NP202 for Treatment of Post -STEMI Left Ventricular Systolic Dysfunction

Armaron Bio

Status and phase: Unknown; Phase 2

Conditions: ST Elevation Myocardial Infarction

Treatments: Drug: NP202; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02557217

ACTRN12615000609550 (Registry Identifier)

NP202-002

Details and patient eligibility

About

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).

Full 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

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

NP202

Experimental group

Description:

1000mg oral NP202 daily for 90 days

Treatment:

Drug: NP202

Placebo

Placebo Comparator group

Description:

Oral placebo daily for 90 days

Treatment:

Other: Placebo