A Non-interventional Implementation Study to Evaluate Treatment With Inclisiran (Leqvio®) and Other Lipid Lowering Treatments in a Real-world Setting
- Conditions
- Hypercholesterolemia
- Interventions
- Other: Inclisiran
- Registration Number
- NCT05362903
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This is a multicenter, non-randomized, non-interventional three-cohort study with prospective collection of primary data of treatment with newly initiated oral Lipid lowering treatment on top of a statin (Oral LLT cohort), newly initiated Inclisiran (Inclisiran cohort) and newly initiated Inclisiran on top of lipid apheresis (Apheresis plus Inclisiran cohort) in routine clinical care. All procedures, treatment adaptions and laboratory assessments are part of clinicla routine and conducted independent of this study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2030
- Patients who provide written informed consent to participate in the study
- Male or female patients ≥ 18 years of age
- Oral LLT Cohort: Patients with documented ASCVD newly initiated on an oral lipid lowering treatment on top of a statin (e.g. ezetimibe, bempedoic acid, cholestyraimin)
- Inclisiran Cohort: Patients newly initiated on Inclisiran fulfilling the restricted reimbursement criteria or individual access requirements who are not at LDL-C goal as per their CV risk as recommended in the 2019 EAS/ESC guidelines (Mach et al., 2020). At least 60% of the documented patients must be PCSK9-inhibitor naive
- Apheresis plus Inclisiran Cohort: Patients with Inclisiran on top of regular weekly or bi-weekly lipoprotein apheresis (LDL-c or LP(a)).
- Oral LLT Cohort: Patients who receive a PCSK9-mAB or other PCSK9-targeted therapy
- Inclisiran 1 Cohort: current or previous PCSK9-targeted treatment
- Contraindication for Inclisiran according to the SmPC
- Patients who have received Inclisiran previously
- Patients with homozygous FH
- Any underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate) might interfere with interpretation of the clinical study results.
- Simultaneous or planned participation in an interventional research study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Inclisiran Inclisiran Patients who newly initiated Inclisiran 1. Inclisiran in a PCSK9-treatment naive cohort 2. Inclisiran in patients with prior PCSK9-antibody treatment Apheresis plus Inclisiran Inclisiran Patients who newly initiated Inclisiran on top of lipid apheresis
- Primary Outcome Measures
Name Time Method Apheresis plus Inclisiran Cohort: Number of lipid apheresis conducted Baseline Number of lipid apheresis conducted on Apheresis plus Inclisiran cohort is collected
Date of first Atherosclerotic Cardiovascular Disease (ASCVD) diagnosis Baseline Date of first Atherosclerotic Cardiovascular Disease (ASCVD) diagnosis is collected
Number of patients with cardiovascular events Baseline Number of patients with cardiovascular events is collected
Number of apheresis treatments in the previous 12 months Baseline Number of apheresis treatments in the previous 12 months is collected
Number of participants with concomitant medication in the previous 12 months Baseline Number of participants with concomitant medication in the previous 12 months is collected
Lipid lowering therapy used in the previous 12 months Baseline Lipid lowering therapy used in the previous 12 months is collected
Low Density Lipoprotein cholesterol (LDL-C) Baseline Low Density Lipoprotein cholesterol (LDL-C) is collected
- Secondary Outcome Measures
Name Time Method Number of examinations 21 months Number of examinations is collected
Number and types of lipid lowering treatments 21 months Number and types of lipid lowering treatments are collected
Percentage of days covered by at least one LLT 21 months Percentage of days covered (PDC) by at least one lipid lowering treatment (LLT) is collected
Percentage of patients who discontinue Inclisiran/ any LLT 21 months Percentage of patients who discontinue Inclisiran/ any lipid lowering treatment (LLT) is collected
Changes in SMART-Risk Scores over time compared to baseline Baseline, month 3, month 9, month 15, month 21 The SMART Risk Score is a tool to estimate 10-year risk for recurrent vascular events in patients with manifest cardiovascular disease. SMART Risk Score ranges from 0 - 100 %, where higher values indicate higher cv risk.
Number of consultations 21 months Number of consultations beside regular visits are collected
Inclisiran Cohort: Percentage of patients progressing to lipoprotein apheresis after initial Inclisiran therapy over time 21 months Percentage of patients progressing to lipoprotein apheresis after initial Inclisiran therapy over time is collected for the Inclisiran Cohort.
