RecruitingNCT06858332

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


Sponsor

Novartis Pharmaceuticals

Enrollment

2,382 participants

Start Date

Apr 15, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria8

  • 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).

Exclusion Criteria5

  • 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).

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Interventions

DRUGAtorvastatin

3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins)

DRUGSimvastatin

3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins)

DRUGRozuvastatin

3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins)

DRUGEzetimibe

Ezetimibe

DRUGNiacin

Niacin

DRUGCiprofibrate

Fibrates

DRUGFenofibrate

Fibrates

DRUGBezafibrate

Fibrates

DRUGEvolocumab

PCSK9 inhibitor

DRUGAlirocumab

PCSK9 inhibitor

DRUGInclisiran

Small interfering RNA


Locations(20)

Novartis Investigative Site

Chelyabinsk, Russia

Novartis Investigative Site

Chelyabinsk, Russia

Novartis Investigative Site

Kaluga, Russia

Novartis Investigative Site

Kemerovo, Russia

Novartis Investigative Site

Krasnoyarsk, Russia

Novartis Investigative Site

Moscow, Russia

Novartis Investigative Site

Moscow, Russia

Novartis Investigative Site

Moscow, Russia

Novartis Investigative Site

Omsk, Russia

Novartis Investigative Site

Perm, Russia

Novartis Investigative Site

Ryazan, Russia

Novartis Investigative Site

Surgut, Russia

Novartis Investigative Site

Tomsk, Russia

Novartis Investigative Site

Tyumen, Russia

Novartis Investigative Site

Vladimir, Russia

Novartis Investigative Site

Vladivostok, Russia

Novartis Investigative Site

Voronezh, Russia

Novartis Investigative Site

Yakutsk, Russia

Novartis Investigative Site

Yekaterinburg, Russia

Novartis Investigative Site

Yekaterinburg, Russia

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NCT06858332


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