NP202 for Treatment of Post -STEMI Left Ventricular Systolic Dysfunction

ST Elevation Myocardial Infarction Clinical Trial

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

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
• 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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• Ventricular Dysfunction, Left

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