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

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.

Study Overview

• Status: Recruiting
• Conditions: Atherosclerotic Cardiovascular Disease
• Intervention / Treatment: Drug: Ezetimibe; Drug: Atorvastatin; Drug: Simvastatin; Drug: Rozuvastatin; Drug: Niacin; Drug: Ciprofibrate; Drug: Fenofibrate; Drug: Bezafibrate; Drug: Evolocumab; Drug: Alirocumab; Drug: Inclisiran

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 2382

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Study Locations

• Russian Federation
  • Chelyabinsk, Russian Federation, 454048
    • Recruiting
    • Novartis Investigative Site
  • Chelyabinsk, Russian Federation, 454076
    • Recruiting
    • Novartis Investigative Site
  • Ekaterinburg, Russian Federation, 620137
    • Recruiting
    • Novartis Investigative Site
  • Ekaterinburg, Russian Federation, 620144
    • Recruiting
    • Novartis Investigative Site
  • Kaluga, Russian Federation, 248000
    • Recruiting
    • Novartis Investigative Site
  • Kemerovo, Russian Federation, 650002
    • Recruiting
    • Novartis Investigative Site
  • Krasnoyarsk, Russian Federation, 680022
    • Recruiting
    • Novartis Investigative Site
  • Moscow, Russian Federation, 125284
    • Recruiting
    • Novartis Investigative Site
  • Moscow, Russian Federation, 119881
    • Recruiting
    • Novartis Investigative Site
  • Moscow, Russian Federation, 121552
    • Recruiting
    • Novartis Investigative Site
  • Omsk, Russian Federation, 644024
    • Recruiting
    • Novartis Investigative Site
  • Perm, Russian Federation, 614002
    • Recruiting
    • Novartis Investigative Site
  • Ryazan, Russian Federation, 390039
    • Recruiting
    • Novartis Investigative Site
  • Surgut, Russian Federation, 628403
    • Recruiting
    • Novartis Investigative Site
  • Tomsk, Russian Federation, 634009
    • Recruiting
    • Novartis Investigative Site
  • Tyumen, Russian Federation, 625026
    • Recruiting
    • Novartis Investigative Site
  • Vladimir, Russian Federation, 600020
    • Recruiting
    • Novartis Investigative Site
  • Vladivostok, Russian Federation, 690000
    • Recruiting
    • Novartis Investigative Site
  • Voronezh, Russian Federation, 394018
    • Recruiting
    • Novartis Investigative Site
  • Yakutsk, Russian Federation, 677013
    • Recruiting
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ASCVD patients; Patients aged 18 and above with a history of ASCVD including peripheral arterial revascularization	Drug: Ezetimibe; Ezetimibe; Drug: Atorvastatin; 3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins); Drug: Simvastatin; 3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins); Drug: Rozuvastatin; 3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins); Drug: Niacin; Niacin; Drug: Ciprofibrate; Fibrates; Drug: Fenofibrate; Fibrates; Drug: Bezafibrate; Fibrates; Drug: Evolocumab; PCSK9 inhibitor; Drug: Alirocumab; PCSK9 inhibitor; Drug: Inclisiran; Small interfering RNA
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: Ezetimibe; Ezetimibe; Drug: Atorvastatin; 3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins); Drug: Simvastatin; 3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins); Drug: Rozuvastatin; 3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins); Drug: Niacin; Niacin; Drug: Ciprofibrate; Fibrates; Drug: Fenofibrate; Fibrates; Drug: Bezafibrate; Fibrates; Drug: Evolocumab; PCSK9 inhibitor; Drug: Alirocumab; PCSK9 inhibitor; Drug: Inclisiran; Small interfering RNA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients (%) with at least one CVD, and ASCVD number in different subgroups stratified by Lp(a) level	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	Baseline
Percentage of ASCVD patients (%) in accordance with the Lp(a) level	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	Baseline
Age of patients at the time of the first ASCVD in different subgroups in accordance with the Lp(a) level	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	Baseline
Percentage of patients (%) with disability groups I, II, and III in different subgroups stratified by the Lp(a) level	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	Baseline
Age of assignment of any disability group in different subgroups by the Lp(a) level	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	Baseline
Duration of temporary incapacity (sick leave) following the onset of CVE in different subgroups based on Lp(a) level	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	Baseline
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	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	Baseline
Lp(a) distribution level by a ASCVD type	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	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)	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)	Baseline
