Amgen announced plans to conduct VESALIUS-CV, a multinational clinical outcomes study for Repatha which will involve at least 13,000 patients worldwide at high risk of experiencing a first cardiovascular event, despite optimized treatment with lipid-lowering therapy. The study will be the first to investigate long-term outcomes in this population with Repatha for a minimum of four years. enrollment for VESALIUS-CV is due to begin in the second quarter of 2019. The multicenter, double-blind, randomized, placebo-controlled, parallel-group outcomes study will include high-risk patients who have not yet had a heart attack or stroke, but have coronary, cerebrovascular or peripheral arterial disease, who may have had interventions, such as a coronary arterial bypass graft or stents, or who may have diabetes with indicators of increased CVD risk. “High cholesterol is the most important risk factor in coronary heart and vascular disease, but we know that recommended levels of LDL-C or ‘bad’ cholesterol are frequently not reached in very high-risk patients,” said Robert Giugliano, M.D., principal investigator and a senior investigator at the TIMI Study Group at Brigham and Women’s Hospital and Harvard Medical School. “The VESALIUS-CV study will explore the impact of evolocumab on major cardiovascular events, such as heart attack or stroke, in patients who are already receiving treatment for lipid lowering and cardiovascular disease, but remain at high-risk, allowing us to better understand the benefits of significant LDL-C lowering in multiple patient types.”
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