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This observational prospective study aims to evaluate the LDL-C change and adherence to inclisiran in combination with other lipid lowering therapies or lipid lowering treatments (LLTs) under conditions of routine clinical practice.
Patients will be enrolled over a period of 23 months, and followed for up to 24 months to assess for study outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inclisiran cohort | Participants prescribed inclisiran alone or with other LLTs as per approved label |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inclisiran | Other | Prospective observational study. There is no treatment allocation. Patients who are eligible to receive inclisiran will be enrolled into this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in LDL-C from baseline to 10 months | Percentage change in Low density lipoprotein - Cholesterol (LDL-C) | Baseline, 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in LDL-C from baseline | Percentage change in LDL-C from baseline is collected | Baseline, month 4, month 16, month 22 |
| Percentage change in LDL-C from baseline by ≥50% | Percentage change in LDL-C from baseline by ≥50% |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of adult participants with an underlying diagnosis of Atherosclerotic Cardiovascular Disease (ASCVD), ASCVD risk equivalent (ASCVD RE), or Heterozygous familial hypercholesterolemia (HeFH) and elevated levels of Low density lipoprotein - Cholesterol (LDL-C)
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Feldkirch | 6807 | Austria | |||
| Novartis Investigative Site |
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| Month 4, month 10, month 16, month 22 |
| Percentage change in LDL-C from baseline by ≥30% | Percentage change in LDL-C from baseline by ≥30% | Month 4, month 10, month 16, month 22 |
| Proportion of participants achieving LDL-C<55 mg/dL | Proportion of participants achieving LDL-C<55 mg/dL | Proportion of participants achieving LDL-C<55 mg/dL Month 4, month 10, month 16 and month 22 |
| Proportion of participants achieving LDL-C<70 mg/dL | Proportion of participants achieving LDL-C<70 mg/dL | Month 4, month 10, month 16 and month 22 |
| Time-averaged percentage change in LDL-C from baseline | Time-averaged percentage change in LDL-C from baseline | Baseline, month 4, month 10, month 16 and month 22 |
| Proportion of participants achieving ≥50% reduction in LDL- C at month 10 and maintaining this at 16, 22 and 24 months | Proportion of participants achieving ≥50% reduction in LDL C at month 10 and maintaining this at 16, 22 and 24 months | Month 10, month 16, month 22 and month 24 |
| Proportion of participants achieving ≥30% reduction in LDL C from baseline to 10 months and maintaining until 24 months | Proportion of participants achieving ≥30% reduction in LDL C from baseline to 10 months and maintaining until 24 months | Baseline, month 10, month 24 |
| Proportion of participants achieving <55 mg/dL and <70 mg/dL in LDL-C at 10 months and maintaining until 24 months | Proportion of participants achieving <55 mg/dL and <70 mg/dL in LDL-C at 10 months and maintaining until 24 months | Month 10 and month 24 |
| Inclisiran cohort : Percentage of days covered by inclisiran | Inclisiran cohort : Percentage of days covered by inclisiran | 12 months and 24 months |
| Inclisiran cohort : Mean PDC | Mean Proportion of Days Covered (PDC) for inclisiran cohort is collected | 12 months and 24 months |
| Inclisiran cohort : Proportion of participants with a PDC ≥ 80% | Proportion of participants with a PDC ≥ 80% (sensitivity: 90%/100%) | 12 months and 24 months |
| Proportion of participants remaining on initial baseline therapy | Proportion of patients remaining on initial baseline therapy in the inclisiran cohort | Baseline, month 12 and month 24 |
| Time to discontinuation of any newly initiated therapies | Time to discontinuation of any newly initiated therapies | Month 12 and month 24 |
