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Not yet recruiting NCT06586684

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

Phase IV Interventional Carotid Plaque Hyperlipidemia Echocardiography

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Inclisiran.
Who it may be relevant to
Registry conditions: Carotid Plaque, Hyperlipidemia, Echocardiography. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Inclisiran
    Patients with carotid plaques undergoing treatment with inclisiran

Primary outcome measures

  • CIMT [Time frame: Immediately and treated with inclisiran one year later]
  • TMPT [Time frame: Immediately and treated with inclisiran one year later]
  • CPA [Time frame: Immediately and treated with inclisiran one year later]
  • CPV [Time frame: Immediately and treated with inclisiran one year later]
  • CALA [Time frame: Immediately and treated with inclisiran one year later]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Ray KK, Wright RS, Kallend D, Koenig W, Leiter LA, Raal FJ, Bisch JA, Richardson T, Jaros M, Wijngaard PLJ, Kastelein JJP; ORION-10 and ORION-11 Investigators. Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol. N Engl J Med. 2020 Apr 16;382(16):1507-1519. doi: 10.1056/NEJMoa1912387. Epub 2020 Mar 18. PMID 32187462
  • Wright RS, Ray KK, Raal FJ, Kallend DG, Jaros M, Koenig W, Leiter LA, Landmesser U, Schwartz GG, Friedman A, Wijngaard PLJ, Garcia Conde L, Kastelein JJP; ORION Phase III Investigators. Pooled Patient-Level Analysis of Inclisiran Trials in Patients With Familial Hypercholesterolemia or Atherosclerosis. J Am Coll Cardiol. 2021 Mar 9;77(9):1182-1193. doi: 10.1016/j.jacc.2020.12.058. PMID 33663735
  • Huo Y, Lesogor A, Lee CW, Chiang CE, Mena-Madrazo J, Poh KK, Jeong MH, Maheux P, Zhang M, Wei S, Han Y, Li Y. Efficacy and Safety of Inclisiran in Asian Patients: Results From ORION-18. JACC Asia. 2023 Nov 14;4(2):123-134. doi: 10.1016/j.jacasi.2023.09.006. eCollection 2024 Feb. PMID 38371290
  • Mantella LE, Colledanchise KN, Hetu MF, Feinstein SB, Abunassar J, Johri AM. Carotid intraplaque neovascularization predicts coronary artery disease and cardiovascular events. Eur Heart J Cardiovasc Imaging. 2019 Nov 1;20(11):1239-1247. doi: 10.1093/ehjci/jez070. PMID 31621834
  • Wong EY, Nikolov HN, Rankin RN, Holdsworth DW, Poepping TL. Evaluation of distal turbulence intensity for the detection of both plaque ulceration and stenosis grade in the carotid bifurcation using clinical Doppler ultrasound. Eur Radiol. 2013 Jun;23(6):1720-8. doi: 10.1007/s00330-012-2741-6. Epub 2012 Dec 18. PMID 23247808
  • Wright RS, Collins MG, Stoekenbroek RM, Robson R, Wijngaard PLJ, Landmesser U, Leiter LA, Kastelein JJP, Ray KK, Kallend D. Effects of Renal Impairment on the Pharmacokinetics, Efficacy, and Safety of Inclisiran: An Analysis of the ORION-7 and ORION-1 Studies. Mayo Clin Proc. 2020 Jan;95(1):77-89. doi: 10.1016/j.mayocp.2019.08.021. Epub 2019 Oct 17. PMID 31630870
  • Crouse JR 3rd, Raichlen JS, Riley WA, Evans GW, Palmer MK, O'Leary DH, Grobbee DE, Bots ML; METEOR Study Group. Effect of rosuvastatin on progression of carotid intima-media thickness in low-risk individuals with subclinical atherosclerosis: the METEOR Trial. JAMA. 2007 Mar 28;297(12):1344-53. doi: 10.1001/jama.297.12.1344. Epub 2007 Mar 25. PMID 17384434
  • Wu L, Kong Q, Huang H, Xu S, Qu W, Zhang P, Yu Z, Luo X. Effect of PCSK9 inhibition in combination with statin therapy on intracranial atherosclerotic stenosis: A high-resolution MRI study. Front Aging Neurosci. 2023 Mar 9;15:1127534. doi: 10.3389/fnagi.2023.1127534. eCollection 2023. PMID 36967822

Identifiers

NCT: NCT06586684 · EICP-UCG

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