Sanatorio maternidad dr. carlos jiménez s.c.

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Sanatorio maternidad dr. carlos jiménez s.c. 2021

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Il s’agit d’une étude de phase 3, multicentrique, en double aveugle, randomisée, contrôlée par placebo et en groupes parallèles, visant à évaluer l’efficacité et l’innocuité de CSL112 dans la réduction du risque d’événements CV indésirables majeurs [MACE – décès cardiovasculaire (CV), infarctus du myocarde (MI), et accident vasculaire cérébral] chez des sujets présentant un syndrome coronarien aigu (SCA) diagnostiqué soit par un infarctus du myocarde avec sus-décalage du segment ST (STEMI), soit par un infarctus du myocarde sans sus-décalage du segment ST (NSTEMI), y compris ceux pris en charge par une intervention coronarienne percutanée (ICP) ou sous traitement médical.
Délai jusqu’à la première apparition de l’un des composants du composite MACE (décès d’origine cardiovasculaire, infarctus du myocarde ou accident vasculaire cérébral) MACE [événement(s) cardiovasculaire(s) indésirable(s) majeur(s)] [décès d’origine cardiovasculaire, infarctus du myocarde ou accident vasculaire cérébral] [Cadre temporel : jusqu’à 90 jours].
Nombre de sujets présentant un changement dans les évaluations de laboratoire clinique entre la valeur de base et la pire valeur post-traitement selon les critères de l’intervalle normal (normal, élevé ou faible) [Cadre temporel : ligne de base et 29 jours].
Pourcentage de sujets dont les résultats des analyses de laboratoire clinique sont passés de la valeur initiale à la pire valeur post-traitement selon les critères de l’intervalle normal (normal, élevé ou faible) [Cadre temporel : base de référence et 29 jours].

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