Recruiting NCT07543731
A Real-World Study of Long-Term Adherence and Persistence to Inclisiran, Evolocumab, and Alirocumab
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cardiovascular Diseases, Atherosclerotic Cardiovascular Disease, Hypercholesterolemia, Familial. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Real-World Long-Term Adherence and Persistence to Inclisiran, Evolocumab, and Alirocumab in Italy
Overview
This study aims to evaluate the long-term adherence and persistence to inclisiran and anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mAbs) in real-world clinical practice.
Primary outcome measures
- Proportion of Days Covered (PDC) With Inclisiran [Time frame: 6 months after index date and every 3 months thereafter until the end of follow-up, assessed up to 48 months]
- Annual PDC With Inclisiran [Time frame: 0-12 months, 12-24 months, 24-48 months]
- Persistence With Inclisiran Treatment [Time frame: 6 months after index date and every 3 months thereafter until the end of follow-up, assessed up to 48 months]
Secondary outcome measures (12)
- PDC With Anti-PCSK9-mAbs [Time frame: 6 months after index date and every 3 months thereafter until the end of follow-up, assessed up to 48 months]
- Annual PDC With Anti-PCSK9-mAbs [Time frame: 0-12 months, 12-24 months, 24-48 months]
- Persistence With Anti-PCSK9-mAb Treatment [Time frame: 6 months after index date and every 3 months thereafter until the end of follow-up, assessed up to 48 months]
- Baseline Demographics [Time frame: Baseline]
- Baseline Clinical Characteristics: Number of Patients by Diagnosis [Time frame: Baseline]
- Baseline Clinical Characteristics: Number of Patients by Comorbidity [Time frame: Baseline]
- Baseline Clinical Characteristics: Charlson Comorbidity Index (CCI) Score [Time frame: Baseline]
- PDC With Lipid Lowering Therapies (LLTs) at Baseline [Time frame: Baseline]
- Number of Patients by LLTs Received [Time frame: Every 3 months from baseline through index date until the end of follow-up, assessed up to 48 months]
- Number and Percentage of Patients Receiving Each of the Inclisiran Doses [Time frame: From index date until the end of follow-up, assessed up to 48 months]
- Time Between Inclisiran Doses [Time frame: From index date until the end of follow-up, assessed up to 48 months]
- Number of Anti-PCSK9-mAb Prescriptions [Time frame: From index date until the end of follow-up, assessed up to 48 months]
Eligibility criteria
Inclusion criteria
- A first ever prescription of injection of inclisiran, evolocumab, or alirocumab during the identification period.
- Age ≥18 years at index date.
- With at least 12 months data availability prior to index date.
Exclusion criteria
- Patients who received either evolocumab or alirocumab as their index study drug and who were dispensed the other anti-PCSK9-mAb (alirocumab and evolocumab respectively) before the identification period.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Switzerland · 1 center
- Novartis — Basel
Identifiers
NCT: NCT07543731 · CKJX839A12404