| Time to discontinuation of any newly initiated therapies by specific LLT | Time to discontinuation of any newly initiated therapies by specific LLT | Month 12 and month 24 |
| Change from baseline in scores from the TSQM (modified) instrument | The 14-item Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 is an instrument to assess patients' satisfaction with medication, providing scores on four scales - side effects, effectiveness, convenience and global satisfaction. TSQM V1.4 has a score range of 0 to 100 with with higher scores indicating higher patient satisfaction with medication. | Baseline, month 12 and month 24 |
| Descriptive adherence data based on Adherence AAQ | Adherence Assessment Questionnaires (AAQ) measures the degree of identified non-adherence to LLT therapy. AAQ has a score range from 0 (not adherent at all) to 100 (absolute adherent). | Month 12 and month 24 |
| Descriptive adherence data based on ABQ | Adherence Barriers Questionnaire (ABQ) is an instrument for identifying specific barriers to medication-related adherence. ABQ is a descriptive analysis. The number and proportion of patients affected by each barrier will be reported for inclisiran participants. | Month 12 and month 24 |
| Graz |
| 8036 |
| Austria |
| Novartis Investigative Site | Linz | 4021 | Austria |
| Novartis Investigative Site | Sankt Veit im Pongau | 5621 | Austria |
| Novartis Investigative Site | Vienna | 1090 | Austria |
| Novartis Investigative Site | Vienna | 1180 | Austria |
| Novartis Investigative Site | Shenzhen | Guangdong | 518000 | China |
| Novartis Investigative Site | Holon | Gush Dan | 5845997 | Israel |
| Novartis Investigative Site | Petah Tikva | 4941492 | Israel |
| Novartis Investigative Site | Tel Aviv | 6801296 | Israel |
| Novartis Investigative Site | Kuala Lumpur | Kuala Lumpur | 50470 | Malaysia |
| Novartis Investigative Site | Kuala Lumpur | 50400 | Malaysia |
| Novartis Investigative Site | Riyadh | Saudi | 11643 | Saudi Arabia |
| Novartis Investigative Site | Jeddah | 23311 | Saudi Arabia |
| Novartis Investigative Site | Tabuk | 47512 | Saudi Arabia |
| Novartis Investigative Site | Fribourg | CH | 1708 | Switzerland |
| Novartis Investigative Site | Basel | 4031 | Switzerland |
| Novartis Investigative Site | Geneva | 1211 | Switzerland |
| Novartis Investigative Site | Lausanne | 1011 | Switzerland |
| Novartis Investigative Site | Olten | 4600 | Switzerland |
| Novartis Investigative Site | Sankt Gallen | 9007 | Switzerland |
| Novartis Investigative Site | Zurich | 8032 | Switzerland |
| Novartis Investigative Site | Zurich | 8091 | Switzerland |
| Novartis Investigative Site | Abu Dhabi | Abu Dhabi Emirate | 00000 | United Arab Emirates |
| Novartis Investigative Site | Dubai | United Arab Emirates | 7272 | United Arab Emirates |
| Novartis Investigative Site | Abu Dhabi | United Arab Emirates |
| Novartis Investigative Site | Al Ain City | United Arab Emirates |
| Novartis Investigative Site | Dubai | United Arab Emirates |
| Novartis Investigative Site | High Wycombe | Buckinghamshire | HP11 2TR | United Kingdom |
| Novartis Investigative Site | Louth | Lincolnshire | LN11 7QU | United Kingdom |
| Novartis Investigative Site | Sunderland | Tyne and Wear | SR4 7TP | United Kingdom |
| Novartis Investigative Site | Belfast | BT16 1RH | United Kingdom |
| Novartis Investigative Site | Bromwich | B71 4HJ | United Kingdom |
| Novartis Investigative Site | Burton-on-Trent | DE13 0RB | United Kingdom |
| Novartis Investigative Site | Cardiff | CF14 4XW | United Kingdom |
| Novartis Investigative Site | Hull | HU3 2RW | United Kingdom |
| Novartis Investigative Site | Lancaster | LA1 4RP | United Kingdom |
| Novartis Investigative Site | Liverpool | L7 8XP | United Kingdom |
| Novartis Investigative Site | London | NW3 2QG | United Kingdom |
| Novartis Investigative Site | Middlesex | UB9 6JH | United Kingdom |
| ID | Term |
|---|---|
| C585830 | ALN-PCS |
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