Atherosclerotic Cardiovascular DiseasePhase 3SPIRITNCT04807400
Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support
A Phase 3 study testing Inclisiran, Behavioural Support and Background lipid lowering therapy in people with Atherosclerotic Cardiovascular Disease and Atherosclerotic Cardiovascular Disease Risk Equivelents, run by Novartis Pharmaceuticals at 17 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease, Atherosclerotic Cardiovascular Disease Risk Equivelents, Elevated Low Density Lipoprotein Cholesterol
- What is being tested?
- Inclisiran, Behavioural Support and Background lipid lowering therapy
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 892 participants
- Where
- 17 sitesUnited Kingdom
- Study dates
- 7 Jul 2021to 13 Jan 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United Kingdom17 sites
Novartis Investigative Site
Altrincham, Manchester, WA14 1PF
Novartis Investigative Site
Chadderton, OL9 0LH
Novartis Investigative Site
Cheadle Hulme, SK8 5LL
Novartis Investigative Site
Davyhulme, Manchester, M41 7WJ
Novartis Investigative Site
Didsbury, Manchester, M20 6BA
Novartis Investigative Site
Greater Manchester, M24 4DZ
Novartis Investigative Site
Lancashire, OL6 6EW
Novartis Investigative Site
Manchester, M14 5NP
Novartis Investigative Site
Manchester, M14 6WP
Novartis Investigative Site
Manchester, M20 2RN
Novartis Investigative Site
Manchester, M33 2RH
Novartis Investigative Site
Northenden, Manchester, M22 4DH
Novartis Investigative Site
Sale, Cheshire, M33 4BR
Novartis Investigative Site
Sale, Manchester, M33 2TB
Novartis Investigative Site
Swinton, Manchester, M27 8HP
Novartis Investigative Site
Wythenshawe, Manchester, M22 0EP
Novartis Investigative Site
Wythenshawe, Manchester, M22 5RX
About this study
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.
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.
Read the detailed description
A phase IIIb, multicenter, randomized controlled study to evaluate the implementation, preference, and utility for administration of inclisiran sodium in participants on established lipid lowering medication or, have been recommended lipid lowering therapy by their healthcare provider but are unable to tolerate treatment, with elevated low density lipoprotein cholesterol (LDL-C) in a primary care population. This study was an implementation research study that utilized implementation science methodology and use of the electronic medical record (EMR).
Using implementation science methodology, the study intended to assess the effect of 9 months treatment with inclisiran with/without behavioural support, compared to standard of care + behavioural support, on LDL-C reduction, total lipid profile, assessments of patient and healthcare professional (HCP) satisfaction, health-care resource utilization and healthcare service process evaluation.
The primary focus of this study was implementation and 'transactability' - how to organize, deliver and maintain an innovative treatment for Atherosclerotic Cardiovascular Disease (ASCVD) in a primary care setting in a sustainable way.
Patients taking part in the study were randomised to one of three groups:
- Control + BS: Participants continued to receive their background lipid lowering therapy plus behavioural support. Subjects in treatment group 1 were referred to as the control group in this study
- Inclisiran: Participants continue to receive their background lipid lowering therapy, plus inclisiran for injection (delivered in an injection-only model).
- Inclisiran + BS: Participants continued to receive their background lipid lowering therapy, plus inclisiran for injection, plus behavioural support.
Participants who were randomized to Inclisiran or Inclisiran + BS received one injection of inclisiran on Day 1 and a second injection of inclisiran on Day 90.
Participants in Control + BS and Inclisiran + BS received a monthly telephone call from a health advisor, providing support to enable participants to make positive behaviour changes to reduce their cardiovascular risk.
- Conditions
- Atherosclerotic Cardiovascular Disease, Atherosclerotic Cardiovascular Disease Risk Equivelents, Elevated Low Density Lipoprotein Cholesterol
- Being tested
- Inclisiran, Behavioural Support, Background lipid lowering therapy
- Keywords
- Atherosclerotic Cardiovascular Disease, Atherosclerotic Cardiovascular Disease Risk Equivalents, Elevated Low Density Lipoprotein Cholesterol, ASCVD, LDL-C
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InclisiranDrug
Inclisiran Sodium 300mg on Day 1 and Day 90 by subcutaneous injection
Behavioural SupportBehavioural
Regular telephone based behavioural support programme delivered throughout the study period, as measured by point of care testing device.
