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Alirocumab SAR236553 · ODYSSEY J-IVUS

Evaluation of Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia

Ensayo de Sanofi en Hypercholesterolemia · Acute Coronary Syndrome (del registro, en inglés).

Más ensayos de: Hipercolesterolemia.

Fase

Fase 4

Estado

Completado

Participantes

206

previstos

Centros

39

Fin del objetivo primario

jul 2018

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en nov 2016.

Qué mide

Percent Change From Baseline in Normalized Total Atheroma Volume (TAV) at Week 36 (del registro, en inglés) (inicio y semana 36)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objective: To compare the efficacy of alirocumab (Praluent®) with standard of care (SoC) on coronary atheroma progression (percent change in normalized total atheroma volume \[TAV\]) after 9 months of treatment in participants who had acute coronary syndrome (ACS) within 4 weeks prior to randomization, with hypercholesterolemia treated with statin. Secondary Objectives: * To compare the efficacy of alirocumab (Praluent®) with SoC on secondary endpoints including absolute change in percent atheroma volume and normalized TAV after 9 months of treatment. * To evaluate the efficacy of alirocumab (Praluent®) on low-density lipoprotein cholesterol (LDL-C), apolipoprotein B, triglycerides, non-high-density lipoprotein cholesterol and lipoprotein (a) after 9 months treatment. * To evaluate the safety of alirocumab (Praluent®) including the occurrence of cardiovascular events (coronary heart disease death, non-fatal myocardial infarction, fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization) throughout the study.

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Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02984982), actualizada en jul 2019.