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NP202 for Treatment of Post -STEMI Left Ventricular Systolic Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02557217
Recruitment Status : Unknown
Verified June 2017 by Armaron Bio Pty Ltd.
Recruitment status was:  Recruiting
First Posted : September 23, 2015
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
Armaron Bio Pty Ltd

Brief 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).

Condition or disease Intervention/treatment Phase
ST Elevation Myocardial Infarction Drug: NP202 Other: Placebo Phase 2

Detailed 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: NP202
1000mg oral NP202 daily for 90 days
Drug: NP202
Active

Placebo Comparator: Placebo
Oral placebo daily for 90 days
Other: Placebo
Placebo
Other Name: Microcellulose




Primary Outcome Measures :
  1. Efficacy as measured by Change from baseline in left ventricular end systolic volume index (LVESVi) [ Time Frame: From baseline to 3 months post MI ]
    Change from baseline in left ventricular end systolic volume index (LVESVi) as assessed by MRI at 3 months


Secondary Outcome Measures :
  1. Efficacy as measured by Change from baseline in LV end diastolic volume index (LVEDVi) [ Time Frame: From baseline to 3 months post MI ]
    Change from baseline in LV end diastolic volume index (LVEDVi) as assessed by MRI at 3 months.

  2. Efficacy as measured by Change from baseline in LV ejection fraction (LVEF) [ Time Frame: From baseline to 3 months post MI ]
    Change from baseline in LVEF as assessed by MRI at 3 months.

  3. Efficacy as measured by Change from baseline in LV diastolic function [ Time Frame: From baseline to 3 months post MI ]
    Changes from baseline in LV diastolic function based on LV peak filling rate as assessed by MRI at 3 months.

  4. Efficacy as measured by Change from baseline in relative infarct size [ Time Frame: From baseline to 3 months post MI ]
    Change from baseline in relative infarct size as a percent of LV mass as assessed by late contrast enhancement MRI at 3 months.


Other Outcome Measures:
  1. Safety as assessed by occurrence of adverse events (AE) [ Time Frame: From baseline to end of study (4 months) ]
    All AE occurring during the study will be recorded

  2. Safety as assessed by changes in laboratory results [ Time Frame: At Baseline, Week 2, and Months 1, 2, 3 and 4 ]
    Biochemistry, haematology, prostate specific antigen (PSA), urinalysis

  3. Safety as assessed by changes in physical examination [ Time Frame: At Baseline, Week 2, and Months 1, 2, 3 and 4 ]
    Changes in physical examination finding including vital signs (heart rate, blood pressure, respiratory rate, temperature)

  4. Safety as assessed by changes in 12-lead electrocardiograms (ECGs). [ Time Frame: At Baseline, Week 2, and Months 1, 2, 3 and 4 ]
    Changes in ECG intervals

  5. Trough levels of NP202 in plasma [ Time Frame: At Baseline, Week 2 and at Months 1, 2 and 3 ]
    Concentrations of NP202 in plasma in a subset of 30 subjects.

  6. Efficacy as assessed by laboratory biomarkers [ Time Frame: At Baseline and Months 1, 2 and 3 ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557217


Contacts
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Contact: Grant McLachlan +61 3 9652 2117 grant.mclachlan@armaronbio.com

Locations
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Australia, New South Wales
John Hunter Hospital Recruiting
Newcastle, New South Wales, Australia, 2305
Sponsors and Collaborators
Armaron Bio Pty Ltd
Investigators
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Study Director: Grant McLachlan Sponsor GmbH
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Responsible Party: Armaron Bio Pty Ltd
ClinicalTrials.gov Identifier: NCT02557217    
Other Study ID Numbers: NP202-002
ACTRN12615000609550 ( Registry Identifier: Australian New Zealand Clinical Trials Registry )
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases