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Be Part of Research - Trial Details - A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.

A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.

Medical Conditions

Cardiovascular Diseases
Atherosclerosis


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Mar 2023 Apr 2029

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Subcutaneous injection in pre-filled syringe.

Intervention Arm Group : Inclisiran sodium 300mg;

Intervention Type : DRUG
Intervention Description : Matching placebo in 1.5ml solution for injection

Intervention Arm Group : Placebo;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Novartis Investigative Site
    Norwich
    NR4 7UY
  • Novartis Investigative Site
    High Wycombe
    Buckinghamshire
    HP11 2TT
  • Novartis Investigative Site
    Dorchester
    Dorset
    DT1 2JY
  • Novartis Investigative Site
    Harrow
    Middlesex
    HA1 3UJ
  • Novartis Investigative Site
    Portadown
    Nothern Ireland
    BT63 5QQ
  • Novartis Investigative Site
    Wansford
    Peterborough
    PE8 6PL
  • Novartis Investigative Site
    Sheffield
    S5 7AU
  • Novartis Investigative Site
    Wiltshire
    SN15 2SB
  • Novartis Investigative Site
    Wrexham
    LL13 7TD
  • Novartis Investigative Site
    Kettering
    NN16 8UZ
  • Novartis Investigative Site
    London
    GBR
    EC1M 6BQ
  • Novartis Investigative Site
    Tyne And Wear
    NE29 8NH
  • Novartis Investigative Site
    London
    W12 0HS
  • Novartis Investigative Site
    Cardiff
    Wales
    CF5 4AD
  • Novartis Investigative Site
    Cardiff
    CF64 2XX
  • Novartis Investigative Site
    Chesterfield
    S40 4AA
  • Novartis Investigative Site
    Edinburgh
    ED16 4SA
  • Novartis Investigative Site
    Glasgow
    G20 7BE
  • Novartis Investigative Site
    Londonderry
    BT47 1SB
  • Novartis Investigative Site
    Rhyl
    LL18 5UJ
  • Novartis Investigative Site
    Luton
    Beds
    LU4 0DZ
  • Novartis Investigative Site
    Blackpool
    FY3 8NR
  • Novartis Investigative Site
    Salford
    M6 8HD
  • Novartis Investigative Site
    Peterborough
    Cambridgeshire
    PE3 9GZ
  • Novartis Investigative Site
    Bristol
    BS2 8HW
  • Novartis Investigative Site
    Plymouth
    PL5 3JB
  • Novartis Investigative Site
    Exeter
    Devon
    EX2 5DW
  • Novartis Investigative Site
    Scunthorpe
    DN15 7GB
  • Novartis Investigative Site
    Fowey
    Cornwall
    PL23 1DT
  • Novartis Investigative Site
    Liskeard
    Cornwall
    PL14 3XA
  • Novartis Investigative Site
    Lancashire
    FY4 3AD
  • Novartis Investigative Site
    Belfast
    BT7 2BE
  • Novartis Investigative Site
    Birmingham
    B21 9RY
  • Novartis Investigative Site
    Wirrel
    CH62 6EE
  • Novartis Investigative Site
    Middlesex
    TW7 6AF
  • Novartis Investigative Site
    Bristol
    South Gloucestershire
    BS37 4AX
  • Novartis Investigative Site
    Denbighshire
    LL181DA
  • Novartis Investigative Site
    Belfast
    BT16 1RH
  • Novartis Investigative Site
    Newquay
    Cornwall
    TR7 1RU
  • Novartis Investigative Site
    Plympton
    PL7 2QP
  • Novartis Investigative Site
    Corby
    Northamptonshire
    NN17 2UR
  • Novartis Investigative Site
    Connor Downs
    Cornwall
    TR27 5DT
  • Novartis Investigative Site
    Bury St Edmunds
    Suffolk
    IP33 2QZ
  • Novartis Investigative Site
    Hardwick
    Stockton On Tees
    TS19 8PE
  • Novartis Investigative Site
    Cardiff
    Wales
    CF23 9PN


The study is sponsored by Novartis Pharmaceuticals




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Read full details for Trial ID: NCT05739383
Last updated 19 March 2025

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