Back to resultsStudy in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support (SPIRIT)
Primary Purpose
Atherosclerotic Cardiovascular Disease, Atherosclerotic Cardiovascular Disease Risk Equivelents, Elevated Low Density Lipoprotein Cholesterol
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Inclisiran
Behavioural Support
Sponsored by
About this trial
This is an interventional health services research trial for Atherosclerotic Cardiovascular Disease focused on measuring Atherosclerotic Cardiovascular Disease, Atherosclerotic Cardiovascular Disease Risk Equivalents, Elevated Low Density Lipoprotein Cholesterol, ASCVD, LDL-C
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.
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Background Therapy + Behavioural Support
Backgroud Therapy + Inclisiran
Background Therapy + Inclisiran + Behavioral Support
Arm Description
Participants will continue to receive their background lipid lowering therapy plus behavioural support.
Participants will continue to receive their background lipid lowering therapy plus inclisiran for injection.
Participants will continue to receive their background lipid lowering therapy, plus inclisiran for injection, plus behavioural support.
Outcomes
Primary Outcome Measures
Percentage change in LDL-C from baseline to Day 270
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
Measurement of patient satisfaction using the validated CSQ-8 (Client Satisfaction Questionnaire)
Patient satisfaction using CSQ-8 (Client Satisfaction Questionnaire) administered after treatment.
Measures of patient activation and empowerment using the validated Patient Activation Measure (PAM) questionnaire
Patient activation and empowerment using Patient Activation Measure (PAM) questionnaire administered after treatment
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.
Patient adherence using Patient Activation Measure (PAM) questionnaire administered after treatment
Measurement of Feasibility and acceptability of delivery models for inclisiran to patients
A process evaluation conducted using the Consolidated Framework for Implementation Research (CFIR) which will explore inclisiran delivery
Measurement of Feasibility and acceptability of delivery models for inclisiran to providers (inner setting)
A process evaluation conducted using the Consolidated Framework for Implementation Research (CFIR) which will explore inclisiran delivery
Measurement of the wider 'transactability' of the proposed delivery models (outer setting)
A process evaluation conducted using the Consolidated Framework for Implementation Research (CFIR) which will explore inclisiran delivery
Measurement of the service costs of each delivery model
A process evaluation conducted using the Consolidated Framework for Implementation Research (CFIR) which will explore inclisiran delivery
Measurement of the acceptability and perceived sustainability of patient identification and referral routes
A process evaluation conducted using the Consolidated Framework for Implementation Research (CFIR) which will explore inclisiran delivery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04807400
Brief Title
Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support
Acronym
SPIRIT
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 7, 2021 (Actual)
Primary Completion Date
January 13, 2023 (Actual)
Study Completion Date
January 13, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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:
Continue your current lipid lowering medication, plus a telephone-based lifestyle support programme.
Continue your current lipid lowering medication, plus Inclisiran
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerotic Cardiovascular Disease, Atherosclerotic Cardiovascular Disease Risk Equivelents, Elevated Low Density Lipoprotein Cholesterol
Keywords
Atherosclerotic Cardiovascular Disease, Atherosclerotic Cardiovascular Disease Risk Equivalents, Elevated Low Density Lipoprotein Cholesterol, ASCVD, LDL-C
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Open-Label
Allocation
Randomized
Enrollment
899 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Background Therapy + Behavioural Support
Arm Type
Experimental
Arm Description
Participants will continue to receive their background lipid lowering therapy plus behavioural support.
Arm Title
Backgroud Therapy + Inclisiran
Arm Type
Experimental
Arm Description
Participants will continue to receive their background lipid lowering therapy plus inclisiran for injection.
Arm Title
Background Therapy + Inclisiran + Behavioral Support
Arm Type
Experimental
Arm Description
Participants will continue to receive their background lipid lowering therapy, plus inclisiran for injection, plus behavioural support.
Intervention Type
Drug
Intervention Name(s)
Inclisiran
Intervention Description
Inclisiran 300 mg 3 monthly (Day 1 and Day 90)
Intervention Type
Behavioral
Intervention Name(s)
Behavioural Support
Intervention Description
Regular telephone based behavioural support programme delivered throughout the study period.
Primary Outcome Measure Information:
Title
Percentage change in LDL-C from baseline to Day 270
Description
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.
Time Frame
270 days
Secondary Outcome Measure Information:
Title
Measurement of patient satisfaction using the validated CSQ-8 (Client Satisfaction Questionnaire)
Description
Patient satisfaction using CSQ-8 (Client Satisfaction Questionnaire) administered after treatment.
Time Frame
Day 90
Title
Measures of patient activation and empowerment using the validated Patient Activation Measure (PAM) questionnaire
Description
Patient activation and empowerment using Patient Activation Measure (PAM) questionnaire administered after treatment
Time Frame
Day 90
Title
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.
Description
Patient adherence using Patient Activation Measure (PAM) questionnaire administered after treatment
Time Frame
Day 90
Title
Measurement of Feasibility and acceptability of delivery models for inclisiran to patients
Description
A process evaluation conducted using the Consolidated Framework for Implementation Research (CFIR) which will explore inclisiran delivery
Time Frame
Day 270
Title
Measurement of Feasibility and acceptability of delivery models for inclisiran to providers (inner setting)
Description
A process evaluation conducted using the Consolidated Framework for Implementation Research (CFIR) which will explore inclisiran delivery
Time Frame
Day 270
Title
Measurement of the wider 'transactability' of the proposed delivery models (outer setting)
Description
A process evaluation conducted using the Consolidated Framework for Implementation Research (CFIR) which will explore inclisiran delivery
Time Frame
Day 270
Title
Measurement of the service costs of each delivery model
Description
A process evaluation conducted using the Consolidated Framework for Implementation Research (CFIR) which will explore inclisiran delivery
Time Frame
Day 270
Title
Measurement of the acceptability and perceived sustainability of patient identification and referral routes
Description
A process evaluation conducted using the Consolidated Framework for Implementation Research (CFIR) which will explore inclisiran delivery
Time Frame
Day 270
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Sale
State/Province
Cheshire
ZIP/Postal Code
M33 4BR
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Altrincham
State/Province
Manchester
ZIP/Postal Code
WA14 1PF
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Davyhulme
State/Province
Manchester
ZIP/Postal Code
M41 7WJ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Didsbury
State/Province
Manchester
ZIP/Postal Code
M20 6BA
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Northenden
State/Province
Manchester
ZIP/Postal Code
M22 4DH
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Sale
State/Province
Manchester
ZIP/Postal Code
M33 2TB
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Swinton
State/Province
Manchester
ZIP/Postal Code
M27 8HP
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Wythenshawe
State/Province
Manchester
ZIP/Postal Code
M22 0EP
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Wythenshawe
State/Province
Manchester
ZIP/Postal Code
M22 5RX
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Chadderton
ZIP/Postal Code
OL9 0LH
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Cheadle Hulme
ZIP/Postal Code
SK8 5LL
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Greater Manchester
ZIP/Postal Code
M24 4DZ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Lancashire
ZIP/Postal Code
OL6 6EW
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Manchester
ZIP/Postal Code
M14 5NP
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Manchester
ZIP/Postal Code
M14 6WP
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Manchester
ZIP/Postal Code
M20 2RN
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Manchester
ZIP/Postal Code
M33 2RH
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support
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