NCT06586684

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

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: First Affiliated Hospital of Xinjiang Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Carotid Plaque
• Hyperlipidemia
• Echocardiography

Interventions

Type	Name	Description
DRUG	Inclisiran	Patients with carotid plaques undergoing treatment with inclisiran

Timeline

• Start date: 2024-09-20
• Primary completion: 2025-09-30
• Completion: 2026-09-30
• First posted: 2024-09-19
• Last updated: 2024-09-19