Phase 3
N=892
Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support
Atherosclerotic Cardiovascular Disease · Atherosclerotic Cardiovascular Disease Risk Equivelents · Elevated Low Density Lipoprotein Cholesterol
Bottom Line
View on ClinicalTrials.gov: NCT04807400 ↗Enrolled (actual)
892
Serious AEs
10.4%
Results posted
Mar 2024
Primary outcome: Primary: Percentage Change in LDL-C From Baseline to Day 270 — -37.3; -37.6; -5.4 percent change from baseline in LDL-C — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Inclisiran (Drug); Behavioural Support (Behavioral); Background lipid lowering therapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in LDL-C From Baseline to Day 270 |
-37.3; -37.6; -5.4 | <0.001 sig |
| SECONDARY Number of Participants Interviewed for CFIR Analysis. |
28; 28 | — |
| SECONDARY Patient Reported Outcomes: CSQ-8 Total Score After Treatment |
30.1; 30.1; 28.7 | <0.001 sig |
| SECONDARY Patient Reported Outcomes: CSQ-8 Total Score Between Inclisiran Arms |
30.1; 30.1 | 0.9347 |
| SECONDARY Change From Baseline to Day 90 in Total PAM Score |
2.4; 2.7; 1.4 | 0.6759 |
| SECONDARY Change From Baseline to Day 90 in Total PAM Score Between Inclisiran Arms |
2.6; 2.3 | 0.8580 |
| SECONDARY Measures of Adherence to Cardiovascular Disease Self-management Using the Validated Patient Activation Measure (PAM) Questionnaire. |
13; 20; 7; 47; 50; 15 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
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 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
Data sourced from ClinicalTrials.gov (NCT04807400). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.