Last updated on November 2017

ODYSSEY OUTCOME STUDY - A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of SAR236553/REGN727 on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome


Brief description of study

ODYSSEY OUTCOME STUDY - A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of SAR236553/REGN727 on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome

Detailed Study Description

This study is looking at investigational drug, SAR236553, in patients who experienced a coronary event. One of the main risk factors for developing coronary heart disease is high levels of cholesterol in the blood, in particular high levels of a particular type of cholesterol called LDL-cholesterol (bad cholesterol). SAR236553 is an antibody (a type of protein) that binds a substance called PCSK9. The substance PCSK9 is secreted from the liver into the blood and increases LDL-cholesterol levels in the blood. Therefore, blocking PCSK9 through the use of the study drug can potentially decrease the blood LDL-cholesterol (bad cholesterol) levels of patients with high blood cholesterol.

Large studies conducted with statins have shown that lowering the blood cholesterol level, and more particularly the LDL-cholesterol, reduces the risk of cardiovascular events. The purpose of this study is to determine whether the study drug might prevent future cardiovascular events (such as, heart attacks or strokes) in qualifying patients. The study will compare the study drug versus a placebo injection on the occurrence of future cardiovascular events such as heart attack and stroke, when given in addition to the standard of care for lowering cholesterol.

Clinical Study Identifier: TX81257

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Cheryl Langer, RN

Holy Cross Jim Moran Heart and Vascular Research Institute
Fort Lauderdale, FL USA
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