A new clinical trial aims to understand whether the early addition of the LDL-cholesterol-lowering medication inclisiran can help reduce cardiac and limb events, such as heart attack, stroke, or amputation, in people who have recently undergone a successful revascularization procedure. Revascularization procedures, also known as stents, help improve a person’s blood flow in the arteries of the cardiovascular system, such as in the heart or legs. The trial, called VictORION-INTERVENTION: Evaluation of inclisiran versus placebo for the prevention of major adverse cardiovascular and limb events in patients undergoing percutaneous coronary intervention or peripheral endovascular intervention (V-INTERVENTION), has enrolled its first participant.
“Participants in V-INTERVENTON have the opportunity to help themselves, and others, get better control over their LDL-cholesterol as we investigate the potential of inclisiran to reduce their risk of future cardiac or vascular problems following revascularization,” said Schuyler Jones, MD, a faculty member in the Duke Clinical Research Institute (DCRI), an interventional cardiologist at Duke Health and co-principal investigator of V-INTERVENTION.
Inclisiran is a prescription medicine indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). It is a subcutaneous injection given by a health care provider every six months after an initial dose and a second dose three months later. Reducing LDL-cholesterol has been proven, with some therapies and medications, to mitigate the risk of future cardiac events—a major concern for people undergoing revascularization procedures—with improvements being proportional to the reduction in LDL cholesterol levels. However, many patients remain above guideline-directed LDL cholesterol goals and are also often not taking maximum doses of recommended cholesterol-lowering therapies after revascularization procedures.
“As interventional cardiologists, we know that our job does not end with the procedure. This landmark trial offers a unique opportunity to optimize patient care and evaluate the long-term benefits of LDL cholesterol reduction with inclisiran in those undergoing revascularization. It’s time we close the gap between procedural success and sustained cardiovascular health,” said Roxana Mehran, MD, a member of the V-INTERVENTION Executive Committee and director of interventional cardiovascular research and clinical trials at the Icahn School of Medicine at Mount Sinai. “Too many patients leave the catheterization lab without achieving optimal cholesterol control in the months that follow. V-INTERVENTION will help determine whether a twice-yearly injectable like inclisiran can simplify care and reduce the risk of adverse events in this high-risk population.”
Researchers for V-INTERVENTION plan to enroll about 6,000 participants across 250 United States sites over the next 18 months. When the follow-up period ends, researchers will compare treatment with inclisiran versus placebo for lowering the number of major adverse outcomes following a revascularization procedure in the heart or legs.
“We’re honored to collaborate with this distinguished group of cardiovascular leaders and are hopeful the findings will lead to improved care for this vulnerable patient population,” said Cesar Cerezo, vice president, medical head, cardiovascular metabolic/nephrology at Novartis Pharmaceuticals Corp. “We aim to demonstrate that earlier and aggressive LDL cholesterol lowering with inclisiran can lead to improved cardiovascular outcomes post-revascularization. Conducting a large pragmatic study like this is much needed and allows us to better reflect real-world clinical practice.”
“I am personally excited to be a part of this collaboration that aims to improve the cardiovascular health of people in the United States by engaging and activating the patients and clinicians at the time of an interventional procedure to improve the underlying disease as much as possible,” said Manesh Patel, MD, co-chair of the study, member at the DCRI, and chief of cardiology at Duke University Health System. “Hopefully, if successful, we can develop a new paradigm for the care of people undergoing procedures.”
V-INTERVENTION ClinicalTrials.gov identifier: 06909565
About the Duke Clinical Research Institute
The Duke Clinical Research Institute (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 CPC Clinical Research
Founded in 1989 by the University of Colorado, The Colorado Prevention Center, doing business as CPC Clinical Research (CPC), is a non-profit academic research organization recognized for its scientific leadership and operational excellence in clinical trial execution. With over 30 years of experience, CPC specializes in research to improve care for patients with a broad range of conditions, including vascular disease, cardiometabolic diseases, heart failure, and kidney disease. Capabilities include full-service clinical trial support across phases, pragmatic trials, effectiveness research, and real-world evidence.
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