NP202 for Treatment of Post -STEMI Left Ventricular Systolic Dysfunction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-02-28

Brief Summary

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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).

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Detailed Description

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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

Conditions

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ST Elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NP202

1000mg oral NP202 daily for 90 days

Group Type EXPERIMENTAL

NP202

Intervention Type DRUG

Active

Placebo

Oral placebo daily for 90 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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NP202

Active

Intervention Type DRUG

Placebo

Intervention Type OTHER

Other Intervention Names

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Microcellulose

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No