Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support

Last updated: October 7, 2024
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Hypercholesterolemia

Atherosclerosis

Vascular Diseases

Treatment

Background lipid lowering therapy

Behavioural Support

Inclisiran

Clinical Study ID

NCT04807400
CKJX839A1GB01
2020-004401-31
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study was to evaluate the implementation of inclisiran in a regional primary care setting in the UK

Inclisiran, also known as KJX839, is a medication made to reduce the level of "bad" cholesterol (LDL-cholesterol) in the blood. Inclisiran works in a way that makes the liver produce less of a substance called 'PCSK9'. PCSK9 reduces the ability of the liver to remove LDL-cholesterol from the blood. By lowering the production of PCSK9, Inclisiran leads to more LDL-cholesterol being removed by the liver from the blood, thereby reducing LDL-cholesterol overall.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Signed informed consent had to be obtained prior to participation in the study.

  2. Patients on established lipid lowering medication or, have been recommended lipidlowering therapy by their health care provider but were unable to toleratetreatment.

  3. A total cholesterol measurement at screening that was ≥4 mmol/L [approximately 160mg/dL].

  4. Participants on lipid-lowering therapies had to be on a stable dose for ≥30 daysbefore screening with no planned medication or dose change.

Exclusion

Exclusion Criteria:

  1. Medical or surgical history that might limit the individual's ability to take studytreatments for the duration of the study and/or put the participant at significantrisk .

  2. Current or planned renal dialysis or transplantation.

  3. Acute coronary syndrome or stroke less than 4 weeks before the screening visit.

  4. Coronary revascularization procedure planned within the next 6 months.

  5. Women of child-bearing potential, unless they agree to abstinence or, if sexuallyactive, agree to the use of effective methods of contraception during the study.

  6. Women who are pregnant or breast-feeding.

  7. Previous, current or planned treatment with a monoclonal antibody targeting PCSK9,or with a drug known to be contra-indicated with inclisiran.

  8. Previous exposure to inclisiran or participation in a randomised study ofinclisiran.

  9. Current or previous participation in a clinical study with an unlicensed drug ordevice within 30 days or five half-lives of the screening visit, whichever islonger.

  10. Participants who planed to move away from the geographical area where the study isbeing conducted during the study period.

  11. A triglyceride measurement at screening that is greater than or equal to 4.52 mmol/L

Study Design

Total Participants: 892
Treatment Group(s): 3
Primary Treatment: Background lipid lowering therapy
Phase: 3
Study Start date:
July 07, 2021
Estimated Completion Date:
January 13, 2023

Study Description

A phase IIIb, multicenter, randomized controlled study to evaluate the implementation, preference, and utility for administration of inclisiran sodium in participants on established lipid lowering medication or, have been recommended lipid lowering therapy by their healthcare provider but are unable to tolerate treatment, with elevated low density lipoprotein cholesterol (LDL-C) in a primary care population. This study was an implementation research study that utilized implementation science methodology and use of the electronic medical record (EMR).

Using implementation science methodology, the study intended to assess the effect of 9 months treatment with inclisiran with/without behavioural support, compared to standard of care + behavioural support, on LDL-C reduction, total lipid profile, assessments of patient and healthcare professional (HCP) satisfaction, health-care resource utilization and healthcare service process evaluation.

The primary focus of this study was implementation and 'transactability' - how to organize, deliver and maintain an innovative treatment for Atherosclerotic Cardiovascular Disease (ASCVD) in a primary care setting in a sustainable way.

Patients taking part in the study were randomised to one of three groups:

  • Control + BS: Participants continued to receive their background lipid lowering therapy plus behavioural support. Subjects in treatment group 1 were referred to as the control group in this study

  • Inclisiran: Participants continue to receive their background lipid lowering therapy, plus inclisiran for injection (delivered in an injection-only model).

  • Inclisiran + BS: Participants continued to receive their background lipid lowering therapy, plus inclisiran for injection, plus behavioural support.

Participants who were randomized to Inclisiran or Inclisiran + BS received one injection of inclisiran on Day 1 and a second injection of inclisiran on Day 90.

Participants in Control + BS and Inclisiran + BS received a monthly telephone call from a health advisor, providing support to enable participants to make positive behaviour changes to reduce their cardiovascular risk.

Connect with a study center

  • Novartis Investigative Site

    Altrincham, Manchester WA14 1PF
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Davyhulme, Manchester M41 7WJ
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Didsbury, Manchester M20 6BA
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Northenden, Manchester M22 4DH
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Sale, Manchester M33 2TB
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Swinton, Manchester M27 8HP
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Wythenshawe, Manchester M22 5RX
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Chadderton, OL9 0LH
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Cheadle Hulme, SK8 5LL
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Greater Manchester, M24 4DZ
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Lancashire, OL6 6EW
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Manchester, M14 6WP
    United Kingdom

    Site Not Available

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