Further Cardiovascular OUtcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk
Design and Objective
A double-blind, randomised, placebo-controlled, multicenter study assessing the impact of additional LDL-cholesterol reduction on major cardiovascular events when a PCSK9 inhibitor is used in combination with optimal statin therapy in patients with clinically evident cardiovascular disease. Patients auto-inject study drug or placebo every 2 or 4 weeks, for up to 5 years. The study will recruit 27,500 subjects globally.
Key inclusion criteria
Male or female aged 40 to 85 years History of clinically evident cardiovascular disease (myocardial infarction, ischemic stroke, peripheral vascular disease) at high risk for a recurrent event Fasting LDL-C ≥ 70 mg/dL (1.8 mmol/L) or non-HDL-C ≥ 100 mg/dL (2.6 mmol/L) Fasting triglycerides ≤ 400 mg/dl (4.5 mmol/L)