Recruiting NCT06858332
Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Atorvastatin, Simvastatin, Rozuvastatin, Ezetimibe.
- Who it may be relevant to
- Registry conditions: Atherosclerotic Cardiovascular Disease. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- 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 Ezetimibe
Ezetimibe - Drug Niacin
Niacin - Drug Ciprofibrate
Fibrates - Drug Fenofibrate
Fibrates - Drug Bezafibrate
Fibrates - Drug Evolocumab
PCSK9 inhibitor - Drug Alirocumab
PCSK9 inhibitor
Primary outcome measures
- Percentage of patients (%) with Lp(a) ≥125 nmol/L [Time frame: Baseline]
- The difference in the number of patients with cardiovascular events (%) between the groups [Time frame: 24 months]
Secondary outcome measures (12)
- Percentage of patients (%) with at least one CVD, and ASCVD number in different subgroups stratified by Lp(a) level [Time frame: Baseline]
- Percentage of ASCVD patients (%) in accordance with the Lp(a) level [Time frame: Baseline]
- Age of patients at the time of the first ASCVD in different subgroups in accordance with 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 [Time frame: Baseline]
- Age of assignment of any disability group in different subgroups by the Lp(a) level [Time frame: Baseline]
- Duration of temporary incapacity (sick leave) following the onset of 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 in different subgroups based on Lp(a) level [Time frame: Baseline]
- Lp(a) distribution level by a ASCVD type [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) [Time frame: Baseline]
- Percentage of patients (%) with hemodynamically significant coronary atherosclerosis (stenosis ≥50%) in different subgroups by the Lp(a) level [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 [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 [Time frame: Baseline]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Russia · 20 centers
- 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
- … and 12 more centers
Identifiers
NCT: NCT06858332 · CTQJ230A1RU01