Impact of Optimal Pharmacotherapy on Plasma Lipid Profile and Qualitative Features of Atherosclerotic Plaques in Very-high Cardiovascular Risk Patients With Established Atherosclerotic Cardiovascular Disease

PCSK9I-0621

Lipid accumulation, with mostly emphasized role of low-density lipoprotein cholesterol (LDL-C), is the pathogenetic cornerstone of atherosclerotic cardiovascular disease. Standard hypolipidemic therapy, based on statins and ezetimibe, does not always decrease LDL-C levels enough to achieve therapeutic goals. A novel and promising direction is inhibition of proprotein convertase subtilisin/kexin type 9 (PCSK9) in hepatocytes, subsequently reducing LDL-C receptor degradation and increasing intracellular LDL-C uptake. Aim of this study is to evaluate the effect of optimal hypolipidemic pharmacotherapy, including PCSK9 inhibitors and inclisiran, on plasma lipid profile and qualitative features of atherosclerotic plaques in very-high cardiovascular risk patients. This study enrolls patients with an established atherosclerotic cardiovascular disease, receiving PCSK9 inhibitors or inclisiran as add-on treatment to statins in maximally tolerated dose and/or ezetimibe. Effect of hypolipidemic pharmacotherapy is evaluated by analysis of plasma lipid profile parameter changes and qualitative features of atherosclerotic plaques using Near-Infrared Spectroscopy Intravascular Ultrasound Imaging (NIRS-IVUS) method. Results of the study would be sufficient for complementing evidence regarding therapeutic strategy in very-high cardiovascular risk patients.

2021-06-29

2023-02-17

2023-12-01

Active (not recruiting)

50

Inclusion Criteria: * Very high cardiovascular risk - documented atherosclerotic cardiovascular disease * On maximally tolerated statin and/or ezetimibe therapy for at least 1 month LDL-C treatment target \<1.4 mmol/l not achieved * Receiving PCSK9 inhibitor or inclisiran as add-on treatment to maximally tolerated statin dose and/or ezetimibe in the context of optimal pharmacotherapy * NIRS-IVUS performed (written informed consent for the procedure signed according to regulations in the hospital) * Available blood test results - plasma lipid profile * Patient agrees to participate in the study (signed informed consent) Exclusion Criteria: * Not fulfilling any of inclusion criteria

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2023-11-22