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
Study Type
OBSERVATIONAL
Enrollment
2,382
3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins)
3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins)
3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins)
Novartis Investigative Site
Chelyabinsk, Russia
RECRUITINGPercentage of patients (%) with Lp(a) ≥125 nmol/L
Percentage of patients (%) with Lp(a) ≥125 nmol/L at baseline
Time frame: 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
Time frame: 24 months
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
Time frame: 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
Time frame: 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
Time frame: 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
Novartis Pharmaceuticals
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Ezetimibe
Niacin
Fibrates
Fibrates
Fibrates
PCSK9 inhibitor
PCSK9 inhibitor
Small interfering RNA
Novartis Investigative Site
Chelyabinsk, Russia
RECRUITINGNovartis Investigative Site
Kaluga, Russia
RECRUITINGNovartis Investigative Site
Kemerovo, Russia
RECRUITINGNovartis Investigative Site
Krasnoyarsk, Russia
RECRUITINGNovartis Investigative Site
Moscow, Russia
RECRUITINGNovartis Investigative Site
Moscow, Russia
RECRUITINGNovartis Investigative Site
Moscow, Russia
RECRUITINGNovartis Investigative Site
Omsk, Russia
RECRUITINGNovartis Investigative Site
Perm, Russia
RECRUITING...and 10 more locations
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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)
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 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
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
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 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.)
Time frame: 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)
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
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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
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 (%) 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
Time frame: 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
Time frame: 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
Time frame: 24 months