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.
Study Type
OBSERVATIONAL
Enrollment
1,868
Prospective observational cohort study. There is no treatment allocation. Patients administered Inclisiran by prescription will be enrolled.
Novartis Investigative Site
Freudenstadt, Baden-Wurttemberg, Germany
Novartis Investigative Site
Heidelberg, Baden-Wurttemberg, Germany
Novartis Investigative Site
Kirchheim unter Teck, Baden-Wurttemberg, Germany
Novartis Investigative Site
Konstanz, Baden-Wurttemberg, Germany
Novartis Investigative Site
Ulm, Baden-Wurttemberg, Germany
Date of first Atherosclerotic Cardiovascular Disease (ASCVD) diagnosis
Date of first Atherosclerotic Cardiovascular Disease (ASCVD) diagnosis is collected
Time frame: Baseline
Number of patients with cardiovascular events
Number of patients with cardiovascular events is collected
Time frame: Baseline
Number of participants with concomitant medication in the previous 12 months
Number of participants with concomitant medication in the previous 12 months is collected
Time frame: Baseline
Number of apheresis treatments in the previous 12 months
Number of apheresis treatments in the previous 12 months is collected
Time frame: Baseline
Lipid lowering therapy used in the previous 12 months
Lipid lowering therapy used in the previous 12 months is collected
Time frame: Baseline
Apheresis plus Inclisiran Cohort: Number of lipid apheresis conducted
Number of lipid apheresis conducted on Apheresis plus Inclisiran cohort is collected
Time frame: Baseline
Low Density Lipoprotein cholesterol (LDL-C)
Low Density Lipoprotein cholesterol (LDL-C) is collected
Time frame: Baseline
Number of In- and outpatient visits
Number of In- and outpatient visits is collected
Time frame: 21 months
Number of examinations
Number of examinations is collected
Time frame: 21 months
Number and types of lipid lowering treatments
Number and types of lipid lowering treatments are collected
Time frame: 21 months
Number of consultations
Number of consultations beside regular visits are collected
Time frame: 21 months
Inclisiran Cohort: Percentage of patients progressing to lipoprotein apheresis after initial Inclisiran therapy over time
Percentage of patients progressing to lipoprotein apheresis after initial Inclisiran therapy over time is collected for the Inclisiran Cohort.
Time frame: 21 months
Percentage of days covered by at least one LLT
Percentage of days covered (PDC) by at least one lipid lowering treatment (LLT) is collected
Time frame: 21 months
Percentage of patients with a PDC ≥ 80% months
Percentage of patients with a Percentage of days covered (PDC) ≥ 80% months is collected
Time frame: 21 months
Time to discontinuation of Inclisiran/ any LLT
Time to discontinuation of Inclisiran/ any lipid lowering treatment (LLT) is collected
Time frame: 21 months
Percentage of patients who discontinue Inclisiran/ any LLT
Percentage of patients who discontinue Inclisiran/ any lipid lowering treatment (LLT) is collected
Time frame: 21 months
Change in LDL-C compared to baseline
Change in Low denisty lipoprotein cholesterine (LDL-C) compared to baseline is measured
Time frame: Baseline, month 3, month 9, month 15, month 21
Changes in TC, HDL-C and non-HDL-C compared to Baseline
Changes in total cholesterol (TC), High Denisty lipoprotein C (HDL-C) and non-HDL-C compared to Baseline is measured
Time frame: Baseline, month 3, month 9, month 15, month 21
Change in c-reactive protein compared to baseline
Change in c-reactive protein compared to baseline is measured
Time frame: Baseline, month 3, month 9, month 15, month 21
Changes in triglycerides and LP(a) compared to baseline
Changes in triglycerides and Lipoprotein (a) (LP(a)) compared to baseline are measured
Time frame: Baseline, month 3, month 9, month 15, month 21
Change in hsCRP compared to Baseline
Change in high-sensitivity C-reactive protein (hs-CRP) compared to Baseline is measured
Time frame: Baseline, month 3, month 9, month 15, month 21
Change in Creatinin compared to baseline
Change in Creatinin compared to baseline is measured
Time frame: Baseline, month 3, month 9, month 15, month 21
Change in HbA1c compared to baseline
Change in Glycated hemoglobin (HbA1c) compared to baseline is measured
Time frame: Baseline, month 3, month 9, month 15, month 21
Change in eGFR compared to baseline
Change in Estimated Glomerular Filtration Rate (eGFR) compared to baseline is measured
Time frame: Baseline, month 3, month 9, month 15, month 21
Proportion of patients achieving prespecified LDL-C targets
Proportion of patients achieving prespecified LDL-C targets based on 2019 ESC/EAS guideline for the management of dyslipidemia is collected
Time frame: Baseline, month 3, month 9, month 15, month 21
Percentage of patients achieving ≥50% LDL-C reduction over time
Percentage of patients achieving ≥50% LDL-C reduction over time is collected
Time frame: Baseline, month 3, month 9, month 15, month 21
Changes in SMART-Risk Scores over time compared to baseline
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.
Time frame: Baseline, month 3, month 9, month 15, month 21
Proportion of patients with treatment modifications
Proportion of patients with the following treatment modifications, is collected: * dose changes * switching of lipid lowering treatment * initiation of lipid apheresis for LDL-C
Time frame: 21 months
Changes from baseline in WHO Quality of Life BREF (WHOQOL-BRED)questionnaire over time
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.
Time frame: Baseline, month 3, month 9, month 15, month 21
Changes from baseline in TSQM-9 over time
Treatment Satisfaction Questionnaire for Medication-9 items (TSQM-9) domain scores range from 0 -100, with higher scores representing higher satisfaction on that domain.
Time frame: Baseline, month 3, month 9, month 15, month 21
Evaluate nutritional factors via questionnaire
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.
Time frame: Baseline, month 3, month 9, month 15, month 21
Percentage of Adverse Events and Serious Adverse Events
Percentage of Adverse Events (AEs) and Serious Adverse Events (SAEs) is collected
Time frame: 21 months
Percentage of Adverse Events and Serious Adverse Events leading to discontinuation of therapy
Percentage of Adverse Events and Serious Adverse Events leading to discontinuation of therapy is collected
Time frame: 21 months
Apheresis plus Inclisiran Cohort: Changes in the rate of lipid apheresis
Changes in the rate of lipid apheresis over time after Inclisiran initiation compared to the period 12 months pre-Baseline is collected.
Time frame: 12 months pre-Baseline, Baseline, month 3, month 9, month 15, month 21
Apheresis plus Inclisiran Cohort: Changes in CRP compared to baseline
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 elevated
Time frame: Baseline, month 3, month 9, month 15, month 21
Apheresis plus Inclisiran Cohort: Changes in PTH
Apheresis plus Inclisiran Cohort: Changes in Parathyroid hormone (PTH)
Time frame: Baseline, month 3, month 9, month 15, month 21
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Novartis Investigative Site
Bayreuth, Bavaria, Germany
Novartis Investigative Site
Coburg, Bavaria, Germany
Novartis Investigative Site
Dachau, Bavaria, Germany
Novartis Investigative Site
Deggendorf, Bavaria, Germany
Novartis Investigative Site
Füssen, Bavaria, Germany
...and 111 more locations