Cardiovascular DiseasesVICTORION-LEAPNCT07543731
A Real-World Study of Long-Term Adherence and Persistence to Inclisiran, Evolocumab, and Alirocumab
An observational study of Cardiovascular Diseases and Atherosclerotic Cardiovascular Disease, run by Novartis Pharmaceuticals at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cardiovascular Diseases, Atherosclerotic Cardiovascular Disease, Hypercholesterolemia, Familial
- Type of treatment
- Injection or infusion
- How many people
- 5,995 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Apr 2026to 30 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients in Italy who initiated inclisiran, evolocumab, or alirocumab treatment during the identification period with at least 18 months of follow-up.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
About this study
Official title: Real-World Long-Term Adherence and Persistence to Inclisiran, Evolocumab, and Alirocumab in Italy
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.
- Conditions
- Cardiovascular Diseases, Atherosclerotic Cardiovascular Disease, Hypercholesterolemia, Familial
- Keywords
- Real-world, Retrospective, Adherence, Persistence, Long-term, PCSK9i
- Medical subject headings
- Cardiovascular Diseases, 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 receiving inclisiran injection(s). | |
| Evolocumab Cohort | Patients receiving evolocumab injection(s). | |
| Alirocumab Cohort | Patients receiving alirocumab injection(s). | |
| Pooled Anti-PCSK9-mAb Cohort | Patients receiving anti-PCSK9-mAbs either evolocumab or alirocumab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Days Covered (PDC) With Inclisiran
PDC is defined as the number of days with medication supply (covered days) within a period of interest divided by the number of days in the period of interest. Index date is the date of first use of the treatment.
Measured: 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
PDC is defined as the number of days with medication supply (covered days) within a period of interest divided by the number of days in the period of interest.
Measured: 0-12 months, 12-24 months, 24-48 months
Persistence With Inclisiran Treatment
Persistence is defined as time to discontinuation by exceeding a pre-specified allowable gap beyond the scheduled time for the next dose/prescription. Index date is the date of first use of the treatment.
Measured: 6 months after index date and every 3 months thereafter until the end of follow-up, assessed up to 48 months
Secondary outcomes (15)
PDC With Anti-PCSK9-mAbs
PDC is defined as the number of days with medication supply (covered days) within a period of interest divided by the number of days in the period of interest. Index date is the date of first use of the treatment.
Measured: 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
PDC is defined as the number of days with medication supply (covered days) within a period of interest divided by the number of days in the period of interest.
Measured: 0-12 months, 12-24 months, 24-48 months
Persistence With Anti-PCSK9-mAb Treatment
Persistence is defined as time to discontinuation by exceeding a pre-specified allowable gap beyond the scheduled time for the next dose/prescription. Index date is the date of first use of the treatment.
Measured: 6 months after index date and every 3 months thereafter until the end of follow-up, assessed up to 48 months
Baseline Demographics
Measured: Baseline
Baseline Clinical Characteristics: Number of Patients by Diagnosis
Diagnoses include primary hypercholesterolemia, mixed dyslipidemia, homozygous familial hypercholesterolemia, and atherosclerotic cardiovascular disease (ASCVD) where available.
Measured: Baseline
Baseline Clinical Characteristics: Number of Patients by Comorbidity
Measured: Baseline
Baseline Clinical Characteristics: Charlson Comorbidity Index (CCI) Score
CCI is a weighted index that takes into account both the number and the seriousness of comorbid diseases. It predicts the ten-year mortality for a patient who may have a range of comorbid conditions. CCI can be categorized as low (0-1) and high (≥2).
Measured: Baseline
PDC With Lipid Lowering Therapies (LLTs) at Baseline
PDC is defined as the number of days with medication supply (covered days) within a period of interest divided by the number of days in the period of interest.
Measured: Baseline
Number of Patients by LLTs Received
Treatment patterns of LLT use. Index date is the date of first use of the treatment.
