Back to resultsNP202 for Treatment of Post -STEMI Left Ventricular Systolic Dysfunction
Primary Purpose
ST Elevation Myocardial Infarction
Status
Unknown status
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
NP202
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for ST Elevation Myocardial Infarction
Eligibility 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.
Sites / Locations
- John Hunter HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
NP202
Placebo
Arm Description
1000mg oral NP202 daily for 90 days
Oral placebo daily for 90 days
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Efficacy as measured by Change from baseline in LV ejection fraction (LVEF)
Change from baseline in LVEF as assessed by MRI at 3 months.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02557217
Brief Title
NP202 for Treatment of Post -STEMI Left Ventricular Systolic Dysfunction
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 Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
February 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Armaron Bio Pty Ltd
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NP202
Arm Type
Experimental
Arm Description
1000mg oral NP202 daily for 90 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral placebo daily for 90 days
Intervention Type
Drug
Intervention Name(s)
NP202
Intervention Description
Active
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Microcellulose
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Efficacy as measured by Change from baseline in left ventricular end systolic volume index (LVESVi)
Description
Change from baseline in left ventricular end systolic volume index (LVESVi) as assessed by MRI at 3 months
Time Frame
From baseline to 3 months post MI
Secondary Outcome Measure Information:
Title
Efficacy as measured by Change from baseline in LV end diastolic volume index (LVEDVi)
Description
Change from baseline in LV end diastolic volume index (LVEDVi) as assessed by MRI at 3 months.
Time Frame
From baseline to 3 months post MI
Title
Efficacy as measured by Change from baseline in LV ejection fraction (LVEF)
Description
Change from baseline in LVEF as assessed by MRI at 3 months.
Time Frame
From baseline to 3 months post MI
Title
Efficacy as measured by Change from baseline in LV diastolic function
Description
Changes from baseline in LV diastolic function based on LV peak filling rate as assessed by MRI at 3 months.
Time Frame
From baseline to 3 months post MI
Title
Efficacy as measured by Change from baseline in relative infarct size
Description
Change from baseline in relative infarct size as a percent of LV mass as assessed by late contrast enhancement MRI at 3 months.
Time Frame
From baseline to 3 months post MI
Other Pre-specified Outcome Measures:
Title
Safety as assessed by occurrence of adverse events (AE)
Description
All AE occurring during the study will be recorded
Time Frame
From baseline to end of study (4 months)
Title
Safety as assessed by changes in laboratory results
Description
Biochemistry, haematology, prostate specific antigen (PSA), urinalysis
Time Frame
At Baseline, Week 2, and Months 1, 2, 3 and 4
Title
Safety as assessed by changes in physical examination
Description
Changes in physical examination finding including vital signs (heart rate, blood pressure, respiratory rate, temperature)
Time Frame
At Baseline, Week 2, and Months 1, 2, 3 and 4
Title
Safety as assessed by changes in 12-lead electrocardiograms (ECGs).
Description
Changes in ECG intervals
Time Frame
At Baseline, Week 2, and Months 1, 2, 3 and 4
Title
Trough levels of NP202 in plasma
Description
Concentrations of NP202 in plasma in a subset of 30 subjects.
Time Frame
At Baseline, Week 2 and at Months 1, 2 and 3
Title
Efficacy as assessed by laboratory biomarkers
Description
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)
Time Frame
At Baseline and Months 1, 2 and 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Grant McLachlan
Phone
+61 3 9652 2117
Email
grant.mclachlan@armaronbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grant McLachlan
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Director
Facility Information:
Facility Name
John Hunter Hospital
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
33851966
Citation
Boyle AJ, Schultz C, Selvanayagam JB, Moir S, Kovacs R, Dib N, Zlotnick D, Al-Omary M, Sugito S, Selvarajah A, Collins N, McLachlan G. Calcium/Calmodulin-Dependent Protein Kinase II Delta Inhibition and Ventricular Remodeling After Myocardial Infarction: A Randomized Clinical Trial. JAMA Cardiol. 2021 Jul 1;6(7):762-768. doi: 10.1001/jamacardio.2021.0676.
Results Reference
derived
Learn more about this trial
NP202 for Treatment of Post -STEMI Left Ventricular Systolic Dysfunction
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