A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of CSL112 in Subjects with Acute Coronary Syndrome - AEGIS-II / ApoA-I Event reducinG in Ischemic Syndromes II

CSL Behring LLC0 个研究点目标入组 17,400 人开始时间: 2018年5月25日最近更新: 2024年1月8日

研究概览

暂无简介。

•1. Male or female least 18 years of age
•2. Evidence of myocardial necrosis, consistent with type (spontaneous) MI
•3. No suspicion of acute kidney injury
•4. Evidence of multivessel coronary artery disease and at least 1 of the following established risk factors:age = 65 years, prior history of MI, diabetes mellitus, or peripheral artery disease
•5. Presence of established cardiovascular risk factor(s):
•a. Diabetes mellitus on pharmacotherapy OR
•b. 2 or more of the following: age = 65 years, prior history of MI, peripheral arterial disease
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 6960
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10440

•1. Ongoing hemodynamic instability
•2. Evidence of hepatobiliary disease
•3. Evidence of severe chronic kidney disease
•4. Plan to undergo scheduled coronary artery bypass graft surgery as treatment for the index MI
•5. Known history of allergies, hypersensitivity, or deficiencies to soy bean, peanut or albumin

发起方