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
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Efficacy as measured by Change from baseline in left ventricular end systolic volume index (LVESVi)
研究概览
简要总结
NP202 is an experimental drug being developed by Armaron Bio Pty Ltd for potential use as a treatment for people after they have had a heart attack (MI).
详细描述
After someone has a MI, their heart 'remodels', which means that it changes in size and shape. This damage can lead to it being weaker and less efficient, and ultimately to major heart problems. There are some drugs currently available which help prevent remodelling and are used for treatment post-MI. However, there is still a high rate of remodelling and major heart problems in people post-MI. NP202 works in a different way to the drugs that are currently approved, and has been shown in animal studies to prevent post-MI remodelling.
This study will assess NP202 versus placebo on remodelling over a 3 month treatment period, with 1 month follow up
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have had a confirmed ST elevation myocardial infarction (STEMI) in the previous 5 days, which met all of the following criteria;
- •≥ 0.2mV ST elevation in 2 or more V1 - V6 leads with presentation in a maximum of 12 hours of onset of symptoms
- •Troponin levels >10 x upper limit of normal (ULN) at the site's local laboratory.
- •Successful revascularisation by Percutaneous Coronary Intervention (PCI)
- •Have left ventricular dysfunction post STEMI as evidenced by left ventricular ejection fraction (LVEF) ≤40% confirmed by echocardiogram at screening.
- •Are receiving guideline-directed medical therapy for acute MI and post-MI left ventricular (LV) dysfunction according to national cardiology society/heart association STEMI guidelines.
排除标准
- •Known cardiomyopathy or heart failure prior to MI.
- •Cardiogenic shock and/or systolic blood pressure <85mmHg at Screening.
- •Clinical history of ejection fraction ≤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 MRI
- •Estimated glomerular filtration rate (eGFR) <30ml/min
- •Liver function tests 3 x ULN 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.
研究组 & 干预措施
NP202
1000mg oral NP202 daily for 90 days
干预措施: NP202 (Drug)
Placebo
Oral placebo daily for 90 days
干预措施: Placebo (Other)
结局指标
主要结局
Efficacy as measured by Change from baseline in left ventricular end systolic volume index (LVESVi)
时间窗: From baseline to 3 months post MI
Change from baseline in left ventricular end systolic volume index (LVESVi) as assessed by MRI at 3 months
次要结局
- Efficacy as measured by Change from baseline in LV diastolic function(From baseline to 3 months post MI)
- Efficacy as measured by Change from baseline in LV ejection fraction (LVEF)(From baseline to 3 months post MI)
- Efficacy as measured by Change from baseline in relative infarct size(From baseline to 3 months post MI)
- Efficacy as measured by Change from baseline in LV end diastolic volume index (LVEDVi)(From baseline to 3 months post MI)