Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support
SPIRIT
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.
2 other identifiers
interventional
892
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2021
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2021
CompletedFirst Posted
Study publicly available on registry
March 19, 2021
CompletedStudy Start
First participant enrolled
July 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 13, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2023
CompletedResults Posted
Study results publicly available
March 25, 2024
CompletedOctober 9, 2024
October 1, 2024
1.5 years
March 17, 2021
January 11, 2024
October 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage Change in LDL-C From Baseline to Day 270
Change in Low Density Lipoprotein Cholesterol (LDL-C) after 270 days of treatment in adults on established lipid lowering medication or who have been recommended lipid lowering therapy by their health care provider but are unable to tolerate treatment, regardless of treatment discontinuation for any reason and regardless of unforeseen change in the concomitant lipid lowering therapy. Multiple imputation is used to impute missing data using a washout model.
Baseline, Day 270
Secondary Outcomes (6)
Number of Participants Interviewed for CFIR Analysis.
Day 270
Patient Reported Outcomes: CSQ-8 Total Score After Treatment
Day 90
Patient Reported Outcomes: CSQ-8 Total Score Between Inclisiran Arms
Day 90
Change From Baseline to Day 90 in Total PAM Score
Baseline, Day 90
Change From Baseline to Day 90 in Total PAM Score Between Inclisiran Arms
Baseline, Day 90
- +1 more secondary outcomes
Study Arms (3)
Control+ BS
ACTIVE COMPARATORParticipants continued to receive their background lipid lowering therapy plus behavioural support (BS).
Inclisiran
EXPERIMENTALParticipants continue to receive their background lipid lowering therapy, plus inclisiran for injection (delivered in an injection-only model).
Inclisiran + BS
EXPERIMENTALParticipants continued to receive their background lipid lowering therapy, plus inclisiran for injection, plus behavioural support.
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
Eligibility Criteria
You may qualify if:
- Signed informed consent had to 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 were unable to tolerate treatment.
- A total cholesterol measurement at screening that was ≥4 mmol/L \[approximately 160 mg/dL\].
- Participants on lipid-lowering therapies had to be on a stable dose for ≥30 days before screening with no planned medication or dose change.
You may not qualify if:
- 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 planed to move away from the geographical area where the study is being conducted during the study period.
- A triglyceride measurement at screening that is greater than or equal to 4.52 mmol/L
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Novartis Investigative Site
Sale, Cheshire, M33 4BR, United Kingdom
Novartis Investigative Site
Altrincham, Manchester, WA14 1PF, United Kingdom
Novartis Investigative Site
Davyhulme, Manchester, M41 7WJ, United Kingdom
Novartis Investigative Site
Didsbury, Manchester, M20 6BA, United Kingdom
Novartis Investigative Site
Northenden, Manchester, M22 4DH, United Kingdom
Novartis Investigative Site
Sale, Manchester, M33 2TB, United Kingdom
Novartis Investigative Site
Swinton, Manchester, M27 8HP, United Kingdom
Novartis Investigative Site
Wythenshawe, Manchester, M22 0EP, United Kingdom
Novartis Investigative Site
Wythenshawe, Manchester, M22 5RX, United Kingdom
Novartis Investigative Site
Chadderton, OL9 0LH, United Kingdom
Novartis Investigative Site
Cheadle Hulme, SK8 5LL, United Kingdom
Novartis Investigative Site
Greater Manchester, M24 4DZ, United Kingdom
Novartis Investigative Site
Lancashire, OL6 6EW, United Kingdom
Novartis Investigative Site
Manchester, M14 5NP, United Kingdom
Novartis Investigative Site
Manchester, M14 6WP, United Kingdom
Novartis Investigative Site
Manchester, M20 2RN, United Kingdom
Novartis Investigative Site
Manchester, M33 2RH, United Kingdom
Related Publications (2)
Wilson P, Elvey R, Mathieson A, Bower P, Gibson M, Vell T, Dixon S. Evaluating the implementation of inclisiran in primary care: process evaluation interim findings from interviews with key stakeholders. BMJ Open. 2025 Feb 26;15(2):e083441. doi: 10.1136/bmjopen-2023-083441.
PMID: 40010816DERIVEDMathieson A, Elvey R, Wilson P. Development and application of a qualitative rapid analysis framework in a hybrid trial within primary care. BMJ Open. 2024 Jul 24;14(7):e076792. doi: 10.1136/bmjopen-2023-076792.
PMID: 39053958DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Open-Label
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2021
First Posted
March 19, 2021
Study Start
July 7, 2021
Primary Completion
January 13, 2023
Study Completion
January 13, 2023
Last Updated
October 9, 2024
Results First Posted
March 25, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com