Atherosclerotic Cardiovascular DiseasePhase 4V-INCLUSIONNCT06249165
VictORION-INCLUSION: Evaluating Inclisiran for Cholesterol Managment in Heart Disease
A Phase 4 study testing Inclisiran in people with Atherosclerotic Cardiovascular Disease, run by Duke University at 23 sites in United States.
Trial summary
VictORION-INCLUSION (V-INCLUSION) seeks to evaluate the effectiveness of inclisiran as an innovative therapy with the potential to help bridge care gaps in historically understudied and undertreated populations by leveraging electronic health records (EHR) in multiple US Healthcare Systems (HCS) to systematically… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease
- What is being tested?
- Inclisiran
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 23 sitesUnited States
- Study dates
- 16 Dec 2024to 28 Feb 2027
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females >= 18 years of age
- Have clinical ASCVD or ASCVD risk equivalent diagnosis captured in EHR
- Serum LDL-C ≥ 70 mg/dL for participants with ASCVD, or LDL-C ≥ 100 mg/dL for ASCVD risk equivalent participants, based on last recorded LDL-C value within the preceding eighteen (18) months without a subsequent change in lipid lowering therapy.
- Willing and able to give informed consent before initiation of any study related procedures and willing to comply with all required study procedures.
- On statin therapy, or have documented statin intolerance, as determined by the treating clinician. Participants for whom statin therapy has been recently initiated must be on stable therapy for at least 4 weeks and subsequent LDL-C must be above the threshold.
- From historically underrepresented populations in cardiovascular clinical research, including at least one of the following: female sex; Hispanic/Latino ethnicity; Black/African-American, Asian, or Native American race; rural dwelling based on the HRSA definition for determining rural grant eligibility using the Federal Office of Rural Health Policy (FORHP) 2010 County and Census Tract file.
Who cannot join
- Planned use of other investigational products or devices during the course of the study.
- Treatment with monoclonal antibodies directed towards PCSK9 within 90 days or with inclisiran within 180 days of pre-screening.
- History of hypersensitivity to the study treatment or its excipients or to other siRNA drugs.
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception during dosing of study treatment.
- New York Heart Association (NYHA) class III or IV heart failure or last known left ventricular ejection fraction <25%.
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- Significant cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or other methods (i.e. via ablation etc.) at the time of pre-screening. Controlled arrhythmia is not an exclusion.
- Uncontrolled hypertension: systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg prior to randomization despite antihypertensive therapy.
- Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or alanine aminotransferase (ALT) elevation >3x ULN, aspartate aminotransferase (AST) elevation >3x ULN, or total bilirubin elevation >2x ULN (except participants with Gilbert's syndrome) at pre-screening confirmed by a repeat measurement at least one week apart. Lack of repeat measurement is not considered an exclusion.
- End-stage renal disease (ESRD), defined as being on dialysis of any kind.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Emory University
Atlanta, Georgia, 30324
JHU - Suburban Hospital
Bethesda, Maryland, 20814
Univ. of Alabama - Birmingham
Birmingham, Alabama, 35205
University of North Carolina
Chapel Hill, North Carolina, 27514
Medical Univ. of South Carolina
Charleston, South Carolina, 29403
Rush University
Chicago, Illinois, 60612
Johns Hopkins
Columbia, Maryland, 21044
University of Missouri
Columbia, Missouri, 65212
Essentia Health
Duluth, Minnesota, 55805
Duke University Medical Center
Durham, North Carolina, 27710
Heart House of NJ
Haddon Heights, New Jersey, 08035
Wellstar Paulding
Hiram, Georgia, 30141
Houston Methodist
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Nebraska
Omaha, Nebraska, 68198
Univ. of California - Irvine
Orange, California, 92868
Temple University
Philadelphia, Pennsylvania, 19140
University of Utah
Salt Lake City, Utah, 84132
San Francisco General Hospital
San Francisco, California, 94110
Washington University
St Louis, Missouri, 63110
Baylor Scott & White - Waco
Waco, Texas, 76708
Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: VictORION-INCLUSION: Evaluating INClisiran as a soLUtion to Improve LDL-C Management and cloSe Care Gaps in an Inclusive ASCVD and ASCVD Risk Equivalent populatiON
VictORION-INCLUSION (V-INCLUSION) seeks to evaluate the effectiveness of inclisiran as an innovative therapy with the potential to help bridge care gaps in historically understudied and undertreated populations by leveraging electronic health records (EHR) in multiple US Healthcare Systems (HCS) to systematically identify those at high risk for and already diagnosed with ASCVD for more expeditious achievement of LDL-C targets.
