NCT07023445Completed
Patterns of Inclisiran Use in the Real World: An Analysis of US Databases
Patterns of Inclisiran Use in the Real World: A Retrospective Analysis of US Databases
Source: ClinicalTrials.gov · Last updated 17 Jun 2025
Brief summary (registry, in English)
This was a retrospective observational cohort study of patients who initiated inclisiran, alirocumab, or evolocumab in a real-world setting in the United States. The study used data extracted from three databases: (1) open and closed claims from Komodo's Healthcare map and electronic medical records (EMRs) from outpatient clinics affiliated with (2) Healix and (3) Metro Infusion Centers. The study period spanned from 01 January 2021 to the latest date of the available data for each database. Index date was defined as the date of the first claim for inclisiran, alirocumab, or evolocumab within the patient identification period. The 12-month period prior to the index date (including the index date) was the baseline period. Follow-up spanned from the index date up to patient disenrollment, death, or the end of the study period, whichever came first.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 37688 (actual)
- First submitted
- 10 Jun 2025
- Start date
- 20 Jan 2023
- Primary completion date
- 28 Jun 2024
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT07023445
What you commit to
- Study type: Observational
- Participants enrolled: 37688
- From 20 Jan 2023 to the primary completion date, 28 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with ≥1 prescription claims for the index medications in the 12-month prior-index period (exclusive of index date).
Who the study is looking for
- Patients with a first claim for inclisiran within the identification period.
- Patients without a claim for inclisiran and with a first alirocumab claim or first evolocumab claim within the identification period.
- Patients with 12 months of continuous enrollment (CE) before index, inclusive of index date.
- Additional inclusion criteria for secondary outcome measures:
- Patients with at least 6-month or 12-month CE period post-index.
- Patients with continuous use of the index medications.
- Patients with available low-density lipoprotein cholesterol (LDL-C) measurements at baseline and after treatment initiation.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novartis Coordinator of this site? Confirm its status | East Hanover | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.