Trial · NCT04807400
Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support
NCT04807400, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2024-03-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support. Trials, record NCT04807400. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04807400
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support
- NCT number
- NCT04807400
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 892 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Atherosclerotic Cardiovascular Disease, Atherosclerotic Cardiovascular Disease Risk Equivelents, Elevated Low Density Lipoprotein Cholesterol
- Interventions
- Inclisiran, Behavioural Support, Background lipid lowering therapy
- First posted
- 2021-03-19
- Last updated
- 2024-10-09
- Other registries' IDs
- eudract:2020-004401-31
- Results first posted
- 2024-03-25
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change in LDL-C From Baseline to Day 270 | 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. |
| Secondary | Number of Participants Interviewed for CFIR Analysis. | Day 270 | 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. |
| Secondary | Patient Reported Outcomes: CSQ-8 Total Score After Treatment | Day 90 | 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. |
| Secondary | Patient Reported Outcomes: CSQ-8 Total Score Between Inclisiran Arms | Day 90 | 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. |
| Secondary | Change From Baseline to Day 90 in Total PAM Score | Baseline, Day 90 | 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. |
| Secondary | Change From Baseline to Day 90 in Total PAM Score Between Inclisiran Arms | Baseline, Day 90 | 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). |
| Secondary | Measures of Adherence to Cardiovascular Disease Self-management Using the Validated Patient Activation Measure (PAM) Questionnaire. | Baseline, Day 90 | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Change in LDL-C From Baseline to Day 270 | Baseline, Day 270 | Full analysis set. The Full Analysis Set (FAS) comprised of all randomized participants except for those mis-randomized participants who did not receive study drug. Only participants with LDL-C values at both, baseline and Day 270, were included in the analysis. | percent change from baseline in LDL-C | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Interviewed for CFIR Analysis. | Day 270 | All patients randomized to inclisiran | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Patient Reported Outcomes: CSQ-8 Total Score After Treatment | Day 90 | Full analysis set: The Full Analysis Set (FAS) comprised of all randomized participants except for those mis-randomized participants who did not receive study drug. Only participants with CSQ-8 assessment Day 90, were included in the analysis. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Patient Reported Outcomes: CSQ-8 Total Score Between Inclisiran Arms | Day 90 | Full analysis set: The Full Analysis Set (FAS) comprised of all randomized participants except for those mis-randomized participants who did not receive study drug. Only participants assigned to inclisiran with CSQ-8 assessment Day 90, were included in the analysis. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Day 90 in Total PAM Score | Baseline, Day 90 | Full analysis set: The Full Analysis Set (FAS) comprised of all randomized participants except for those mis-randomized participants who did not receive study drug. Only participants with PAM assessment at both, Baseline and Day 90, were included in the analysis. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Day 90 in Total PAM Score Between Inclisiran Arms | Baseline, Day 90 | Full analysis set: The Full Analysis Set (FAS) comprised of all randomized participants except for those mis-randomized participants who did not receive study drug. Only participants assigned to inlcisiran with PAM assessment at Day 90, were included in the analysis. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Measures of Adherence to Cardiovascular Disease Self-management Using the Validated Patient Activation Measure (PAM) Questionnaire. | Baseline, Day 90 | Full analysis set: The Full Analysis Set (FAS) comprised of all randomized participants except for those mis-randomized participants who did not receive study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Change in LDL-C From Baseline to Day 270 | Inclisiran | -37.3 | Standard Error 2.29 | percent change from baseline in LDL-C | |
| Percentage Change in LDL-C From Baseline to Day 270 | Inclisiran + BS | -37.6 | Standard Error 2.33 | percent change from baseline in LDL-C | |
| Percentage Change in LDL-C From Baseline to Day 270 | Control+ BS | -5.4 | Standard Error 2.34 | percent change from baseline in LDL-C | |
| Number of Participants Interviewed for CFIR Analysis. | Inclisiran | 28 | Participants | ||
| Number of Participants Interviewed for CFIR Analysis. | Inclisiran + BS | 28 | Participants | ||
| Patient Reported Outcomes: CSQ-8 Total Score After Treatment | Inclisiran | 30.1 | Standard Error 0.24 | score on a scale | |
| Patient Reported Outcomes: CSQ-8 Total Score After Treatment | Inclisiran + BS | 30.1 | Standard Error 0.24 | score on a scale | |
| Patient Reported Outcomes: CSQ-8 Total Score After Treatment | Control+ BS | 28.7 | Standard Error 0.30 | score on a scale | |
| Patient Reported Outcomes: CSQ-8 Total Score Between Inclisiran Arms | Inclisiran + BS | 30.1 | Standard Error 0.23 | score on a scale | |
| Patient Reported Outcomes: CSQ-8 Total Score Between Inclisiran Arms | Inclisiran | 30.1 | Standard Error 0.23 | score on a scale |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Inclisiran | 298 | |
| Overall Study | STARTED | Inclisiran + BS | 297 | |
| Overall Study | STARTED | Control+ BS | 297 | |
| Overall Study | Full Analysis Set | Inclisiran | 297 | |
| Overall Study | Full Analysis Set | Inclisiran + BS | 297 | |
| Overall Study | Full Analysis Set | Control+ BS | 297 | |
| Overall Study | Safety Set | Inclisiran | 273 | |
| Overall Study | Safety Set | Inclisiran + BS | 281 | |
| Overall Study | Safety Set | Control+ BS | 290 | |
| Overall Study | COMPLETED | Inclisiran | 248 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events448
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site rash | General disorders | Inclisiran | 1 | 273 | |
| other | Injection site rash | General disorders | Inclisiran + BS | 0 | 281 | |
| other | Injection site rash | General disorders | Control + BS | 0 | 290 | |
| other | Injection site rash | General disorders | Total | 1 | 844 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Inclisiran | 1 | 273 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Inclisiran + BS | 0 | 281 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Control + BS | 0 | 290 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Total | 1 | 844 | |
| other | Muscle spasms | Musculoskeletal and connective tissue disorders | Inclisiran | 1 | 273 | |
| other | Muscle spasms | Musculoskeletal and connective tissue disorders | Inclisiran + BS | 0 | 281 |
1 to 10 of 448Source ClinicalTrials.gov
See all 448 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Inclisiran | 2 | 273 |
| Total, all-cause mortality | Inclisiran + BS | 0 | 281 |
| Total, all-cause mortality | Control + BS | 0 | 290 |
| Total, all-cause mortality | Total | 2 | 844 |
| Total, other adverse events | Inclisiran | 3 | 273 |
| Total, other adverse events | Inclisiran + BS | 2 | 281 |
| Total, other adverse events | Control + BS | 0 | 290 |
| Total, other adverse events | Total | 5 | 844 |
| Total, serious adverse events | Inclisiran | 24 | 273 |
| Total, serious adverse events | Inclisiran + BS | 36 | 281 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Inclisiran vs Inclisiran + BS: Number of Participants Interviewed for CFIR Analysis. |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04807400
GET https://conductscience.org/api/trials/v1/NCT04807400/results?page=2