Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
- Conditions
- Primary HypercholesterolemiaMixed Dyslipidemia
- Interventions
- Other: Inclisiran
- Registration Number
- NCT05399992
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This observational prospective study aims to evaluate the LDL-C change and adherence to inclisiran in combination with other LLTs under conditions of routine clinical practice.
- Detailed Description
Patients will be enrolled over a period of \~31.5 months, and followed for up to 24 months to assess for study outcomes.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 855
- Participants who are 18 years or older
- Participants with hypercholesterolemia having a diagnosis of ASCVD, ASCVD RE or HeFH
- Participants who are not at LDL-C goal as per their CV risk according to respective clinical guidelines
- Participants who per physician's criteria need to optimize their LLT
- Participants who provide written informed consent to participate in the study
- Participants who initiate inclisiran under conditions per local label and have LDL-C values available at baseline or within 3 months before treatment initiation.
- Participants that have received inclisiran previously
- Participants participating in a clinical trial with investigational product 3 Participants switching from previous PCSK9 mab treatment (within 90 days prior to Index date
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Inclisiran cohort Inclisiran Participants prescribed inclisiran in combination with Standard of Care (SoC)
- Primary Outcome Measures
Name Time Method Percentage change in LDL-C from baseline to 10 months Baseline, 10 months Percentage change in Low density lipoprotein - Cholesterol (LDL-C)
- Secondary Outcome Measures
Name Time Method Percentage change in LDL-C from baseline Baseline, month 4, month 16, month 22 Percentage change in LDL-C from baseline is collected
Percentage change in LDL-C from baseline by ≥50% Month 4, month 10, month 16, month 22 Percentage change in LDL-C from baseline by ≥50%
Percentage change in LDL-C from baseline by ≥30% Month 4, month 10, month 16, month 22 Percentage change in LDL-C from baseline by ≥30%
Inclisiran cohort : Mean PDC 12 months and 24 months Mean Proportion of Days Covered (PDC) for inclisiran cohort is collected
Proportion of participants remaining on initial baseline therapy Baseline, month 12 and month 24 Proportion of patients remaining on initial baseline therapy in the inclisiran cohort
Change from baseline in scores from the TSQM (modified) instrument Baseline, month 12 and month 24 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.Descriptive adherence data based on Adherence AAQ Month 12 and month 24 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).Descriptive adherence data based on ABQ Month 12 and month 24 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.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇬🇧Middlesex, United Kingdom