Measured: 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
Index date is the date of first use of the treatment.
Measured: From index date until the end of follow-up, assessed up to 48 months
Time Between Inclisiran Doses
Index date is the date of first use of the treatment.
Measured: From index date until the end of follow-up, assessed up to 48 months
Number of Anti-PCSK9-mAb Prescriptions
Index date is the date of first use of the treatment.
Measured: From index date until the end of follow-up, assessed up to 48 months
Time Between Anti-PCSK9-mAb Prescriptions
Index date is the date of first use of the treatment.
Measured: From index date until the end of follow-up, assessed up to 48 months
Association Between Treatment Adherence and Baseline Characteristics per Cohort
Multivariable regression models will be used to examine how baseline characteristics could be associated with treatment adherence per cohort. Baseline characteristics may include age, sex, diagnosis, cardiovascular events, comorbidities, adherence to LLTs, and number of medications received at index and post-index.
Measured: Baseline, up to 48 months
Association Between Treatment Persistence and Baseline Characteristics per Cohort
Cox proportional hazards models will be used to examine how baseline characteristics could be associated with treatment persistence per cohort. Baseline characteristics may include age, sex, diagnosis, cardiovascular events, comorbidities, adherence to LLTs, and number of medications received at index and post-index.
Measured: Baseline, up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start2 Apr 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- 5,995 participants (estimated)
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
- NCT07543731
- Sponsor's protocol ID
- CKJX839A12404
- Acronym
- VICTORION-LEAP
- Status last verified
- Jul 2026
- First submitted
- 14 Apr 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Long-Term Adherence and Persistence to Inclisiran, Evolocumab, and Alirocumab in Italy
- ClinicalTrials.gov ID
- NCT07543731
- Acronym / sponsor ID
- VICTORION-LEAP / CKJX839A12404
- Conditions
- Cardiovascular Diseases, Atherosclerotic Cardiovascular Disease, Hypercholesterolemia, Familial
- Keywords
- Real-world, Retrospective, Adherence, Persistence, Long-term, PCSK9i
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,995 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 22 Apr 2026 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Inclisiran Cohort | – | –Patients receiving inclisiran injection(s). |
| Evolocumab Cohort | – | –Patients receiving evolocumab injection(s). |
| Alirocumab Cohort | – | –Patients receiving alirocumab injection(s). |
| Pooled Anti-PCSK9-mAb Cohort | – | –Patients receiving anti-PCSK9-mAbs either evolocumab or alirocumab. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients in Italy who initiated inclisiran, evolocumab, or alirocumab treatment during the identification period with at least 18 months of follow-up.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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
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
PDC is defined as the number of days with medication supply (covered days) within a period of interest divided by the number of days in the period of interest. Index date is the date of first use of the treatment.
Annual PDC With Inclisiran
Time frame: 0-12 months, 12-24 months, 24-48 months
PDC is defined as the number of days with medication supply (covered days) within a period of interest divided by the number of days in the period of interest.
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
Persistence is defined as time to discontinuation by exceeding a pre-specified allowable gap beyond the scheduled time for the next dose/prescription. Index date is the date of first use of the treatment.
15 secondary outcomes
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
Time Between Anti-PCSK9-mAb Prescriptions
Time frame: From index date until the end of follow-up, assessed up to 48 months
Association Between Treatment Adherence and Baseline Characteristics per Cohort
Time frame: Baseline, up to 48 months
Association Between Treatment Persistence and Baseline Characteristics per Cohort
Time frame: Baseline, up to 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Novartis Pharmaceuticals contact
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 Cardiovascular Diseases and Atherosclerotic Cardiovascular Disease, run by Novartis Pharmaceuticals at 1 site in Switzerland.
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 3 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: looking for participants now, as of the sponsor's last update on 15 Jul 2026. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 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 15 Jul 2026; AzTrials last refreshed its copy on 3 Nov 2026.