Percentage of patients (%) with hemodynamically significant coronary atherosclerosis (stenosis ≥50%) in different subgroups by the Lp(a) level	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	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	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	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	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	Baseline
Percentage of ASCVD patients (%) with elevated Lp(a) levels classified into groups with different numbers of MI events	Percentage of ASCVD patients (%) with elevated Lp(a) levels classified into groups with different numbers of myocardial infarction (MI) events	Baseline
Percentage of ASCVD patients (%) with elevated Lp(a) levels classified into groups with different numbers of IS and TIA events	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	Baseline
Percentage of ASCVD patients (%) with elevated Lp(a) levels classified into groups with different types of hospitalization (planned/emergency)	Percentage of ASCVD patients (%) with elevated Lp(a) levels classified into groups with different types of hospitalization (planned/emergency)	Baseline
Percentage (%) of ASCVD patients with elevated Lp(a) levels classified by the first cardiovascular event (CVE)	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.)	Baseline
Percentage of ASCVD patients (%) with elevated Lp(a) levels by the PCI number (planned/emergency)	Percentage of ASCVD patients (%) with elevated Lp(a) levels by the percutaneous coronary intervention (PCI) number (planned/emergency)	Baseline
Percentage of patients (%) with the first CVE (MI or IS) (before the Screening visit) in different subgroups by the Lp(a) level	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	Baseline
Percentage of patients (%) with several CVEs (MI or IS) (before the Screening visit) in different subgroups by the Lp(a) level	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	Baseline
Number of recurrent CVEs in different subgroups by the Lp(a) level	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	Baseline
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	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	Baseline
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	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	Baseline
Percentage of patients (%) with severe CVE (MI, IS) (after the index/screening visit) based on the Lp(a) level in different subgroups	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	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 in the post-index visit period	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	3, 9, 12, 18, and 24 months
Percentage of patients (%) with cardiovascular deaths after the index/screening visit in different subgroups by the Lp(a) level	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	3, 9, 12, 18, and 24 months
Percentage of patients who died after the index/screening visit in different subgroups by the Lp(a) level	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	3, 9, 12, 18, and 24 months
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	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	3, 9, 12, 18, and 24 months
Number of emergency visits or visits to a medical facility following the index/screening visit in various subgroups by the Lp(a) level	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	3, 9, 12, 18, and 24 months
Percentage of ASCVD patients (%) who achieved the target LDL-C level with the current lipid-lowering therapy	Percentage of ASCVD patients (%) who achieved the target LDL-C level with the current lipid-lowering therapy	3, 9, 12, 18, and 24 months
Percentage of ASCVD patients (%) receiving lipid-lowering therapy, who experienced a change in Lp(a) levels	Percentage of ASCVD patients (%) receiving lipid-lowering therapy, who experienced a change in Lp(a) levels	3, 9, 12, 18, and 24 months
Number of first-degree relatives (%) of patients with Lp(a) ≥125 nmol/	Number of first-degree relatives (%) of patients with Lp(a) ≥125 nmol/L	Baseline
Difference between groups in the number of relatives (%) with CVD complications during the 2-year observation period	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	24 months

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: February 18, 2025
• First Submitted That Met QC Criteria: March 3, 2025
• First Posted (Actual): March 5, 2025

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: CVD; lipoprotein(a),; ASCVD,; cardiovascular disease,
• Additional Relevant MeSH Terms: Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases; Atherosclerosis; PCSK9 Inhibitors; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Antimetabolites; Serine Proteinase Inhibitors; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Ezetimibe; Alirocumab; Bezafibrate; Simvastatin; Evolocumab; Fenofibrate; Ciprofibrate
• Other Study ID Numbers: CTQJ230A1RU01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO