Last Update: Aug 03, 2025 Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia ClinicalTrials.gov Identifier: [NCT06858332](https://clinicaltrials.gov/ct2/show/NCT06858332) Novartis Reference Number:CTQJ230A1RU01 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study Description 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 Condition Atherosclerotic Cardiovascular Disease Overall Status Recruiting Number of Participants2382 Start Date Apr 15, 2025 Completion Date Sep 30, 2027 Gender All Age(s) 18 Years - 99 Years (Adult, Older Adult) ## Interventions Drug ### Alirocumab PCSK9 inhibitor Drug ### Atorvastatin 3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins) Drug ### Bezafibrate Fibrates Drug ### Ciprofibrate Fibrates Drug ### Evolocumab PCSK9 inhibitor Drug ### Ezetimibe Ezetimibe Drug ### Fenofibrate Fibrates Drug ### Inclisiran Small interfering RNA Drug ### Niacin Niacin Drug ### Rozuvastatin 3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins) Drug ### Simvastatin 3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins) ## 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. Russia #### Novartis Investigative Site Recruiting Ryazan,390039,Russia #### Novartis Investigative Site Recruiting Yekaterinburg,620144,Russia #### Novartis Investigative Site Recruiting Yekaterinburg,620137,Russia #### Novartis Investigative Site Recruiting Yakutsk,677013,Russia #### Novartis Investigative Site Recruiting Voronezh,394018,Russia #### Novartis Investigative Site Recruiting Vladivostok,690000,Russia #### Novartis Investigative Site Recruiting Vladimir,600020,Russia #### Novartis Investigative Site Recruiting Tyumen,625026,Russia #### Novartis Investigative Site Recruiting Tomsk,634009,Russia #### Novartis Investigative Site Recruiting Surgut,628403,Russia #### Novartis Investigative Site Recruiting Chelyabinsk,454048,Russia #### Novartis Investigative Site Recruiting Perm,614002,Russia #### Novartis Investigative Site Recruiting Omsk,644024,Russia #### Novartis Investigative Site Recruiting Moscow,125284,Russia #### Novartis Investigative Site Recruiting Moscow,121552,Russia #### Novartis Investigative Site Recruiting Moscow,119881,Russia #### Novartis Investigative Site Recruiting Krasnoyarsk,680022,Russia #### Novartis Investigative Site Recruiting Kemerovo,650002,Russia #### Novartis Investigative Site Recruiting Kaluga,248000,Russia #### Novartis Investigative Site Recruiting Chelyabinsk,454076,Russia ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ +41613241111](tel:+41613241111) Email: