NP202 for Treatment of Post -STEMI Left Ventricular Systolic Dysfunction
- Registration Number
- NCT02557217
- Lead Sponsor
- Armaron Bio Pty Ltd
- Brief Summary
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).
- Detailed Description
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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
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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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NP202 NP202 1000mg oral NP202 daily for 90 days Placebo Placebo Oral placebo daily for 90 days
- Primary Outcome Measures
Name Time Method Efficacy as measured by Change from baseline in left ventricular end systolic volume index (LVESVi) 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
- Secondary Outcome Measures
Name Time Method Efficacy as measured by Change from baseline in LV diastolic function From baseline to 3 months post MI Changes from baseline in LV diastolic function based on LV peak filling rate as assessed by MRI at 3 months.
Efficacy as measured by Change from baseline in LV ejection fraction (LVEF) From baseline to 3 months post MI Change from baseline in LVEF as assessed by MRI at 3 months.
Efficacy as measured by Change from baseline in relative infarct size From baseline to 3 months post MI Change from baseline in relative infarct size as a percent of LV mass as assessed by late contrast enhancement MRI at 3 months.
Efficacy as measured by Change from baseline in LV end diastolic volume index (LVEDVi) From baseline to 3 months post MI Change from baseline in LV end diastolic volume index (LVEDVi) as assessed by MRI at 3 months.
Trial Locations
- Locations (1)
John Hunter Hospital
🇦🇺Newcastle, New South Wales, Australia