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NCT Number: NCT06858332

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

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.

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Key information

Conditions

Atherosclerotic Cardiovascular Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Chelyabinsk, Russia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

atorvastatin

Drug

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

simvastatin

Drug

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

Rozuvastatin

Drug

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

ezetimibe

Drug

Ezetimibe

niacin

Drug

Niacin

Ciprofibrate

Drug

Fibrates

fenofibrate

Drug

Fibrates

Bezafibrate

Drug

Fibrates

Evolocumab

Drug

PCSK9 inhibitor

Alirocumab

Drug

PCSK9 inhibitor

Inclisiran

Drug

Small interfering RNA

Primary outcomes

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

    Time frame: Baseline

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

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

    Time frame: 24 months

    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

Secondary outcomes

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

    Time frame: Baseline

    Percentage of patients (%) with at least one CVD by Lp(a) level: ≤25 nmol/L, 25-75 nmol/L, 75-125 nmol/L, 125-188 nmol/L, 188-250 nmol/L, ≥250 nmol/L

    *CVD - Cardiovascular disease; ASCVD - Atherosclerotic cardiovascular disease

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

    Time frame: Baseline

    Percentage of ASCVD patients (%) by Lp(a) level: ≤25 nmol/L, 25-75 nmol/L, 75-125 nmol/L, 125-188 nmol/L, 188-250 nmol/L, ≥250 nmol/L

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

    Time frame: Baseline

    Age of patients at the time of the first ASCVD in different subgroups by Lp(a) level: ≤25 nmol/L, 25-75 nmol/L, 75-125 nmol/L, 125-188 nmol/L, 188-250 nmol/L, ≥250 nmol/L

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

    Time frame: Baseline

    Percentage of patients (%) with disability groups I, II, and III in different subgroups stratified by the Lp(a) level: ≤25 nmol/L, 25-75 nmol/L, 75-125 nmol/L, 125-188 nmol/L, 188-250 nmol/L, ≥250 nmol/L

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

    Time frame: Baseline

    Age of assignment of any disability group in different subgroups by the Lp(a) level: ≤25 nmol/L, 25-75 nmol/L, 75-125 nmol/L, 125-188 nmol/L, 188-250 nmol/L, ≥250 nmol/L

  6. Duration of temporary incapacity (sick leave) following the onset of CVE in different subgroups based on Lp(a) level

    Time frame: Baseline

    Duration of temporary incapacity (sick leave) following the onset of CVE (cardiovascular event) in different subgroups based on Lp(a) level: ≤25 nmol/L, 25-75 nmol/L, 75-125 nmol/L, 125-188 nmol/L, 188-250 nmol/L, ≥250 nmol/L

  7. Percentage of patients (%) without an official disability status who had to completely stop working after developing CVE in different subgroups based on Lp(a) level

    Time frame: Baseline

    Percentage of patients (%) without an official disability status who had to completely stop working after developing CVE (cardiovascular event) in different subgroups based on Lp(a) level: ≤25 nmol/L, 25-75 nmol/L, 75-125 nmol/L, 125-188 nmol/L, 188-250 nmol/L, ≥250 nmol/L

  8. Lp(a) distribution level by a ASCVD type

    Time frame: Baseline

    Percentage of patients with peripheral artery disease (PAD), ischemic stroke (IS), ischemic heart disease by the Lp(a) level*

    *≤25 nmol/L, 25-75 nmol/L, 75-125 nmol/L, 125-188 nmol/L, 188-250 nmol/L, ≥250 nmol/L

  9. Percentage (%) of ASCVD patients with elevated Lp(a) levels by gender and age (20-30, 31-40, 41-50, 51-60, 61-70, 71-80, 81-90 years)

    Time frame: Baseline

    Percentage (%) of ASCVD patients with elevated Lp(a) levels by gender and age (20-30, 31-40, 41-50, 51-60, 61-70, 71-80, 81-90 years)

  10. Percentage of patients (%) with hemodynamically significant coronary atherosclerosis (stenosis ≥50%) in different subgroups by the Lp(a) level

    Time frame: Baseline

    Percentage of patients (%) with hemodynamically significant coronary atherosclerosis (stenosis ≥50%) in different subgroups by the Lp(a) level ≤25 nmol/L, 25-75 nmol/L, 75-125 nmol/L, 125-188 nmol/L, 188-250 nmol/L, ≥250 nmol/L