Read the detailed description
The trial consists of two parts. Part 1 is a randomized, controlled, multicenter, open-label two arm trial comparing inclisiran and usual care versus usual care alone in an inclusive study population identified by electronic health records. Part 2 is a single arm trial consisting of Part 1 usual care participants initiating inclisiran at Day 360, and receiving two additional doses on day 450 and 630 (dosed in similar fashion to inclisiran + UC arm in Part 1). Approximately 1440 participants will be randomized to either inclisiran + usual care or to usual care only. Eligible participants must be at high risk for or be diagnosed with established ASCVD (prior CAD, PAD, CeVD event) and LDL-C above treatment threshold despite treatment with statin therapy (or with documented statin intolerance).
The study funder made a business decision to close the study to enrollment. Any patients identified and confirmed eligible prior to May 30, 2025 were permitted to be randomized through June 6, 2025. A total of 130 participants were enrolled. Participants randomized to Inclisiran + Usual Care will complete the study as originally planned. Participants randomized to Usual Care alone will have the option to receive inclisiran earlier if they choose to do so. They may also opt to complete only the Usual Care portion of the study (i.e., never receive study inclisiran) or to withdraw from the study. Usual Care participants will be required to sign an addendum to consent to these changes and identify their selection.
The study population will consist of underrepresented and historically understudied male and female participants (targeting 50% female, 70% underrepresented [Black/African American, Hispanic/Latino, Asian, other] and 10% rural participants of any sex or race/ethnicity) ≥18 years of age with a history of ASCVD (coronary artery disease, ischemic cerebrovascular disease or peripheral arterial disease) or ASCVD risk equivalent (HeFH, Type 2 DM, or 10 year ASCVD risk score ≥ 20%) who have elevated LDL-C (≥ 70 mg/dL or LDL-C ≥ 100 mg/dL) respectively) despite being treated with statin therapy. A total of approximately 1440 participants will be randomized to inclisiran + usual care or usual care in a 1:1 ratio at up to 30 US healthcare systems.
- Conditions
- Atherosclerotic Cardiovascular Disease
- Being tested
- Inclisiran
- Keywords
- Hyperlipidemia, Secondary Cardiovascular Prevention, Primary Prevention, Atherosclerotic Cardiovascular Disease (ASCVD), Hypercholesterolemia, Lipid lowering therapies, Inclisiran
- Medical subject headings
- Atherosclerosis, Hyperlipidemias, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InclisiranDrug
Also called Leqvio
Inclisiran sodium 300 mg/1.5 ml (equivalent to 284 mg inclisiran liquid) in prefilled syringe (PFS).
| Study group | Role | What they receive |
|---|---|---|
| Inclisiran | Experimental | Inclisiran + Usual Care Receives: Drug: Inclisiran |
| Usual Care | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of LDL-C targets
Achieving LDL-C targets (LDL-C < 70 mg/dL for ASCVD participants or LDL-C < 100 for ASCVD risk equivalent participants) (yes/no)
Measured: Day 360
Secondary outcomes (4)
Achievement of LDL-C targets by subgroup
Achieving LDL-C targets at Day 360 in the following participant subgroups: Female, Black/African American, Hispanic/Latino, Rural.
Measured: Day 360
Change in LDL-C from baseline by population
Change in LDL-C value from baseline (absolute change, percent change, average absolute change, average percent change) in entire population, ASCVD population, and ASCVD risk equivalent population
Measured: Day 360
Achievement of LDL-C targets by population
Achieving LDL-C target at day 360 in ASCVD population and ASCVD risk equivalent population
Measured: Day 360
Safety and tolerability of inclisiran
Incidence of AEs and SAEs
Measured: Through study completion, up to approximately 630 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start16 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
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 Duke UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, controlled, multicenter, open-label two arm trial
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Neha Pagidipati, MD, Principal investigator, Duke Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249165
- Sponsor's protocol ID
- Pro00115658
- Other IDs
- CKJX839A1US10
- Acronym
- V-INCLUSION
- Status last verified
- Jul 2026
- First submitted
- 31 Jan 2024
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VictORION-INCLUSION: Evaluating INClisiran as a soLUtion to Improve LDL-C Management and cloSe Care Gaps in an Inclusive ASCVD and ASCVD Risk Equivalent populatiON
- ClinicalTrials.gov ID
- NCT06249165
- Acronym / sponsor ID
- V-INCLUSION / Pro00115658
- Conditions
- Atherosclerotic Cardiovascular Disease
- Keywords
- Hyperlipidemia, Secondary Cardiovascular Prevention, Primary Prevention, Atherosclerotic Cardiovascular Disease (ASCVD), Hypercholesterolemia, Lipid lowering therapies, Inclisiran
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 8 Feb 2024 (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.
