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

NCT06858332 | Recruiting

• 1 other identifier: CTQJ230A1RU01
• Study Type: observational
• Target: 2,382
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Atherosclerotic Cardiovascular Disease

Keywords

lipoprotein(a),; ASCVD,; cardiovascular disease,; CVD

Outcome Measures

Primary Outcomes (2)

• Percentage of patients (%) with Lp(a) ≥125 nmol/L

  Percentage of patients (%) with Lp(a) ≥125 nmol/L at baseline

  Baseline

• The difference in the number of patients with cardiovascular events (%) between the groups

  The difference in the number of patients (%) with new cardiovascular events between the groups of patients with elevated Lp(a) ≥125 nmol/L and Lp(a) \<125 nmol/L

  24 months

Secondary Outcomes (32)

• Percentage of patients (%) with at least one CVD, and ASCVD number in different subgroups stratified by Lp(a) level

  Baseline

• Percentage of ASCVD patients (%) in accordance with the Lp(a) level

  Baseline

• Age of patients at the time of the first ASCVD in different subgroups in accordance with the Lp(a) level

  Baseline

• Percentage of patients (%) with disability groups I, II, and III in different subgroups stratified by the Lp(a) level

  Baseline

• Age of assignment of any disability group in different subgroups by the Lp(a) level

  Baseline

Study Arms (2)

ASCVD patients

Patients aged 18 and above with a history of ASCVD including peripheral arterial revascularization

Drug: Atorvastatin; Drug: Simvastatin; Drug: Rozuvastatin; Drug: Ezetimibe; Drug: Niacin; Drug: Ciprofibrate; Drug: Fenofibrate; Drug: Bezafibrate; Drug: Evolocumab; Drug: Alirocumab; Drug: Inclisiran

Relatives of the ASCVD patients

A first-degree relative of the ASCVD patient (patient's parents and children) with Lp(a) ≥125 nmol/L.

Drug: Atorvastatin; Drug: Simvastatin; Drug: Rozuvastatin; Drug: Ezetimibe; Drug: Niacin; Drug: Ciprofibrate; Drug: Fenofibrate; Drug: Bezafibrate; Drug: Evolocumab; Drug: Alirocumab; Drug: Inclisiran

Interventions

Atorvastatin DRUG

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

ASCVD patients; Relatives of the ASCVD patients

Simvastatin DRUG

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

ASCVD patients; Relatives of the ASCVD patients

Rozuvastatin DRUG

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

ASCVD patients; Relatives of the ASCVD patients

Ezetimibe DRUG

Ezetimibe

ASCVD patients; Relatives of the ASCVD patients

Niacin DRUG

Niacin

ASCVD patients; Relatives of the ASCVD patients

Ciprofibrate DRUG

Fibrates

ASCVD patients; Relatives of the ASCVD patients

Fenofibrate DRUG

Fibrates

ASCVD patients; Relatives of the ASCVD patients

Bezafibrate DRUG

Fibrates

ASCVD patients; Relatives of the ASCVD patients

Evolocumab DRUG

PCSK9 inhibitor

ASCVD patients; Relatives of the ASCVD patients

Alirocumab DRUG

PCSK9 inhibitor

ASCVD patients; Relatives of the ASCVD patients

Inclisiran DRUG

Small interfering RNA

ASCVD patients; Relatives of the ASCVD patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with the history of atherosclerotic cardiovascular disease (ASCVD). First-degree relatives of the ASCVD patient (patient's parents and children) with Lp(a) ≥125 nmol/L

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).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (20)

Novartis Investigative Site

Chelyabinsk, 454048, Russia

RECRUITING

Novartis Investigative Site

Chelyabinsk, 454076, Russia

RECRUITING

Novartis Investigative Site

Kaluga, 248000, Russia

RECRUITING

Novartis Investigative Site

Kemerovo, 650002, Russia

RECRUITING

Novartis Investigative Site

Krasnoyarsk, 680022, Russia

RECRUITING

Novartis Investigative Site

Moscow, 119881, Russia

RECRUITING

Novartis Investigative Site

Moscow, 121552, Russia

RECRUITING

Novartis Investigative Site

Moscow, 125284, Russia

RECRUITING

Novartis Investigative Site

Omsk, 644024, Russia

RECRUITING

Novartis Investigative Site

Perm, 614002, Russia

RECRUITING

Novartis Investigative Site

Ryazan, 390039, Russia

RECRUITING

Novartis Investigative Site

Surgut, 628403, Russia

RECRUITING

Novartis Investigative Site

Tomsk, 634009, Russia

RECRUITING

Novartis Investigative Site

Tyumen, 625026, Russia

RECRUITING

Novartis Investigative Site

Vladimir, 600020, Russia

RECRUITING

Novartis Investigative Site

Vladivostok, 690000, Russia

RECRUITING

Novartis Investigative Site

Voronezh, 394018, Russia

RECRUITING

Novartis Investigative Site

Yakutsk, 677013, Russia

RECRUITING

Novartis Investigative Site

Yekaterinburg, 620137, Russia

RECRUITING

Novartis Investigative Site

Yekaterinburg, 620144, Russia

RECRUITING

MeSH Terms

Conditions

Atherosclerosis; Cardiovascular Diseases

Interventions

Atorvastatin; Simvastatin; Ezetimibe; Niacin; ciprofibrate; Fenofibrate; Bezafibrate; evolocumab; alirocumab; ALN-PCS

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Azetidines; Azetines; Nicotinic Acids; Acids, Heterocyclic; Pyridines; Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Phenols; Ketones; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Chlorobenzoates

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: March 5, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (20)