Changes in triglycerides and LP(a) compared to baseline Baseline, month 3, month 9, month 15, month 21 Changes in triglycerides and Lipoprotein (a) (LP(a)) compared to baseline are measured
Change in HbA1c compared to baseline Baseline, month 3, month 9, month 15, month 21 Change in Glycated hemoglobin (HbA1c) compared to baseline is measured
Apheresis plus Inclisiran Cohort: Changes in the rate of lipid apheresis 12 months pre-Baseline, Baseline, month 3, month 9, month 15, month 21 Changes in the rate of lipid apheresis over time after Inclisiran initiation compared to the period 12 months pre-Baseline is collected.
Number of In- and outpatient visits 21 months Number of In- and outpatient visits is collected
Percentage of patients with a PDC ≥ 80% months 21 months Percentage of patients with a Percentage of days covered (PDC) ≥ 80% months is collected
Changes in TC, HDL-C and non-HDL-C compared to Baseline Baseline, month 3, month 9, month 15, month 21 Changes in total cholesterol (TC), High Denisty lipoprotein C (HDL-C) and non-HDL-C compared to Baseline is measured
Change in Creatinin compared to baseline Baseline, month 3, month 9, month 15, month 21 Change in Creatinin compared to baseline is measured
Percentage of patients achieving ≥50% LDL-C reduction over time Baseline, month 3, month 9, month 15, month 21 Percentage of patients achieving ≥50% LDL-C reduction over time is collected
Evaluate nutritional factors via questionnaire Baseline, month 3, month 9, month 15, month 21 Questionnaire from the German "Nationale Verzehrstudie II -Was esse ich" is used. No score is used for the interpretation. Questions about nutrition and activities are interpreted separately and compared over time.
Percentage of Adverse Events and Serious Adverse Events leading to discontinuation of therapy 21 months Percentage of Adverse Events and Serious Adverse Events leading to discontinuation of therapy is collected
Apheresis plus Inclisiran Cohort: Changes in CRP compared to baseline Baseline, month 3, month 9, month 15, month 21 Changes in high-sensitive C-reactive protein (hsCRP) are measured in labs. Values are interpresetd as;
- less or 1.0 mg/l is normal 1.01 - 3.00 slightly high more than 3.0 mg/l is significantly elevatedChange in LDL-C compared to baseline Baseline, month 3, month 9, month 15, month 21 Change in Low denisty lipoprotein cholesterine (LDL-C) compared to baseline is measured
Change in c-reactive protein compared to baseline Baseline, month 3, month 9, month 15, month 21 Change in c-reactive protein compared to baseline is measured
Proportion of patients achieving prespecified LDL-C targets Baseline, month 3, month 9, month 15, month 21 Proportion of patients achieving prespecified LDL-C targets based on 2019 ESC/EAS guideline for the management of dyslipidemia is collected
Proportion of patients with treatment modifications 21 months Proportion of patients with the following treatment modifications, is collected:
* dose changes
* switching of lipid lowering treatment
* initiation of lipid apheresis for LDL-CChanges from baseline in WHO Quality of Life BREF (WHOQOL-BRED)questionnaire over time Baseline, month 3, month 9, month 15, month 21 Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale. Higher numbers indicate better QoL.
Changes from baseline in TSQM-9 over time Baseline, month 3, month 9, month 15, month 21 Treatment Satisfaction Questionnaire for Medication-9 items (TSQM-9) domain scores range from 0 -100, with higher scores representing higher satisfaction on that domain.
Apheresis plus Inclisiran Cohort: Changes in PTH Baseline, month 3, month 9, month 15, month 21 Apheresis plus Inclisiran Cohort: Changes in Parathyroid hormone (PTH)
Time to discontinuation of Inclisiran/ any LLT 21 months Time to discontinuation of Inclisiran/ any lipid lowering treatment (LLT) is collected
Change in hsCRP compared to Baseline Baseline, month 3, month 9, month 15, month 21 Change in high-sensitivity C-reactive protein (hs-CRP) compared to Baseline is measured
Change in eGFR compared to baseline Baseline, month 3, month 9, month 15, month 21 Change in Estimated Glomerular Filtration Rate (eGFR) compared to baseline is measured
Percentage of Adverse Events and Serious Adverse Events 21 months Percentage of Adverse Events (AEs) and Serious Adverse Events (SAEs) is collected
Trial Locations
- Locations (1)
Novartis Investigative Site
🇩🇪Zwiesel, Germany