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Carotid PlaquePhase 4NCT06586684

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

A Phase 4 study testing Inclisiran in people with Carotid Plaque and Hyperlipidemia, run by First Affiliated Hospital of Xinjiang Medical University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Carotid Plaque, Hyperlipidemia, Echocardiography
What is being tested?
Inclisiran
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
20 Sep 2024to 30 Sep 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • - 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);
Show all 11Show fewer
  • 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.

Trial locations and contacts

No sites are listed yet.

Yuanhao Yao, MD contact

09914366872 ext. +86

yyh991012@outlook.com

About this study

Official title: 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.

Read the 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.

Being tested
Inclisiran
Keywords
inclisiran, carotid plaque, Echocardiography, hyperlipidmia
Medical subject headings
Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InclisiranDrug

    Patients with carotid plaques undergoing treatment with inclisiran

Study groups in NCT06586684
Study groupRoleWhat they receive
inclisiran Therapy groupExperimentalPatients with carotid plaques undergoing treatment with inclisiran
Receives: Drug: Inclisiran

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CIMT

    Carotid artery intima media thickness

    Measured: Immediately and treated with inclisiran one year later

  2. TMPT

    The maximal plaque thickness

    Measured: Immediately and treated with inclisiran one year later

  3. CPA

    Carotid plaque area

    Measured: Immediately and treated with inclisiran one year later

  4. CPV

    Carotid plaque volume

    Measured: Immediately and treated with inclisiran one year later

  5. CALA

    Carotid artery lumen area

    Measured: Immediately and treated with inclisiran one year later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start20 Sep 2024 (estimated)
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06586684
Sponsor's protocol ID
EICP-UCG
Status last verified
Sep 2024
First submitted
1 Sep 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will be made available on reasonable request to the official agencies.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 36967822

  • Ray KK, Kallend D, Leiter LA, Raal FJ, Koenig W, Jaros MJ, Schwartz GG, Landmesser U, Garcia Conde L, Wright RS; ORION-11 Investigators. Effect of inclisiran on lipids in primary prevention: the ORION-11 trial. Eur Heart J. 2022 Dec 21;43(48):5047-5057. doi: 10.1093/eurheartj/ehac615.

    PubMed 36331315

  • Chen J, Zhao F, Lei C, Qi T, Xue X, Meng Y, Zhang W, Zhang H, Wang J, Zhu H, Cheng C, Wang Q, Bi C, Song B, Jin C, Niu Q, An F, Li B, Huo X, Zhao Y, Li B. Effect of evolocumab on the progression of intraplaque neovascularization of the carotid based on contrast-enhanced ultrasonography (EPIC study): A prospective single-arm, open-label study. Front Pharmacol. 2023 Jan 4;13:999224. doi: 10.3389/fphar.2022.999224. eCollection 2022.

    PubMed 36686711

  • Aranzulla TC, Piazza S, Ricotti A, Musumeci G, Gaggiano A. CARotid plaqUe StabilizatiOn and regression with evolocumab: Rationale and design of the CARUSO study. Catheter Cardiovasc Interv. 2021 Jul 1;98(1):E115-E121. doi: 10.1002/ccd.29743. Epub 2021 Apr 24.

    PubMed 33893754

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Inclisiran in people with Carotid Plaque and Hyperlipidemia, run by First Affiliated Hospital of Xinjiang Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yuanhao Yao, MD (09914366872 ext. +86, yyh991012@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CIMT (time frame: Immediately and treated with inclisiran one year later). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06586684, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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