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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inclisiran | Patients prescribed inclisiran on top of standard of care lipid-lowering therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inclisiran | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean percent change in LDL-C from baseline | Mean percent change in Low-Density Lipoprotein Cholesterol (LDL-C) from baseline will be collected | Baseline, up to 39 months |
| Mean absolute change in LDL-C from baseline | Mean absolute change in Low-Density Lipoprotein Cholesterol (LDL-C) from baseline | Baseline, up to 39 months |
| Percentage of patients achieving the guideline-recommended LDL-C target at any time | Percentage of patients achieving the guideline-recommended Low-Density Lipoprotein Cholesterol (LDL-C) target at any time will be collected | Up to 39 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients maintaining the guideline-recommended LDL-C target | Percentage of patients maintaining the guideline-recommended LDL-C target (once achieved) for the duration of the study will be collected | Up to 39 months |
| Time- adjusted percentage change in LDL-C from baseline |
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Inclusion Criteria:
Patients who are 18 years or older.
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).
Heterozygous Familial Hypercholesterolemia (HeFH) patients with documented ASCVD who are eligible for commercially available Leqvio.
Patients who provide written informed consent to participate in the study.
Exclusion Criteria:
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It will consist of adult ASCVD patients and elevated levels of LDL-C with an initial prescription for Leqvio between 01-May-2022 and 31- Dec-2025, who provided written informed consent.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C585830 | ALN-PCS |
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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) |
| Baseline, month 3, month 9, month 15, month 21, month 27, month 33, month 39 |
| Change in LDL-C from baseline stratified on background therapy | Change in LDL-C from baseline stratified on background therapy will be collected | Baseline, up to 39 months |
| Percentage of patients remaining on Inclisiran therapy at each injection visit | Percentage of patients remaining on Inclisiran therapy at each injection visit will be collected | Up to 39 months |
| Percentage of patients with dose changes, switching, discontinuation | Percentage of patients with dose changes, switching or discontinuation will be collected | Up to 39 months |
| Number of ASCVD-related events | Number of atherosclerotic cardiovascular disease (ASCVD)-related events will be collected | Up to 39 months |
| Number of possibly related adverse events | Number of possibly related adverse events will be collected | Up to 39 months |
| Number of injection site reactions | Number of injection site reactions will be collected | Up to 39 months |
| Number of patients with changes in Lp(a) levels for Inclisiran-treated patients | Number of patients with changes in Lipoprotein (a) levels for Inclisiran-treated patients will be collected | Up to 39 months |