Clinical trial NCT06858332: Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia
Official title: Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atherosclerotic Cardiovascular Disease
Keywords: lipoprotein(a),
ASCVD,
cardiovascular disease,
CVD
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2025-03-05
Enrollment: 2382
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

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.

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