NCT06249165

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

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Atherosclerotic Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	Inclisiran	Inclisiran sodium 300 mg/1.5 ml (equivalent to 284 mg inclisiran liquid) in prefilled syringe (PFS).

Timeline

• Start date: 2024-12-16
• Primary completion: 2026-12-01
• Completion: 2027-02-01
• First posted: 2024-02-08
• Last updated: 2025-11-06

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study