Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04807400
Phase
PHASE3
Status
Completed

Conditions

  • Atherosclerotic Cardiovascular Disease
  • Atherosclerotic Cardiovascular Disease Risk Equivelents
  • Elevated Low Density Lipoprotein Cholesterol

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Inclisiran — DRUG
    Inclisiran Sodium 300mg on Day 1 and Day 90 by subcutaneous injection
  • Behavioural Support — BEHAVIORAL
    Regular telephone based behavioural support programme delivered throughout the study period, as measured by point of care testing device.
  • Background lipid lowering therapy — DRUG
    lipid-lowering therapy (such as a statin and/or ezetimibe) as background therapy

Study Details

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.

Key Dates

Start date
Jul 7, 2021
Status verified
Oct 2024
Primary completion
Jan 13, 2023
Completion
Jan 13, 2023

Study Design

Enrollment
892 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Control+ BS
    Participants continued to receive their background lipid lowering therapy plus behavioural support (BS).
  • Experimental: Inclisiran
    Participants continue to receive their background lipid lowering therapy, plus inclisiran for injection (delivered in an injection-only model).
  • Experimental: Inclisiran + BS
    Participants continued to receive their background lipid lowering therapy, plus inclisiran for injection, plus behavioural support.

Primary Outcome Measure

Percentage Change in LDL-C From Baseline to Day 270 [ Time Frame: Baseline, Day 270 ]

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