NCT04807400

Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support

A Phase IIIb, Multicentre, Randomised Controlled Study to Evaluate the Implementation, Preference and Utility for Administration of Inclisiran Sodium in Participants With Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD-risk Equivalents and Elevated Low Density Lipoprotein Cholesterol (LDL-C) Using a Primary Care Models in the NHS.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 892 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

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

Timeline

• Start date: 2021-07-07
• Primary completion: 2023-01-13
• Completion: 2023-01-13
• First posted: 2021-03-19
• Last updated: 2024-10-09
• Results posted: 2024-03-25

Locations

17 sites across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study