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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02557217
Other study ID # NP202-002
Secondary ID ACTRN12615000609
Status Recruiting
Phase Phase 2
First received September 7, 2015
Last updated June 26, 2017
Start date October 2015
Est. completion date February 2018

Study information

Verified date June 2017
Source Armaron Bio Pty Ltd
Contact Grant McLachlan
Phone +61 3 9652 2117
Email grant.mclachlan@armaronbio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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 information / eligibility

Status Recruiting
Enrollment 120
Est. completion date February 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
NP202
Active
Other:
Placebo
Placebo

Locations

Country Name City State
Australia John Hunter Hospital Newcastle New South Wales

Sponsors (1)

Lead Sponsor Collaborator
Armaron Bio Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Other Safety as assessed by occurrence of adverse events (AE) All AE occurring during the study will be recorded From baseline to end of study (4 months)
Other Safety as assessed by changes in laboratory results Biochemistry, haematology, prostate specific antigen (PSA), urinalysis At Baseline, Week 2, and Months 1, 2, 3 and 4
Other Safety as assessed by changes in physical examination Changes in physical examination finding including vital signs (heart rate, blood pressure, respiratory rate, temperature) At Baseline, Week 2, and Months 1, 2, 3 and 4
Other Safety as assessed by changes in 12-lead electrocardiograms (ECGs). Changes in ECG intervals At Baseline, Week 2, and Months 1, 2, 3 and 4
Other Trough levels of NP202 in plasma Concentrations of NP202 in plasma in a subset of 30 subjects. At Baseline, Week 2 and at Months 1, 2 and 3
Other Efficacy as assessed by laboratory biomarkers Absolute values and changes from baseline in serum biomarker levels (Troponin I, Troponin T, high sensitivity C reactive protein (hs-CRP) and N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) At Baseline and Months 1, 2 and 3
Primary Efficacy as measured by Change from baseline in left ventricular end systolic volume index (LVESVi) Change from baseline in left ventricular end systolic volume index (LVESVi) as assessed by MRI at 3 months From baseline to 3 months post MI
Secondary Efficacy as measured by Change from baseline in LV end diastolic volume index (LVEDVi) Change from baseline in LV end diastolic volume index (LVEDVi) as assessed by MRI at 3 months. From baseline to 3 months post MI
Secondary Efficacy as measured by Change from baseline in LV ejection fraction (LVEF) Change from baseline in LVEF as assessed by MRI at 3 months. From baseline to 3 months post MI
Secondary Efficacy as measured by Change from baseline in LV diastolic function Changes from baseline in LV diastolic function based on LV peak filling rate as assessed by MRI at 3 months. From baseline to 3 months post MI
Secondary Efficacy as measured by Change from baseline in relative infarct size Change from baseline in relative infarct size as a percent of LV mass as assessed by late contrast enhancement MRI at 3 months. From baseline to 3 months post MI
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