At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 3 clinical trial evaluating Inclisiran, Behavioural Support, and 1 other intervention for Atherosclerotic Cardiovascular Disease and 2 related conditions. Completed, enrolled 892 participants across 17 sites.
Detailed 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.
Study Details
Timeline
Interventions
Inclisiran Sodium 300mg on Day 1 and Day 90 by subcutaneous injection
Regular telephone based behavioural support programme delivered throughout the study period, as measured by point of care testing device.
lipid-lowering therapy (such as a statin and/or ezetimibe) as background therapy