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Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support (SPIRIT)

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ClinicalTrials.gov Identifier: NCT04807400
Recruitment Status : Completed
First Posted : March 19, 2021
Last Update Posted : March 20, 2023
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Atherosclerotic Cardiovascular Disease Atherosclerotic Cardiovascular Disease Risk Equivelents Elevated Low Density Lipoprotein Cholesterol Drug: Inclisiran Behavioral: Behavioural Support Phase 3

Detailed Description:

Using implementation science methodology, the study seeks to assess the effect of 9 months treatment with inclisiran with or without behavioural support, compared to standard of care with behavioural support, on LDL-C reduction, total lipid profile, assessments of patient and healthcare professional (HCP) satisfaction, health-care resource utilisation and healthcare service process evaluation.

The primary objective of this study is to demonstrate superiority of inclisiran +/- behavioural support compared to standard of care + behavioural support in a primary care setting, in reducing the percentage change in LDL-C from baseline to Day 270 in adults with elevated LDL-C.

Patients taking part in the study, will do so for 9 months.

Patients taking part in the study will be randomised to one of three groups:

  1. Continue your current lipid lowering medication, plus a telephone-based lifestyle support programme.
  2. Continue your current lipid lowering medication, plus Inclisiran
  3. Continue your current lipid lowering medication, plus Inclisiran and plus a telephone-based lifestyle support programme.

For those patients assigned to group 2 or 3 who will receive Inclisiran, this will be given as an injection from a pre-filled syringe. The patients will be given Inclisiran twice during the study, once at the start of the study on day 1 and a second time 3 months later at day 90.

For those patients assigned to group 1 or 3 they will receive a telephone-based lifestyle support programme. Support will be provided to patients through monthly telephone-based support calls, from a health care professional and health advisors. During the calls, support will be offered to ensure patients understand their cardiovascular disease diagnosis and how to implement lifestyle changes that may reduce their risk.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 899 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open-Label
Primary Purpose: Health Services Research
Official Title: 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.
Actual Study Start Date : July 7, 2021
Actual Primary Completion Date : January 13, 2023
Actual Study Completion Date : January 13, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Background Therapy + Behavioural Support
Participants will continue to receive their background lipid lowering therapy plus behavioural support.
 Behavioral: Behavioural Support
Regular telephone based behavioural support programme delivered throughout the study period.
Experimental: Backgroud Therapy + Inclisiran
Participants will continue to receive their background lipid lowering therapy plus inclisiran for injection.
 Drug: Inclisiran
Inclisiran 300 mg 3 monthly (Day 1 and Day 90)
Experimental: Background Therapy + Inclisiran + Behavioral Support
Participants will continue to receive their background lipid lowering therapy, plus inclisiran for injection, plus behavioural support.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage change in LDL-C from baseline to Day 270 [ Time Frame: 270 days ]
    Superiority of Inclisiran +/- behavioural support compared to standard of care + behavioural support in a primary care setting, in reducing the percentage change in LDL-C from baseline to Day 270 in adults with elevated LDL-C.


Secondary Outcome Measures :
  1. Measurement of patient satisfaction using the validated CSQ-8 (Client Satisfaction Questionnaire) [ Time Frame: Day 90 ]
    Patient satisfaction using CSQ-8 (Client Satisfaction Questionnaire) administered after treatment.

  2. Measures of patient activation and empowerment using the validated Patient Activation Measure (PAM) questionnaire [ Time Frame: Day 90 ]
    Patient activation and empowerment using Patient Activation Measure (PAM) questionnaire administered after treatment

  3. Measures of adherence to cardiovascular disease self-management using the validated Patient Activation Measure (PAM) questionnaire administered after treatment and using assessment of medication adherence during the study period. [ Time Frame: Day 90 ]
    Patient adherence using Patient Activation Measure (PAM) questionnaire administered after treatment

  4. Measurement of Feasibility and acceptability of delivery models for inclisiran to patients [ Time Frame: Day 270 ]
    A process evaluation conducted using the Consolidated Framework for Implementation Research (CFIR) which will explore inclisiran delivery

  5. Measurement of Feasibility and acceptability of delivery models for inclisiran to providers (inner setting) [ Time Frame: Day 270 ]
    A process evaluation conducted using the Consolidated Framework for Implementation Research (CFIR) which will explore inclisiran delivery

  6. Measurement of the wider 'transactability' of the proposed delivery models (outer setting) [ Time Frame: Day 270 ]
    A process evaluation conducted using the Consolidated Framework for Implementation Research (CFIR) which will explore inclisiran delivery

  7. Measurement of the service costs of each delivery model [ Time Frame: Day 270 ]
    A process evaluation conducted using the Consolidated Framework for Implementation Research (CFIR) which will explore inclisiran delivery

  8. Measurement of the acceptability and perceived sustainability of patient identification and referral routes [ Time Frame: Day 270 ]
    A process evaluation conducted using the Consolidated Framework for Implementation Research (CFIR) which will explore inclisiran delivery


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent must be obtained prior to participation in the study.
  2. Patients on established lipid lowering medication or, have been recommended lipid lowering therapy by their health care provider but are unable to tolerate treatment.
  3. A total cholesterol measurement at screening that is ≥4 mmol/L [approximately 160 mg/dL].
  4. 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:

  1. 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 .
  2. Current or planned renal dialysis or transplantation.
  3. Acute coronary syndrome or stroke less than 4 weeks before the screening visit.
  4. Coronary revascularization procedure planned within the next 6 months.
  5. 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.
  6. Women who are pregnant or breast-feeding.
  7. Previous, current or planned treatment with a monoclonal antibody targeting PCSK9, or with a drug known to be contra-indicated with inclisiran.
  8. Previous exposure to inclisiran or participation in a randomised study of inclisiran.
  9. 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.
  10. 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04807400


Locations
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United Kingdom
Novartis Investigative Site
Sale, Cheshire, United Kingdom, M33 4BR
Novartis Investigative Site
Altrincham, Manchester, United Kingdom, WA14 1PF
Novartis Investigative Site
Davyhulme, Manchester, United Kingdom, M41 7WJ
Novartis Investigative Site
Didsbury, Manchester, United Kingdom, M20 6BA
Novartis Investigative Site
Northenden, Manchester, United Kingdom, M22 4DH
Novartis Investigative Site
Sale, Manchester, United Kingdom, M33 2TB
Novartis Investigative Site
Swinton, Manchester, United Kingdom, M27 8HP
Novartis Investigative Site
Wythenshawe, Manchester, United Kingdom, M22 0EP
Novartis Investigative Site
Wythenshawe, Manchester, United Kingdom, M22 5RX
Novartis Investigative Site
Chadderton, United Kingdom, OL9 0LH
Novartis Investigative Site
Cheadle Hulme, United Kingdom, SK8 5LL
Novartis Investigative Site
Greater Manchester, United Kingdom, M24 4DZ
Novartis Investigative Site
Lancashire, United Kingdom, OL6 6EW
Novartis Investigative Site
Manchester, United Kingdom, M14 5NP
Novartis Investigative Site
Manchester, United Kingdom, M14 6WP
Novartis Investigative Site
Manchester, United Kingdom, M20 2RN
Novartis Investigative Site
Manchester, United Kingdom, M33 2RH
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04807400    
Other Study ID Numbers: CKJX839A1GB01
2020-004401-31 ( EudraCT Number )
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: March 20, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Atherosclerotic Cardiovascular Disease
Atherosclerotic Cardiovascular Disease Risk Equivalents
Elevated Low Density Lipoprotein Cholesterol
ASCVD
LDL-C
Additional relevant MeSH terms:
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Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases