Lp(a)) level is distributed among Atherosclerotic cardiovascular disease (ASCVD) patients in Russia, and what is the connection between elevated levels of this parameter and the cardiovascular disease (CVD) risk.

Key facts

Study ID

NCT06858332

Run by

Novartis Pharmaceuticals

People needed

2382

Starts

2025-04-15

Expected to finish

2027-09-30

Last updated by the study team

2025-08-03

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent (signed and dated).
• Males and females aged ≥18 years.
• 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).

You may not qualify if…

• Acute infectious and inflammatory diseases, such as COVID-19, in the month leading up to the Screening visit.
• 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.
• Participation in any interventional clinical study with investigational or marketed medicinal products at the time of enrollment.
• Participation in other real-world clinical studies.
• 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 is running

• Novartis Investigative Site — Chelyabinsk, Russia (enrolling)
• Novartis Investigative Site — Chelyabinsk, Russia (enrolling)
• Novartis Investigative Site — Kaluga, Russia (enrolling)
• Novartis Investigative Site — Kemerovo, Russia (enrolling)
• Novartis Investigative Site — Krasnoyarsk, Russia (enrolling)
• Novartis Investigative Site — Moscow, Russia (enrolling)
• Novartis Investigative Site — Moscow, Russia (enrolling)
• Novartis Investigative Site — Moscow, Russia (enrolling)
• Novartis Investigative Site — Omsk, Russia (enrolling)
• Novartis Investigative Site — Perm, Russia (enrolling)
• Novartis Investigative Site — Ryazan, Russia (enrolling)
• Novartis Investigative Site — Surgut, Russia (enrolling)
• Novartis Investigative Site — Tomsk, Russia (enrolling)
• Novartis Investigative Site — Tyumen, Russia (enrolling)
• Novartis Investigative Site — Vladimir, Russia (enrolling)
• Novartis Investigative Site — Vladivostok, Russia (enrolling)
• Novartis Investigative Site — Voronezh, Russia (enrolling)
• Novartis Investigative Site — Yakutsk, Russia (enrolling)
• Novartis Investigative Site — Yekaterinburg, Russia (enrolling)
• Novartis Investigative Site — Yekaterinburg, Russia (enrolling)

Full record on ClinicalTrials.gov

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