Effect of Small Interfering RNA Inclisiran on Carotid Plaques As Assessed by Carotid Ultrasound

Launched by FIRST AFFILIATED HOSPITAL OF XINJIANG MEDICAL UNIVERSITY · Sep 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called inclisiran to see how it affects carotid plaques, which are fatty deposits in the arteries that can increase the risk of heart problems. The goal is to understand if inclisiran can make these plaques more stable and less likely to cause serious cardiovascular events. This study will involve patients aged 18 to 75 years who have specific cholesterol levels and ultrasound-confirmed carotid plaques.

To be eligible, participants should not have any serious allergies to certain cholesterol medications, and they shouldn't have a history of major heart surgeries or strokes. This trial is currently not recruiting participants, but once it starts, those who join can expect to undergo ultrasound imaging to monitor the condition of their carotid plaques. This research aims to provide important information that could help doctors better manage patients with high cholesterol and carotid artery issues in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with carotid plaques as indicated by ultrasound
• • Men and women aged 18-75 years;
• • LDL-C \>3.4 mmol/L without regular statin therapy or LDL-C \>1.8 mmol/L after 4 weeks of statin lipid-lowering therapy.
• Exclusion Criteria:
• • - Known allergies or contraindications to PCSK9 inhibitors and/or statin therapy;
• • Prior use of PCSK9 inhibitors;
• • Prior history of hemorrhagic stroke;
• • Prior coronary artery bypass grafting or coronary intervention;
• • Inability to perform OCT imaging or unclear imaging;
• • Severe renal insufficiency (creatinine clearance \< 30 mL/min);
• • Severe hepatic dysfunction;
• • Baseline triglycerides \> 5.6 mmol/L;
• • Pregnant or lactating women;
• • Life expectancy not exceeding 1 year;
• • In the judgment of the investigator, unsuitable for this study for any reason.