VictORION-INCLUSION is a Multicenter, Randomized, Open Label, Study of Inclisiran + Usual Care vs Usual Care Alone in an Inclusive and Underrepresented Population at High Risk for or Diagnosed With ASCVD Within a Pragmatic EHR Framework. — V-INCLUSION  

Atherosclerotic Cardiovascular Disease Clinical Trial

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

Status Not yet recruiting

Clinical Trial Summary

The purpose of this study is to measure the effectiveness of inclisiran compared to usual care in an inclusive study population (women, racial/ethnic minorities, and rural dwelling participants) which has historically been more likely to receive suboptimal lipid management, as a potential solution to improve care gaps. The study duration will be up to 360 days for participants randomized to the inclisiran with usual care arm and up to 720 days for participants initially randomized to the usual care arm.

Clinical Trial 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.

The study population will consist of underrepresented and historically understudied male and female participants (at least 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 approximately 30 US healthcare systems. ;

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Cardiovascular Diseases

• NCT number: NCT06249165
• Study type: Interventional
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email@novartis.com
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 24, 2024
• Completion date: November 3, 2026