Last updated on August 2018

Evaluation of Coronary Artery Plaque Volume Progression/Regression and Safety of Alirocumab in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia

Brief description of study

Primary Objective: To compare the efficacy of alirocumab with standard of care on coronary atheroma progression in patients who have experienced an acute coronary syndrome (ACS) event and are treated with atorvastatin or rosuvastatin. Secondary Objectives: - To compare the efficacy of alirocumab with standard of care on absolute change in percent atheroma volume (PAV) and normalized total atheroma volume (TAV). - To evaluate the efficacy of alirocumab on low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo-B), triglycerides, non-high-density lipoprotein cholesterol (non-HDL-C) and Lipoprotein(a)(Lp[a]). - To evaluate the safety of alirocumab including the occurrence of cardiovascular events (coronary heart disease [CHD] death, non-fatal myocardial infarction [MI], fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization).

Detailed Study Description

The duration of study per patient is 9 months.

Clinical Study Identifier: NCT02984982

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Investigational Site Number 392035
Sapporo-shi, Japan