V-INCLUSION Clinical Trial Will Soon Open for Enrollment

The trial will assess the impact of a cholesterol management drug on patients from demographically diverse populations.

A new clinical trial led by the Duke Clinical Research Institute (DCRI) aims to understand whether a cholesterol-lowering medication can help control LDL-C (i.e. “bad cholesterol”) in real-world settings, specifically in diverse populations. Historically, cardiovascular clinical trials have not reflected the full diversity of the U.S. population, nor the people most affected by the conditions being studied.

VictORION-INCLUSION: INClisiran as a soLUtion to improve LDL-C management and cloSe care gaps in an Inclusive ASCVD and ASCVD risk equivalent populatiON” (V-INCLUSION) will soon open for enrollment. This clinical trial plans to enroll 1,440 racially, ethnically, and geographically diverse participants with established atherosclerotic cardiovascular disease (ASCVD) or those at high-risk of ASCVD. The trial will help assess the effects of inclisiran on this patient population.

Inclisiran is an injectable prescription medicine used along with diet and other cholesterol lowering medicines in adults with high blood cholesterol levels called primary hyperlipidemia (including a type of high cholesterol called heterozygous familial hypercholesterolemia [HeFH]) to reduce low density lipoprotein (LDL­C) or “bad” cholesterol.

V-INCLUSION will leverage the resources of PCORnet® (the National Patient-Centered Clinical Research Network) and use electronic health records to identify potential participants. The design of V-INCLUSION ensures that everyone participating will have access to inclisiran either in the first year or the second year of the study.

Neha Pagidipati, M.D.

“People can experience different barriers to achieving health that prevent them from getting the right treatments at the right time for controlling cholesterol and decreasing the risk for heart disease,” said Dr. Neha Pagidipati, MD, MPH, an Associate Professor of Medicine and cardiovascular disease prevention specialist and Principal Investigator of V-INCLUSION. “Our hope is that V-INCLUSION will help generate important new evidence on how to keep people healthy.”

V-INCLUSION is sponsored by Novartis, operated through Duke Clinical Research Institute (DCRI), and is a PCORnet® Study.

V-INCLUSION ClinicalTrials.gov identifier: NCT06249165

About the Duke Clinical Research Institute

The DCRI, part of the Duke University School of Medicine, is the largest academic clinical research organization in the world. Our mission is to develop, share, and implement knowledge that improves global health through innovative clinical research. The institute conducts multinational clinical trials, manages major national patient registries, and performs landmark outcomes research. The DCRI is a pioneer in cardiovascular and pediatric clinical research, and conducts groundbreaking clinical research across multiple other therapeutic areas, including infectious disease, neuroscience, respiratory medicine, and nephrology.

About PCORnet

PCORnet®, the National Patient-Centered Clinical Research Network, is intended to improve the nation’s capacity to conduct health research, particularly comparative effectiveness research (CER), efficiently by creating a large, highly representative network for conducting clinical outcomes research. PCORnet® has been developed with funding from the Patient-Centered Outcomes Research Institute (PCORI).