Atherosclerotic Cardiovascular DiseaseNCT07023445
Patterns of Inclisiran Use in the Real World: An Analysis of US Databases
An observational study of Atherosclerotic Cardiovascular Disease and Familial Hypercholesterolemia, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease, Familial Hypercholesterolemia
- How many people
- 37,688 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2023to 28 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This was a retrospective, noninterventional cohort study.
Who may be able to join
- 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.
Who cannot join
- Patients with ≥1 prescription claims for the index medications in the 12-month prior-index period (exclusive of index date).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patterns of Inclisiran Use in the Real World: A Retrospective Analysis of US Databases
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.
- Keywords
- Low-density lipoprotein cholesterol, Real-world
- Medical subject headings
- Atherosclerosis, Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Inclisiran Cohort | Patients with a prescription or claim for inclisiran. | |
| Alirocumab Cohort | Patients with a prescription or claim for alirocumab. | |
| Evolocumab Cohort | Patients with a prescription or claim for evolocumab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients per Demographic Category
Demographics included:
- Age group
- Gender
- Insurance type
- Race/ethnicity
Measured: Baseline
Number of Patients per Clinical Characteristic Category
Clinical characteristics included:
- Body mass index
- Atherosclerotic Cardiovascular Disease (ASCVD) diagnosis
- Familial Hypercholesterolemia (FH) diagnosis
- Comorbidities
- Type of lipid lowering therapy (LLT)
Measured: Baseline
Secondary outcomes (4)
Change From Baseline in LDL-C Levels
Measured: From Baseline up to 1 year
Number of Patients who Achieved a Reduction of 50% or more in LDL-C Levels After Initiating Treatment
Measured: Up to 1 year
Number of Patients who Achieved LDL-C Levels Below 70 Milligrams per Deciliter (mg/dL) and 55 mg/dL After Initiating Treatment
Measured: Up to 1 year
Medication Adherence
Adherence was defined using proportion of days covered (PDC) within a period that the patient was persistent: the number of days covered by the prescription fills divided by the number of days between the first fill of the medication during the identification period (index date) and the end of the observational period. A patient was classified as having poor adherence if the calculated PDC was below 80%.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start20 Jan 2023
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 37,688 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023445
- Sponsor's protocol ID
- CKJX839D1US01
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns of Inclisiran Use in the Real World: A Retrospective Analysis of US Databases
- ClinicalTrials.gov ID
- NCT07023445
- Acronym / sponsor ID
- CKJX839D1US01
- Keywords
- Low-density lipoprotein cholesterol, Real-world
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37,688 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inclisiran Cohort | – | –Patients with a prescription or claim for inclisiran. |
| Alirocumab Cohort | – | –Patients with a prescription or claim for alirocumab. |
| Evolocumab Cohort | – | –Patients with a prescription or claim for evolocumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study.
Key inclusion criteria (7 listed)
- 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.
- Patients with at least 6-month or 12-month CE period post-index.
- Patients with continuous use of the index medications.
Key exclusion criteria (1 listed)
- Patients with ≥1 prescription claims for the index medications in the 12-month prior-index period (exclusive of index date).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Patients per Demographic Category
Time frame: Baseline
Demographics included: * Age group * Gender * Insurance type * Race/ethnicity
Number of Patients per Clinical Characteristic Category
Time frame: Baseline
Clinical characteristics included: * Body mass index * Atherosclerotic Cardiovascular Disease (ASCVD) diagnosis * Familial Hypercholesterolemia (FH) diagnosis * Comorbidities * Type of lipid lowering therapy (LLT)
4 secondary outcomes
Change From Baseline in LDL-C Levels
Time frame: From Baseline up to 1 year
Number of Patients who Achieved a Reduction of 50% or more in LDL-C Levels After Initiating Treatment
Time frame: Up to 1 year
Number of Patients who Achieved LDL-C Levels Below 70 Milligrams per Deciliter (mg/dL) and 55 mg/dL After Initiating Treatment
Time frame: Up to 1 year
Medication Adherence
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerotic Cardiovascular Disease and Familial Hypercholesterolemia, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients per Demographic Category (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025; AzTrials last refreshed its copy on 7 Nov 2026.