Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD

N/AActive Not RecruitingNCT05399992

Novartis Pharmaceuticals847 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

847

Conditions

Primary Hypercholesterolemia Mixed Dyslipidemia

Interventions

InclisiranOTHER

Prospective observational study. There is no treatment allocation. Patients who are eligible to receive inclisiran will be enrolled into this study.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Participants who are 18 years or older 2. Participants with hypercholesterolemia having a diagnosis of ASCVD, ASCVD RE or HeFH 3. Participants who are not at LDL-C goal as per their CV risk according to respective clinical guidelines 4. Participants who per physician's criteria need to optimize their LLT 5. Participants who provide written informed consent to participate in the study 6. Participants who initiate inclisiran under conditions per local label and have LDL-C values available at baseline or within 3 months before treatment initiation. Exclusion Criteria: 1. Participants that have received inclisiran previously 2. Participants participating in a clinical trial with investigational product 3 Participants switching from previous PCSK9 mab treatment (within 90 days prior to Index date)

Locations (40)

Outcomes

Primary Outcomes

Percentage change in LDL-C from baseline to 10 months

Percentage change in Low density lipoprotein - Cholesterol (LDL-C)

Time frame: Baseline, 10 months

Secondary Outcomes

Percentage change in LDL-C from baseline

Percentage change in LDL-C from baseline is collected

Time frame: Baseline, month 4, month 16, month 22

Percentage change in LDL-C from baseline by ≥50%

Time frame: Month 4, month 10, month 16, month 22

Percentage change in LDL-C from baseline by ≥30%

Time frame: 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

Time frame: 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

Time frame: Month 4, month 10, month 16 and month 22

Time-averaged percentage change in LDL-C from baseline

Time frame: 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

Data from ClinicalTrials.gov

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Novartis Investigative Site

Feldkirch, Austria

Novartis Investigative Site

Graz, Austria

Novartis Investigative Site

Linz, Austria

Novartis Investigative Site

Sankt Veit im Pongau, Austria

Novartis Investigative Site

Vienna, Austria

Novartis Investigative Site

Vienna, Austria

Novartis Investigative Site

Shenzhen, Guangdong, China

Novartis Investigative Site

Holon, Gush Dan, Israel

Novartis Investigative Site

Petah Tikva, Israel

Novartis Investigative Site

Tel Aviv, Israel

...and 30 more locations

Proportion of participants achieving ≥50% reduction in LDL C at month 10 and maintaining this at 16, 22 and 24 months

Time frame: 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

Time frame: 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

Time frame: Month 10 and month 24

Inclisiran cohort : Percentage of days covered by inclisiran

Time frame: 12 months and 24 months

Inclisiran cohort : Mean PDC

Mean Proportion of Days Covered (PDC) for inclisiran cohort is collected

Time frame: 12 months and 24 months

Inclisiran cohort : Proportion of participants with a PDC ≥ 80%

Proportion of participants with a PDC ≥ 80% (sensitivity: 90%/100%)

Time frame: 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

Time frame: Baseline, month 12 and month 24

Time to discontinuation of any newly initiated therapies

Time frame: Month 12 and month 24

Time to discontinuation of any newly initiated therapies by specific LLT

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: Month 12 and month 24