The Effect of Small Interfering RNA Inclisiran on Carotid Plaques in Patients with Atherosclerosis: a Real-world Study Using Carotid Ultrasound.

First Affiliated Hospital of Xinjiang Medical University0 个研究点目标入组 40 人开始时间: 2024年9月20日最近更新: 2024年9月6日

适应症

干预措施

试验速览

阶段: 4 期
状态: 尚未招募
发起方
入组人数: 40
主要终点: CIMT

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

Current understanding suggests that the majority of cardiovascular events are driven by vulnerable plaques. Nonetheless, the impact of PCSK9 inhibitors on the stability of carotid plaques remains insufficiently elucidated, with a notable scarcity of relevant clinical studies. This investigation seeks to address this gap through a real-world study conducted among patients with arterial sclerosis in Asia. The primary aim is to evaluate the effects of small interfering RNA (inclisiran) on carotid plaque characteristics as assessed by ultrasound, thereby contributing valuable data to inform clinical practice.

详细描述

In a meticulous study evaluating the impact of inclisiran on patients with atherosclerosis and carotid plaques, data were systematically gathered across multiple time points. The assessment encompassed:Blood Samples: Analyzed at baseline (Month 0) and subsequently at Months 1, 2, 3, 5, 9, 11, and 12, examining biochemical markers, lipid profiles, and liver and kidney function tests.Carotid Ultrasound: Conducted at Months 0, 3, 9, and 12, monitoring the carotid intima-media thickness, maximum carotid plaque thickness, carotid plaque area, carotid plaque volume, and carotid lumen stenosis area for thorough analysis.Clinical Records: Documented in detail the baseline clinical information, biochemical markers, imaging findings, and any adverse cardiovascular or cerebrovascular events that occurred throughout the study period. This approach ensures a comprehensive understanding of inclisiran's effects over time, encompassing both biochemical and imaging parameters, while tracking potential adverse events.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•- 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.

研究组 & 干预措施

inclisiran Therapy group

Experimental

Patients with carotid plaques undergoing treatment with inclisiran

干预措施: Inclisiran (Drug)