Atherosclerotic Cardiovascular Disease
Conditions
Keywords
NIS, atherosclerotic cardiovascular disease, ASCVD, BE.REAL, BE REAL, inclisiran, Belgium
Brief summary
This is an observational non-interventional study. The visit schedule is according to the routine clinical practice. Only data corresponding to study variables within the specified study period will be collected. The study will recruit patients into one single cohort: Inclisiran in combination with other LLTs. The patients will receive Inclisiran therapy as per the approved label and Belgian reimbursement conditions.
Detailed description
The study aims to assess the effectiveness, safety and adherence for Inclisiran in combination with lipid-lowering therapy (LLT) under conditions of routine clinical practice. The Inclisiran cohort will include patients receiving Inclisiran therapy as per the approved label independently of background Standard of Care (SoC) therapy. This study will include both primary data collection and secondary use of data.
Interventions
OTHERInclisiran
There is no treatment allocation. Patients administered inclisiran by prescription will be enrolled. The patients will receive inclisiran therapy as per the approved label and Belgian reimbursement conditions.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who are 18 years or older. 2. Patients with Atherosclerotic Cardiovascular Disease (ASCVD) who are eligible for commercially available Leqvio, as defined by the reimbursement criteria: Patients with ASCVD documented by previous coronary heart disease (CHD), cerebrovascular disease or peripheral artery disease (PAD) and LDL-C ≥ 100mg/dL despite a treatment of min 6 weeks with max tolerated statin (unless intolerance or contra-indication) in combination with ezetimibe (unless intolerance or contra-indication). 3. Heterozygous Familial Hypercholesterolemia (HeFH) patients with documented ASCVD who are eligible for commercially available Leqvio. 4. Patients who provide written informed consent to participate in the study.
Exclusion criteria
1. Patients who have received Inclisiran previously. 2. Patients participating in a clinical trial with investigational product. 3. Heterozygous Familial Hypercholesterolemia patients without established Atherosclerotic Cardiovascular Disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean percent change in LDL-C from baseline | Baseline, up to 39 months | Mean percent change in Low-Density Lipoprotein Cholesterol (LDL-C) from baseline will be collected |
| Mean absolute change in LDL-C from baseline | Baseline, up to 39 months | Mean absolute change in Low-Density Lipoprotein Cholesterol (LDL-C) from baseline |
| Percentage of patients achieving the guideline-recommended LDL-C target at any time | Up to 39 months | Percentage of patients achieving the guideline-recommended Low-Density Lipoprotein Cholesterol (LDL-C) target at any time will be collected |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients maintaining the guideline-recommended LDL-C target | Up to 39 months | Percentage of patients maintaining the guideline-recommended LDL-C target (once achieved) for the duration of the study will be collected |
| Time- adjusted percentage change in LDL-C from baseline | Baseline, month 3, month 9, month 15, month 21, month 27, month 33, month 39 | time- adjusted percentage change in LDL-C from baseline to 3 months (2nd injection), 9 months (3rd injection), 15 months (4th injection), 21 months (5th injection), 27 months (6th injection), 33 months (7th injection) and 39 months (8th injection) |
| Change in LDL-C from baseline stratified on background therapy | Baseline, up to 39 months | Change in LDL-C from baseline stratified on background therapy will be collected |
| Percentage of patients remaining on Inclisiran therapy at each injection visit | Up to 39 months | Percentage of patients remaining on Inclisiran therapy at each injection visit will be collected |
| Percentage of patients with dose changes, switching, discontinuation | Up to 39 months | Percentage of patients with dose changes, switching or discontinuation will be collected |
| Number of ASCVD-related events | Up to 39 months | Number of atherosclerotic cardiovascular disease (ASCVD)-related events will be collected |
| Number of possibly related adverse events | Up to 39 months | Number of possibly related adverse events will be collected |
| Number of injection site reactions | Up to 39 months | Number of injection site reactions will be collected |
| Number of patients with changes in Lp(a) levels for Inclisiran-treated patients | Up to 39 months | Number of patients with changes in Lipoprotein (a) levels for Inclisiran-treated patients will be collected |
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed