Clinical Investigation

The Roanoke Heart Institute emphasizes the application of advanced pharmacological means of prevention as well as treatment of cardiovascular diseases. We always use proven therapies first at the RHI. However, you may also have access to new tests or treatments under clinical investigation in studies either sponsored through the National Institutes of Health or by reputable companies in the pharmaceutical industry, as approved by the Food and Drug Administration.

New tests and treatments are only used with your consent. Our actively enrolling studies are listed below for your information. Study medications are provided to the patients free of charge. Please note that there are detailed inclusion and exclusion criteria for each study, and these will be examined if you otherwise qualify for participation.

VICTORION-1-PREVENT (Novartis) “A randomized, double-blind, placebo-controlled, multicenter study to evaluate the effect of inclisiran on preventing major adverse cardiovascular events in high-risk primary prevention patients.”
-Seeking patients with elevated “bad cholesterol” over 70 mg/dL, despite statin use, and risk factors for coronary heart disease, like diabetes.

VICTORION-2-PREVENT (Novartis) “A randomized, double-blind, placebo-controlled, multicenter trial, assessing the impact of inclisiran on major adverse cardiovascular events in participants with established cardiovascular disease.”
-Seeking patients with elevated “bad cholesterol” over 70 mg/dL, despite statin use, and a history of heart attack, coronary stents, or stroke.

HERMES (Novo Nordisk) “Effects of ziltivekimab versus placebo on morbidity and mortality in patients with heart failure with mildly reduced or preserved ejection fraction and systemic inflammation.”
-Seeking patients with heart failure featuring mildly reduced or preserved echocardiographic ejection fraction that have lab evidence of disease, including elevated “BNP” and elevated “CRP.”

LILAC (Anthos Therapeutics) “A Phase 3, multicenter, randomized, double-blind, placebo controlled, parallel-group study to evaluate the efficacy and safety of abelacimab in high-risk patients with atrial fibrillation who have been deemed unsuitable for oral anticoagulation.”
-Seeking patients with atrial fibrillation or flutter that cannot take standard oral anticoagulation agents, oftentimes due to a history of bleeding.

LIBREXIA-AF (Janssen) “A phase 3, randomized, double-blind, double-dummy, parallel group, active controlled study to evaluate the efficacy and safety of milvexian, an oral factor XIa inhibitor, versus apixaban in participants with atrial fibrillation.”
-Seeking patients on warfarin, apixaban or rivaroxaban that are looking for an alternative anticoagulant.