Background lipid lowering therapyDrug
lipid-lowering therapy (such as a statin and/or ezetimibe) as background therapy
| Study group | Role | What they receive |
|---|---|---|
| Control+ BS | Active comparator | Participants continued to receive their background lipid lowering therapy plus behavioural support (BS). Receives: Behavioral: Behavioural Support; Drug: Background lipid lowering therapy |
| Inclisiran | Experimental | Participants continue to receive their background lipid lowering therapy, plus inclisiran for injection (delivered in an injection-only model). Receives: Drug: Inclisiran; Drug: Background lipid lowering therapy |
| Inclisiran + BS | Experimental | Participants continued to receive their background lipid lowering therapy, plus inclisiran for injection, plus behavioural support. Receives: Drug: Inclisiran; Behavioral: Behavioural Support; Drug: Background lipid lowering therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Day 270
Secondary outcomes (6)
Number of Participants Interviewed for CFIR Analysis.
To identify the need to support the implementation of inclisiran in the real world, a framework was drawn known as the Consolidated Framework for Implementation Research (CFIR). Patients who received inclisiran were interviewed to understand their experience with the program and to obtain a comprehensive understanding, with or without behavioural support. These patients were interviewed on various aspects of their experience related to their high cholesterol management, trial participation, inclisiran injections, attending appointments, and if applicable their experience with the behavioural support programme.
These interviews were not set up in a way that allow numerical analysis. The process evaluation was conducted by Manchester University.
Measured: Day 270
Patient Reported Outcomes: CSQ-8 Total Score After Treatment
The Client Satisfaction Questionnaire (CSQ)-8 is the standard self-administered CSQ scale containing 8 items that comprise the measurement of satisfaction with services and measurement of improvement of capacity to cope and change adaptively. Items include questions enquiring about respondents' opinions and conclusions about services they have received or are currently receiving. Response options differ from item to item, but all are based on a four-point scale. For the CSQ-8 version, scores range from 8 to 32, with higher values indicating higher satisfaction.
Measured: Day 90
Patient Reported Outcomes: CSQ-8 Total Score Between Inclisiran Arms
The CSQ-8 is the standard self-administered CSQ scale containing 8 items that comprise the measurement of satisfaction with services and measurement of improvement of capacity to cope and change adaptively. Items include questions enquiring about respondents' opinions and conclusions about services they have received or are currently receiving. Response options differ from item to item, but all are based on a four-point scale. For the CSQ-8 version, scores range from 8 to 32, with higher values indicating higher satisfaction.
This secondary outcome only analysed data of the two Inclisiran arms, by considering the Inclisiran only arm as the control group. The standard error for Least Square Mean could change because dropping a treatment arm affects the estimation of treatment effects and the variability of data.
Measured: Day 90
Change From Baseline to Day 90 in Total PAM Score
The Patient Activation Measure (PAM) questionnaire is a survey that assesses a person's underlying knowledge, skills and confidence integral to managing his or her own health and healthcare.
This study used the 13-point PAM questionnaire, which consists of 13 statements relating to patients beliefs about health care, confidence in their management of health related tasks, and self-assessed knowledge of their condition. For each statement patients are required to say how much they either agree or disagree on a response scale of 1-5, where 1 represents "strongly disagree", 4 represents "strongly agree" and 5 indicates that the statement is "not applicable" to them. A standardised spreadsheet in excel is used to score the PAM. Responses are used to generate a continuous score from 0 to 100 where higher scores indicate that the patient is more activated.
Measured: Baseline, Day 90
Change From Baseline to Day 90 in Total PAM Score Between Inclisiran Arms
The Patient Activation Measure (PAM) questionnaire is a survey that assesses a person's underlying knowledge, skills and confidence integral to managing his or her own health and healthcare. This study used the 13-point PAM questionnaire, which consists of 13 statements. For each statement patients are required to say how much they either agree or disagree on a response scale of 1-5, where 1 represents "strongly disagree", 4 represents "strongly agree" and 5 indicates that the statement is "not applicable" to them. Responses are used to generate a continuous score from 0 to 100 where higher scores indicate that the patient is more activated.
This outcome only analysed data of the two inclisiran arms, by considering the Inclisiran only arm as the control group. In an ANCOVA model, the Least Squares Means and corresponding Standard Error could change because the removal of a treatment group affects the estimation of the treatment effects and the adjustment for the covariate(s).
Measured: Baseline, Day 90
Measures of Adherence to Cardiovascular Disease Self-management Using the Validated Patient Activation Measure (PAM) Questionnaire.
The Patient Activation Measure (PAM) questionnaire is a survey that assesses a person's underlying knowledge, skills and confidence integral to managing his or her own health and healthcare.
This study used the 13-point PAM questionnaire, which consists of 13 statements relating to patients beliefs about health care, confidence in their management of health related tasks, and self-assessed knowledge of their condition. For each statement patients are required to say how much they either agree or disagree on a response scale of 1-5, where 1 represents "strongly disagree", 4 represents "strongly agree" and 5 indicates that the statement is "not applicable" to them. Responses are used to generate a continuous score from 0 to 100.
The continuous PAM scores are then categorised into 4 levels: Level 1 - disengaged and overwhelmed; Level 2 - become aware but still struggling; Level 3 - taking action; Level 4 - maintaining behaviors and pushing further.
