Long-term use of inclisiran, evolocumab, and alirocumab in real-world care
Official title: Real-World Long-Term Adherence and Persistence to Inclisiran, Evolocumab, and Alirocumab in Italy
Run by Novartis · NCT07543731 · Data updated 2026-11-12
This study tests whether people with high cholesterol medications stick with their PCSK9 inhibitors and inclisiran over the long term in everyday clinical practice.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 5995 (estimated) |
| Sponsor | Novartis Industry-sponsored |
| Drugs / interventions | evolocumab, alirocumab |
| Locations | 1 site (Basel) |
| Status | Recruiting |
| Started | April 2, 2026 |
| Main results expected | October 30, 2026 |
| Study ends | October 30, 2026 |
| Registry record updated | July 15, 2026 |
| Trial ID | NCT07543731 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older starting inclisiran or a PCSK9 inhibitor (evolocumab or alirocumab) for the first time, with at least 12 months of prior data available.
✕Probably not a fit
Patients who do not have long-term follow-up data or who switch between anti-PCSK9 therapies during the study period may not benefit from findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study examines real-world patterns of adherence and persistence to inclisiran and anti-PCSK9 monoclonal antibodies (evolocumab and alirocumab) among adults with cardiovascular disease and related conditions. It uses retrospective data to identify patients at their first prescription and tracks their medication use for an extended period after initiation. The goal is to understand how consistently patients continue treatment over time and what factors might influence persistence. No interventions are assigned; the study relies on existing prescription records to observe natural treatment patterns. Eligibility requires adults with at least 12 months of prior data and no prior exposure to the comparator anti-PCSK9 mAb before the identification period.
Why it matters
Potential benefit: Findings could inform clinicians about real-world persistence with PCSK9 inhibitors and inclisiran, potentially guiding patient management and adherence support.
How similar studies have gone: Prior real-world studies have shown mixed adherence with PCSK9 inhibitors; this study adds long-term, observational data in routine practice.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Novartis
Basel, Switzerland Recruiting
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +41613241111
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.