  11. Percentage of ASCVD patients (%) with elevated Lp(a) levels in groups stratified by the number of coronary arteries with hemodynamically significant stenosis in patients with relevant available data

    Time frame: Baseline

    Percentage of ASCVD patients (%) with elevated Lp(a) levels in groups stratified by the number of coronary arteries with hemodynamically significant stenosis in patients with relevant available data

  12. Percentage (%) of ASCVD patients with an elevated Lp(a) level classified depending on the presence of multifocal atherosclerosis, ischemic heart disease, and peripheral artery disease

    Time frame: Baseline

    Percentage (%) of ASCVD patients with an elevated Lp(a) level classified depending on the presence of multifocal atherosclerosis, ischemic heart disease, and peripheral artery disease

  13. Percentage of ASCVD patients (%) with elevated Lp(a) levels classified into groups with different numbers of MI events

    Time frame: Baseline

    Percentage of ASCVD patients (%) with elevated Lp(a) levels classified into groups with different numbers of myocardial infarction (MI) events

  14. Percentage of ASCVD patients (%) with elevated Lp(a) levels classified into groups with different numbers of IS and TIA events

    Time frame: Baseline

    Percentage of ASCVD patients (%) with elevated Lp(a) levels classified into groups with different numbers of ischemic stroke (IS) and transient ischemic attack (TIA) events

  15. Percentage of ASCVD patients (%) with elevated Lp(a) levels classified into groups with different types of hospitalization (planned/emergency)

    Time frame: Baseline

    Percentage of ASCVD patients (%) with elevated Lp(a) levels classified into groups with different types of hospitalization (planned/emergency)

  16. Percentage (%) of ASCVD patients with elevated Lp(a) levels classified by the first cardiovascular event (CVE)

    Time frame: Baseline

    Percentage (%) of ASCVD patients with elevated Lp(a) levels classified by the first CVE (any of the following: myocardial infarction, ischemic stroke, transient ischemic attack, percutaneous coronary intervention, etc.)

  17. Percentage of ASCVD patients (%) with elevated Lp(a) levels by the PCI number (planned/emergency)

    Time frame: Baseline

    Percentage of ASCVD patients (%) with elevated Lp(a) levels by the percutaneous coronary intervention (PCI) number (planned/emergency)

  18. Percentage of patients (%) with the first CVE (MI or IS) (before the Screening visit) in different subgroups by the Lp(a) level

    Time frame: Baseline

    Percentage of patients (%) with the first CVE (MI or IS) (before the Screening visit) in different subgroups by the Lp(a) level ≤25 nmol/L, 25-75 nmol/L, 75-125 nmol/L, 125-188 nmol/L, 188-250 nmol/L, ≥250 nmol/L

  19. Percentage of patients (%) with several CVEs (MI or IS) (before the Screening visit) in different subgroups by the Lp(a) level

    Time frame: Baseline

    Percentage of patients (%) with several CVEs (MI or IS) (before the Screening visit) in different subgroups by the Lp(a) level ≤25 nmol/L, 25-75 nmol/L, 75-125 nmol/L, 125-188 nmol/L, 188-250 nmol/L, ≥250 nmol/L

  20. Number of recurrent CVEs in different subgroups by the Lp(a) level

    Time frame: Baseline

    Number of recurrent CVEs in different subgroups by the Lp(a) level ≤25 nmol/L, 25-75 nmol/L, 75-125 nmol/L, 125-188 nmol/L, 188-250 nmol/L, ≥250 nmol/L

  21. Percentage of patients (%) with unstable angina, manifestations of TIA, PCI, and CABG in medical history (before the Screening visit) in different subgroups by the Lp(a) level

    Time frame: Baseline

    Percentage of patients (%) with unstable angina, manifestations of transient ischemic attack (TIA), percutaneous coronary intervention (PCI), and coronary artery bypass grafting (CABG) in medical history (before the Screening visit) in different subgroups by the Lp(a) level ≤25 nmol/L, 25-75 nmol/L, 75-125 nmol/L, 125-188 nmol/L, 188-250 nmol/L, ≥250 nmol/L

