NP202 for Treatment of Post -STEMI Left Ventricular Systolic Dysfunction

• Status: Unknown status
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Armaron Bio Pty Ltd

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.