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.

ClinicalTrials.gov Identifier: NCT04807400

Novartis Reference Number: CKJX839A1GB01

Last Update: Dec 03, 2021

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of the study is to find out if a study treatment called Inclisiran can be given in regional primary care setting (i.e. at a GP surgery in the NHS) in the UK, and to understand how this health care service may be set-up by the NHS.

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.

About 900 patients will participate in this study, at about 20 GP surgeries across the Greater Manchester area within the UK.

Condition 
Atherosclerotic Cardiovascular Disease
Atherosclerotic Cardiovascular Disease Risk Equivelents
Elevated Low Density Lipoprotein Cholesterol
Phase 
Phase 3
Overall status 
Recruiting
Start date 
Jul 07, 2021
Completion date 
Sep 16, 2022
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Inclisiran
Inclisiran 300 mg 3 monthly (Day 1 and Day 90)
Behavioral
Behavioural Support
Regular telephone based behavioural support programme delivered throughout the study period.

Eligibility Criteria

Inclusion Criteria:

Signed informed consent must be obtained prior to participation in the study.
Patients on established lipid lowering medication or, have been recommended lipid lowering therapy by their health care provider but are unable to tolerate treatment.
A total cholesterol measurement at screening that is ≥4 mmol/L [approximately 160 mg/dL].
Participants on lipid-lowering therapies should be on a stable dose for ≥30 days before screening with no planned medication or dose change.

Exclusion Criteria:

Medical or surgical history that might limit the individual's ability to take study treatments for the duration of the study and/or put the participant at significant risk .
Current or planned renal dialysis or transplantation.
Acute coronary syndrome or stroke less than 4 weeks before the screening visit.
Coronary revascularization procedure planned within the next 6 months.
Women of child-bearing potential, unless they agree to abstinence or, if sexually active, agree to the use of effective methods of contraception during the study.
Women who are pregnant or breast-feeding.
Previous, current or planned treatment with a monoclonal antibody targeting PCSK9, or with a drug known to be contra-indicated with inclisiran.
Previous exposure to inclisiran or participation in a randomised study of inclisiran.
Current or previous participation in a clinical study with an unlicensed drug or device within 30 days or five half-lives of the screening visit, whichever is longer.
Participants who plan to move away from the geographical area where the study is being conducted during the study period.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Locations

United Kingdom
Novartis Investigative Site
Recruiting
Sale, M33 4BR
Cheshire
United Kingdom
Novartis Investigative Site
Recruiting
Altrincham, WA14 1PF
Manchester
United Kingdom
Novartis Investigative Site
Recruiting
Davyhulme, M41 7WJ
Manchester
United Kingdom
Novartis Investigative Site
Recruiting
Didsbury, M20 6BA
Manchester
United Kingdom
Novartis Investigative Site
Recruiting
Northenden, M22 4DH
Manchester
United Kingdom
Novartis Investigative Site
Recruiting
Sale, M33 2TB
Manchester
United Kingdom
Novartis Investigative Site
Recruiting
Swinton, M27 8HP
Manchester
United Kingdom
Novartis Investigative Site
Recruiting
Wythenshawe, M22 0EP
Manchester
United Kingdom
Novartis Investigative Site
Recruiting
Wythenshawe, M22 5RX
Manchester
United Kingdom
Novartis Investigative Site
Recruiting
Cheadle Hulme, SK8 5LL
-
United Kingdom
Novartis Investigative Site
Recruiting
Lancashire, OL6 6EW
-
United Kingdom
Novartis Investigative Site
Recruiting
Manchester, M14 6WP
-
United Kingdom
Novartis Investigative Site
Recruiting
Manchester, M20 2RN
-
United Kingdom
Novartis Investigative Site
Recruiting
Manchester, M33 2RH
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]