  22. Percentage of patients (%) with multiple CVE, such as unstable angina, TIA, PCI, and CABG (before or after the index/screening visit), in different subgroups based on Lp(a) level

    Time frame: Baseline

    Percentage of patients (%) with multiple CVE, such as unstable angina, transient ischemic attack (TIA), percutaneous coronary intervention (PCI), and coronary artery bypass grafting (CABG) (before or after the index/screening visit), in different subgroups based on Lp(a) level ≤25 nmol/L, 25-75 nmol/L, 75-125 nmol/L, 125-188 nmol/L, 188-250 nmol/L, ≥250 nmol/L

  23. Percentage of patients (%) with severe CVE (MI, IS) (after the index/screening visit) based on the Lp(a) level in different subgroups

    Time frame: 3, 9, 12, 18, and 24 months

    Percentage of patients (%) with severe CVE (MI, IS) based on the Lp(a) level ≤25 nmol/L, 25-75 nmol/L, 75-125 nmol/L, 125-188 nmol/L, 188-250 nmol/L, ≥250 nmol/L at 3, 9, 12, 18, and 24 months

  24. Number of patients with recurrent CVEs (more than one event during the follow-up period) and the mean number of recurrent complications in the post-index visit period

    Time frame: 3, 9, 12, 18, and 24 months

    Number of patients with recurrent CVEs (more than one event during the follow-up period) and the mean number of recurrent complications at 3, 9, 12, 18, and 24 months

  25. Percentage of patients (%) with cardiovascular deaths after the index/screening visit in different subgroups by the Lp(a) level

    Time frame: 3, 9, 12, 18, and 24 months

    Percentage of patients (%) with cardiovascular deaths in different subgroups by the Lp(a) level ≤25 nmol/L, 25-75 nmol/L, 75-125 nmol/L, 125-188 nmol/L, 188-250 nmol/L, ≥250 nmol/L at 3, 9, 12, 18, and 24 months

  26. Percentage of patients who died after the index/screening visit in different subgroups by the Lp(a) level

    Time frame: 3, 9, 12, 18, and 24 months

    Percentage of patients who died in different subgroups by the Lp(a) level ≤25 nmol/L, 25-75 nmol/L, 75-125 nmol/L, 125-188 nmol/L, 188-250 nmol/L, ≥250 nmol/L at 3, 9, 12, 18, and 24 months

  27. Percentage of patients (%) who needed emergency medical care or visited a medical facility during the period following the index/screening visit in different subgroups by the Lp(a) level

    Time frame: 3, 9, 12, 18, and 24 months

    Percentage of patients (%) who needed emergency medical care or visited a medical facility in different subgroups by the Lp(a) level ≤25 nmol/L, 25-75 nmol/L, 75-125 nmol/L, 125-188 nmol/L, 188-250 nmol/L, ≥250 nmol/L at 3, 9, 12, 18, and 24 months

  28. Number of emergency visits or visits to a medical facility following the index/screening visit in various subgroups by the Lp(a) level

    Time frame: 3, 9, 12, 18, and 24 months

    Number of emergency visits or visits to a medical facility in various subgroups by the Lp(a) level ≤25 nmol/L, 25-75 nmol/L, 75-125 nmol/L, 125-188 nmol/L, 188-250 nmol/L, ≥250 nmol/L at 3, 9, 12, 18, and 24 months

  29. Percentage of ASCVD patients (%) who achieved the target LDL-C level with the current lipid-lowering therapy

    Time frame: 3, 9, 12, 18, and 24 months

    Percentage of ASCVD patients (%) who achieved the target LDL-C level with the current lipid-lowering therapy

  30. Percentage of ASCVD patients (%) receiving lipid-lowering therapy, who experienced a change in Lp(a) levels

    Time frame: 3, 9, 12, 18, and 24 months

    Percentage of ASCVD patients (%) receiving lipid-lowering therapy, who experienced a change in Lp(a) levels

  31. Number of first-degree relatives (%) of patients with Lp(a) ≥125 nmol/

    Time frame: Baseline

    Number of first-degree relatives (%) of patients with Lp(a) ≥125 nmol/L

  32. Difference between groups in the number of relatives (%) with CVD complications during the 2-year observation period

    Time frame: 24 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Acronym: STaRT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 5, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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