Impact of Optimal Pharmacotherapy on Lipid Profile and Qualitative Features of Atherosclerotic Plaques

NCT05639218 | Unknown

• 1 other identifier: PCSK9I-0621
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atherosclerotic Cardiovascular Disease

Keywords

Atherosclerosis; PCSK9; Inclisiran; NIRS-IVUS; LDL-C

Outcome Measures

Primary Outcomes (2)

• LDL-C level

  Plasma LDL-C level changes in patients receiving PCSK9 inhibitors or inclisiran

  15 months

• Qualitative features of atherosclerotic plaques

  Changes in qualitative features of atherosclerotic plaques assessed by NIRS-IVUS investigation

  15 months

Interventions

Inclisiran DRUG

Patients are receiving PCSK9 inhibitors or inclisiran in the context of optimal hypolipidemic pharmacotherapy

Also known as: PCSK9 inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study enrolled very high cardiovascular risk patients with established atherosclerotic cardiovascular disease, who receive PCSK9 inhibitors or inclisiran as add-on treatment to maximally tolerated statin dose and/or ezetimibe in the context of optimal pharmacotherapy, and in whom NIRS-IVUS has been performed in the Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital.

You may qualify if:

• 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)

Sponsors & Collaborators

• Pauls Stradins Clinical University Hospital: lead

Study Sites (1)

Pauls Stradins Clinical University Hospital

Riga, LV-1002, Latvia

Location

MeSH Terms

Conditions

Atherosclerosis

Interventions

ALN-PCS

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Karlis Trusinskis, MD

  Pauls Stradins Clinical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 6, 2022
• Study Start: June 29, 2021
• Primary Completion: February 17, 2023
• Study Completion: December 1, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

LA (1)