VictORION-INCLUSION (V-INCLUSION) seeks to evaluate the effectiveness of inclisiran as an innovative therapy with the potential to help bridge care gaps in historically understudied and undertreated populations by leveraging electronic health records (EHR) in multiple US Healthcare Systems (HCS) to systematically identify those at high risk for and already diagnosed with ASCVD for more expeditious achievement of LDL-C targets.
Detailed description
The trial consists of two parts. Part 1 is a randomized, controlled, multicenter, open-label two arm trial comparing inclisiran and usual care versus usual care alone in an inclusive study population identified by electronic health records. Part 2 is a single arm trial consisting of Part 1 usual care participants initiating inclisiran at Day 360, and receiving two additional doses on day 450 and 630 (dosed in similar fashion to inclisiran + UC arm in Part 1). Approximately 1440 participants will be randomized to either inclisiran + usual care or to usual care only. Eligible participants must be at high risk for or be diagnosed with established ASCVD (prior CAD, PAD, CeVD event) and LDL-C above treatment threshold despite treatment with statin therapy (or with documented statin intolerance).
The study funder made a business decision to close the study to enrollment. Any patients identified and confirmed eligible prior to May 30, 2025 were permitted to be randomized through June 6, 2025. A total of 130 participants were enrolled. Participants randomized to Inclisiran + Usual Care will complete the study as originally planned. Participants randomized to Usual Care alone will have the option to receive inclisiran earlier if they choose to do so. They may also opt to complete only the Usual Care portion of the study (i.e., never receive study inclisiran) or to withdraw from the study. Usual Care participants will be required to sign an addendum to consent to these changes and identify their selection.
The study population will consist of underrepresented and historically understudied male and female participants (targeting 50% female, 70% underrepresented [Black/African American, Hispanic/Latino, Asian, other] and 10% rural participants of any sex or race/ethnicity) ≥18 years of age with a history of ASCVD (coronary artery disease, ischemic cerebrovascular disease or peripheral arterial disease) or ASCVD risk equivalent (HeFH, Type 2 DM, or 10 year ASCVD risk score ≥ 20%) who have elevated LDL-C (≥ 70 mg/dL or LDL-C ≥ 100 mg/dL) respectively) despite being treated with statin therapy. A total of approximately 1440 participants will be randomized to inclisiran + usual care or usual care in a 1:1 ratio at up to 30 US healthcare systems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized, controlled, multicenter, open-label two arm trial
| Arm | Type | Receives |
|---|---|---|
| Inclisiran | Experimental | Drug: InclisiranInclisiran + Usual Care |
| Usual Care | No intervention | –Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females >= 18 years of age
- Have clinical ASCVD or ASCVD risk equivalent diagnosis captured in EHR
- Serum LDL-C ≥ 70 mg/dL for participants with ASCVD, or LDL-C ≥ 100 mg/dL for ASCVD risk equivalent participants, based on last recorded LDL-C value within the preceding eighteen (18) months without a subsequent change in lipid lowering therapy.
- Willing and able to give informed consent before initiation of any study related procedures and willing to comply with all required study procedures.
- On statin therapy, or have documented statin intolerance, as determined by the treating clinician. Participants for whom statin therapy has been recently initiated must be on stable therapy for at least 4 weeks and subsequent LDL-C must be above the threshold.
Key exclusion criteria (10 listed)
- Planned use of other investigational products or devices during the course of the study.
- Treatment with monoclonal antibodies directed towards PCSK9 within 90 days or with inclisiran within 180 days of pre-screening.
- History of hypersensitivity to the study treatment or its excipients or to other siRNA drugs.
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception during dosing of study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InclisiranAlso: LeqvioInclisiran sodium 300 mg/1.5 ml (equivalent to 284 mg inclisiran liquid) in prefilled syringe (PFS). | Drug | Inclisiran |
Primary outcome
Achievement of LDL-C targets
Time frame: Day 360
Achieving LDL-C targets (LDL-C < 70 mg/dL for ASCVD participants or LDL-C < 100 for ASCVD risk equivalent participants) (yes/no)
4 secondary outcomes
Achievement of LDL-C targets by subgroup
Time frame: Day 360
Change in LDL-C from baseline by population
Time frame: Day 360
Achievement of LDL-C targets by population
Time frame: Day 360
Safety and tolerability of inclisiran
Time frame: Through study completion, up to approximately 630 days
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 29 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. This study is not recruiting at the moment.
Neha Pagidipati, MD principal investigator
Duke Clinical Research Institute
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inclisiran in people with Atherosclerotic Cardiovascular Disease, run by Duke University at 23 sites 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 6 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 29 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 23 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Achievement of LDL-C targets (time frame: Day 360). 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 29 Jul 2026.