Measured: Baseline, Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start7 Jul 2021
- Primary completion13 Jan 2023
- Study completion13 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atherosclerotic Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 892 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807400
- Sponsor's protocol ID
- CKJX839A1GB01
- Other IDs
- 2020-004401-31
- Acronym
- SPIRIT
- Status last verified
- Oct 2024
- First submitted
- 17 Mar 2021
- Last updated
- 9 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 40010816Mathieson 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.
PubMed 39053958
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04807400
- Acronym / sponsor ID
- SPIRIT / CKJX839A1GB01
- Conditions
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 892 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 19 Mar 2021 (actual)
- Results
- Posted 25 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A phase IIIb, multicenter, randomized controlled study to evaluate the implementation, preference, and utility for administration of inclisiran sodium in participants on established lipid lowering medication or, have been recommended lipid lowering therapy by their healthcare provider but are unable to tolerate treatment, with elevated low density lipoprotein cholesterol (LDL-C) in a primary care population. This study was an implementation research study that utilized implementation science methodology and use of the electronic medical record (EMR).
Using implementation science methodology, the study intended to assess the effect of 9 months treatment with inclisiran with/without behavioural support, compared to standard of care + behavioural support, on LDL-C reduction, total lipid profile, assessments of patient and healthcare professional (HCP) satisfaction, health-care resource utilization and healthcare service process evaluation.
The primary focus of this study was implementation and 'transactability' - how to organize, deliver and maintain an innovative treatment for Atherosclerotic Cardiovascular Disease (ASCVD) in a primary care setting in a sustainable way.
Patients taking part in the study were randomised to one of three groups:
- Control + BS: Participants continued to receive their background lipid lowering therapy plus behavioural support. Subjects in treatment group 1 were referred to as the control group in this study
- Inclisiran: Participants continue to receive their background lipid lowering therapy, plus inclisiran for injection (delivered in an injection-only model).
- Inclisiran + BS: Participants continued to receive their background lipid lowering therapy, plus inclisiran for injection, plus behavioural support.
Participants who were randomized to Inclisiran or Inclisiran + BS received one injection of inclisiran on Day 1 and a second injection of inclisiran on Day 90.
Participants in Control + BS and Inclisiran + BS received a monthly telephone call from a health advisor, providing support to enable participants to make positive behaviour changes to reduce their cardiovascular risk.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control+ BS | Active comparator | Behavioral: Behavioural Support, Drug: Background lipid lowering therapyParticipants continued to receive their background lipid lowering therapy plus behavioural support (BS). |
| Inclisiran | Experimental | Drug: Inclisiran, Drug: Background lipid lowering therapyParticipants continue to receive their background lipid lowering therapy, plus inclisiran for injection (delivered in an injection-only model). |
| Inclisiran + BS | Experimental | Drug: Inclisiran, Behavioral: Behavioural Support, Drug: Background lipid lowering therapyParticipants continued to receive their background lipid lowering therapy, plus inclisiran for injection, plus behavioural support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InclisiranInclisiran Sodium 300mg on Day 1 and Day 90 by subcutaneous injection | Drug | Inclisiran, Inclisiran + BS |
| Behavioural SupportRegular telephone based behavioural support programme delivered throughout the study period, as measured by point of care testing device. | Behavioural | Control+ BS, Inclisiran + BS |
| Background lipid lowering therapylipid-lowering therapy (such as a statin and/or ezetimibe) as background therapy | Drug | Control+ BS, Inclisiran, Inclisiran + BS |
Primary outcome
Percentage Change in LDL-C From Baseline to Day 270
Time frame: Baseline, 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.
6 secondary outcomes
Number of Participants Interviewed for CFIR Analysis.
Time frame: Day 270
Patient Reported Outcomes: CSQ-8 Total Score After Treatment
Time frame: Day 90
Patient Reported Outcomes: CSQ-8 Total Score Between Inclisiran Arms
Time frame: Day 90
Change From Baseline to Day 90 in Total PAM Score
Time frame: Baseline, Day 90
Change From Baseline to Day 90 in Total PAM Score Between Inclisiran Arms
Time frame: Baseline, Day 90
Measures of Adherence to Cardiovascular Disease Self-management Using the Validated Patient Activation Measure (PAM) Questionnaire.
Time frame: Baseline, Day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40010816Wilson 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.
- Derived from this study: PubMed 39053958Mathieson 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.
- A Plain Language Trial Summary is available on novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inclisiran, Behavioural Support and Background lipid lowering therapy in people with Atherosclerotic Cardiovascular Disease and Atherosclerotic Cardiovascular Disease Risk Equivelents, run by Novartis Pharmaceuticals at 17 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in LDL-C From Baseline to Day 270 (time frame: Baseline, Day 270). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04807400, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.