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The Effect of Small Interfering RNA Inclisiran on Carotid Plaques in Patients with Atherosclerosis: a Real-world Study Using Carotid Ultrasound.
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.
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Start Date
September 20, 2024
Primary Completion Date
September 30, 2025
Completion Date
September 30, 2026
Last Updated
September 19, 2024
40
ESTIMATED participants
Inclisiran
DRUG
Lead Sponsor
First Affiliated Hospital of Xinjiang Medical University
NCT06062394
NCT07230730
Data Source & Attribution
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