Last Update: Jun 29, 2025
Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia
ClinicalTrials.gov Identifier:
Novartis Reference Number:CTQJ230A1RU01
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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. This study will consist of several phases (consecutive stages):

Phase I: a cross-sectional study of Lp(a) level with ASCVD patients

Phase II:

* A non-interventional, prospective, cohort study with the phase I patients
* A cross-sectional study of Lp(a) levels with relatives of phase I patients
* A non-interventional, prospective, cohort study with patients' relatives

Atherosclerotic Cardiovascular Disease
Recruiting
2382
Apr 15, 2025
Sep 30, 2027
All
18 Years - 99 Years (Adult, Older Adult)

Interventions

Drug

Alirocumab

PCSK9 inhibitor
Drug

Atorvastatin

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

Bezafibrate

Fibrates
Drug

Ciprofibrate

Fibrates
Drug

Evolocumab

PCSK9 inhibitor
Drug

Ezetimibe

Ezetimibe
Drug

Fenofibrate

Fibrates
Drug

Inclisiran

Small interfering RNA
Drug

Niacin

Niacin
Drug

Rozuvastatin

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

Simvastatin

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

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.

Novartis Investigative Site

Recruiting

Tomsk,634009,Russian Federation

Novartis Investigative Site

Recruiting

Krasnoyarsk,680022,Russian Federation

Novartis Investigative Site

Recruiting

Chelyabinsk,454048,Russian Federation

Novartis Investigative Site

Recruiting

Tyumen,625026,Russian Federation

Novartis Investigative Site

Recruiting

Moscow,119881,Russian Federation

Novartis Investigative Site

Recruiting

Chelyabinsk,454076,Russian Federation

Novartis Investigative Site

Recruiting

Vladimir,600020,Russian Federation

Novartis Investigative Site

Recruiting

Omsk,644024,Russian Federation

Novartis Investigative Site

Recruiting

Ekaterinburg,620137,Russian Federation

Novartis Investigative Site

Recruiting

Vladivostok,690000,Russian Federation

Novartis Investigative Site

Recruiting

Perm,614002,Russian Federation

Novartis Investigative Site

Recruiting

Ekaterinburg,620144,Russian Federation

Novartis Investigative Site

Recruiting

Yakutsk,677013,Russian Federation

Novartis Investigative Site

Recruiting

Ryazan,390039,Russian Federation

Novartis Investigative Site

Recruiting

Kaluga,248000,Russian Federation

Novartis Investigative Site

Recruiting

Surgut,628403,Russian Federation

Novartis Investigative Site

Recruiting

Kemerovo,650002,Russian Federation

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