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 Ltd
147 participants
Nov 20, 2015
Interventional
Conditions
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). 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, so new drugs are needed. 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. It is hoped that NP202 will help to reduce the damage to the heart that is caused by a MI in humans.
Eligibility
Inclusion Criteria7
- 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.
Exclusion Criteria9
- 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
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Interventions
NP202 oral capsules, 1000mg, once daily for 90 days. 50% of subjects will receive NP202. Compliance will be assessed by capsule count.
Locations(2)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12615000609550