A Phase II Randomised, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Oral NP202 in Adults who have Left Ventricular Systolic Dysfunction following Myocardial Infarction.

Armaron Bio Pty Ltd0 个研究点目标入组 147 人开始时间: 2015年6月11日最近更新: 2021年8月10日

研究概览

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•Participants who:
•- Have had a confirmed ST elevation myocardial infarction (STEMI) in the previous 5 days, which met all of the following criteria;
•* less than or equal to 0.2 mV ST elevation in 2 or more V1 – V6 leads with presentation in a maximum of 12 hours of onset of symptoms
•* Troponin levels greater than 10 x upper limit of normal at the site’s local laboratory.
•* Successfully revascularised with percutaneous coronary intervention (PCI)
•- Have left ventricular dysfunction post STEMI as evidenced by left ventricular ejection fraction less than or equal to 40% confirmed by echocardiogram at screening.
•- Are receiving guideline-directed medical therapy for acute MI and post-MI left ventricular dysfunction according to national cardiology society/heart association STEMI guidelines.

•Participants with:
•- Known cardiomyopathy or heart failure prior to MI.
•- Cardiogenic shock and/or systolic blood pressure less than 85mmHg at Screening.
•- Clinical history of ejection fraction less than or equal to 40% prior to this MI, or multiple prior MIs.
•- Daily use of non-steroidal anti-inflammatory drugs (NSAIDs) and/or cyclooxygenase-2 (COX-2) inhibitors in the past month.
•- Presence of device/hardware incompatible with MR imaging
•- Estimated glomerular filtration rate (eGFR) less than 30ml/min
•- Liver function tests 3 x upper limit of normal due to non cardiac disease
•- Have received any investigational research agent within 30 days or 5 half-lives (whichever is longer) prior to the first dose of Investigational Product

发起方

Armaron Bio Pty Ltd