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

Обзор

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.

Подробное описание

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

Вмешательства

• Препарат Atorvastatin
  3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins)
• Препарат Simvastatin
  3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins)
• Препарат Rozuvastatin
  3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins)
• Препарат Ezetimibe
  Ezetimibe
• Препарат Niacin
  Niacin
• Препарат Ciprofibrate
  Fibrates
• Препарат Fenofibrate
  Fibrates
• Препарат Bezafibrate
  Fibrates
• Препарат Evolocumab
  PCSK9 inhibitor
• Препарат Alirocumab
  PCSK9 inhibitor

Первичные конечные точки

• Percentage of patients (%) with Lp(a) ≥125 nmol/L [Срок оценки: Baseline]
• The difference in the number of patients with cardiovascular events (%) between the groups [Срок оценки: 24 months]

Вторичные конечные точки (12)

• Percentage of patients (%) with at least one CVD, and ASCVD number in different subgroups stratified by Lp(a) level [Срок оценки: Baseline]
• Percentage of ASCVD patients (%) in accordance with the Lp(a) level [Срок оценки: Baseline]
• Age of patients at the time of the first ASCVD in different subgroups in accordance with the Lp(a) level [Срок оценки: Baseline]
• Percentage of patients (%) with disability groups I, II, and III in different subgroups stratified by the Lp(a) level [Срок оценки: Baseline]
• Age of assignment of any disability group in different subgroups by the Lp(a) level [Срок оценки: Baseline]
• Duration of temporary incapacity (sick leave) following the onset of CVE in different subgroups based on Lp(a) level [Срок оценки: 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 [Срок оценки: Baseline]
• Lp(a) distribution level by a ASCVD type [Срок оценки: 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) [Срок оценки: Baseline]
• Percentage of patients (%) with hemodynamically significant coronary atherosclerosis (stenosis ≥50%) in different subgroups by the Lp(a) level [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Россия · 20 центров

• Novartis Investigative Site — Chelyabinsk
• Novartis Investigative Site — Chelyabinsk
• Novartis Investigative Site — Kaluga
• Novartis Investigative Site — Kemerovo
• Novartis Investigative Site — Krasnoyarsk
• Novartis Investigative Site — Moscow
• Novartis Investigative Site — Moscow
• Novartis Investigative Site — Moscow
• … и ещё 12 центров

Идентификаторы

NCT: NCT06858332 · CTQJ230A1RU01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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