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VictORION-INCLUSION: Evaluating Inclisiran for Cholesterol Managment in Heart Disease

Study acronym: V-INCLUSION
StatusActive, Not Recruiting
PhasePhase 4
Started2024-12-16
View on ClinicalTrials.gov ↗

Amendment history

2026-07-28
Study Status v15
Primary completion pushed: 2026-12 → 2026-12-31
Completion date2027-02→2027-02-28
2025-11-04
Study Status, Study Description, Outcome Measures, Eligibility v14
Primary completion date2026-09→2026-12
Completion date2026-12→2027-02
Eligibility criteria+397 characters
[...] tatin 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 cardiovasc [...] the HRSA definition for determining rural grant eligibility using the Federal Office of Rural Health Policy (FORHP) 2010 County and Census Tract file. Exclusion Criteria: Cannot meet any criteria below. Planne [...] hods (i.e. via ablation etc.) at the time of pre-screening. Controlled arrhythmia is not an exclusion. Uncon [...] [...]
Secondary endpoints5 to 4 entries
NumberAchievement of participants achieving LDL-C targets by subgroupssubgroup Absolute change from baseline in LDL-C Percent change from baseline in LDL-C Average absolute change from baselineChange in LDL-C at each post-baseline visit Average percent change from baseline inby population Achievement of LDL-C attargets eachby post-baselinepopulation Safety visitand tolerability of inclisiran
Study description+713 characters
[...] ith 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 co [...] The study population will consist of underrepresented and historically understudied male and female participants (at leasttargeting 50% female, 70% underrepresented [Black/African American, H [...] to inclisiran + usual care or usual care in a 1: [...]
2025-06-10
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v13
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 1440→confirmed 130
Study sites39→23
2025-06-02
Study Status, Contacts/Locations v12
Primary completion date2027-07→2026-09
Completion date2028-07→2026-12
Study sitesdetails revised at 17 of 39 sites
2025-05-16
Study Status, Contacts/Locations v11
Primary completion date2027-01→2027-07
Completion date2028-01→2028-07
Study sites38→39
Show 10 earlier versions
2025-04-22
Study Identification, Study Status, Contacts/Locations v10
Study sites30→38
2025-03-18
Study Status, Contacts/Locations v9
Primary completion date2026-08→2027-01
Completion date2027-08→2028-01
Study sitesdetails revised at 4 of 30 sites
2025-02-20
Study Status, Contacts/Locations v8
Study sitesdetails revised at 4 of 30 sites
2025-02-03
Study Status, Contacts/Locations v7
Study sitesdetails revised at 1 of 30 sites
2025-01-23
Study Status, Contacts/Locations v6
Primary completion date2026-07→2026-08
Completion date2027-07→2027-08
Start dateestimated 2024-11→confirmed 2024-12-16
Study sites3→30
2024-11-18
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v5
Trial statusNot Yet Recruiting→Recruiting
Study sites0→3
2024-10-16
Study Status v4
Primary completion date2026-06→2026-07
Start date2024-09→2024-11
2024-08-15
Study Identification, Study Status, Outcome Measures v3
Primary completion date2026-06-08→2026-06
Completion date2027-07-03→2027-07
Start date2024-08→2024-09
2024-08-02
Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v2
Completion date2026-11-03→2027-07-03
Start date2024-07-24→2024-08
Lead sponsorNovartis Pharmaceuticals→Duke University
Eligibility criteria-2,477 characters
Inclusion Criteria: Participants eligible for inclusion in this study mustMust meet all ofcriteria the following criteria:below. Males and females ≥>= 18 years of age. Patients must haveHave clinical ASCVD or ASCVD risk equivalent diagnosis captured in EHR. ASCVD Risk Equivalent defined as: History of Type 2 Diabetes Mellitus 10 year ASCVD risk score ≥ 20% (based on ACC/AHA Pooled Cohort Equation ASCVD Risk Estimator (https://tools.acc.org/ldl/ascvd_risk_estimator/index.html#!/calulate/estimator/ ) History of heterozygous familial hyperlipidemia (HeF [...] Serum LDL-C ≥ 70 mg/dL for participants wit [...] [...]
Secondary endpoints6 to 5 entries
Number of participants achieving LDL-C targets by underrepresented and historically understudied populations Number of ASCVD participants and ASCVD risk equivalent participants achieving LDL-C targetssubgroups
Primary endpoints1 entry, revised
NumberAchievement of participants achieving LDL-C targets
Study description+40 characters
[...] ve treatment threshold despite treatment with statin therapy (or with documented statin intolerance). The study population will consist of underrepresented and [...]
Collaborators+24 characters
Novartis Pharmaceuticals
Study title-152 characters
VictORION-INCLUSION: is a Multicenter, Randomized, Open Label, Study ofEvaluating Inclisiran +for UsualCholesterol Care vs Usual Care AloneManagment in anHeart Inclusive and Underrepresented Population at High Risk for or Diagnosed With ASCVD Within a Pragmatic EHR Framework.Disease
2024-05-08
Study Status v1
Start date2024-03-15→2024-07-24
2024-01-31
Original filing
Duke University
455 trials monitored
See 53 trials at risk
Heart Disease
2,117 trials monitored
See 101 trials at risk
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.
Trial Details
NCT Number NCT06249165
Lead Sponsor Duke University
Collaborators: Novartis Pharmaceuticals
Conditions Atherosclerotic Cardiovascular Disease
Enrollment 130 participants
Start Date 2024-12-16
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-07-29