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NCT Number: NCT06586684

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inclisiran

Drug

Patients with carotid plaques undergoing treatment with inclisiran

Primary outcomes

  1. CIMT

    Time frame: Immediately and treated with inclisiran one year later

    Carotid artery intima media thickness

  2. TMPT

    Time frame: Immediately and treated with inclisiran one year later

    The maximal plaque thickness

  3. CPA

    Time frame: Immediately and treated with inclisiran one year later

    Carotid plaque area

  4. CPV

    Time frame: Immediately and treated with inclisiran one year later

    Carotid plaque volume

  5. CALA

    Time frame: Immediately and treated with inclisiran one year later

    Carotid artery lumen area

Study contacts

Contact information is provided by the study sponsor or research team.

Yuanhao Yao, MD

CONTACT

[email protected]

09914366872 ext. +86

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Xinjiang Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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