ST Elevation Myocardial InfarctionPhase 2NCT02557217
NP202 for Treatment of Post -STEMI Left Ventricular Systolic Dysfunction
A Phase 2 study testing NP202 in people with ST Elevation Myocardial Infarction, run by Armaron Bio Pty Ltd at 1 site in Australia.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ST Elevation Myocardial Infarction
- What is being tested?
- NP202
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2015to Feb 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
John Hunter Hospital
Newcastle, New South Wales, 2305
About this study
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
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).
Read the 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
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- NP202, Placebo
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NP202Drug
Active
PlaceboOther
Also called Microcellulose
Placebo
| Study group | Role | What they receive |
|---|---|---|
| NP202 | Experimental | 1000mg oral NP202 daily for 90 days Receives: Drug: NP202 |
| Placebo | Placebo comparator | Oral placebo daily for 90 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From baseline to 3 months post MI
Secondary outcomes (4)
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.
Measured: From baseline to 3 months post MI
Efficacy as measured by Change from baseline in LV ejection fraction (LVEF)
Change from baseline in LVEF as assessed by MRI at 3 months.
Measured: From baseline to 3 months post MI
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.
Measured: From baseline to 3 months post MI
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.
Measured: From baseline to 3 months post MI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Armaron Bio Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Grant McLachlan, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02557217
- Sponsor's protocol ID
- NP202-002
- Other IDs
- ACTRN12615000609550
- Status last verified
- Jun 2017
- First submitted
- 7 Sep 2015
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33851966
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02557217
- Acronym / sponsor ID
- NP202-002
- Conditions
- ST Elevation Myocardial Infarction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Armaron Bio Pty LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 23 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NP202 | Experimental | Drug: NP2021000mg oral NP202 daily for 90 days |
| Placebo | Placebo comparator | Other: PlaceboOral placebo daily for 90 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have had a confirmed ST elevation myocardial infarction (STEMI) in the previous 5 days, which met all of the following criteria;
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NP202Active | Drug | NP202 |
| PlaceboAlso: MicrocellulosePlacebo | Other | Placebo |
Primary outcome
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
4 secondary outcomes
Efficacy as measured by Change from baseline in LV end diastolic volume index (LVEDVi)
Time frame: From baseline to 3 months post MI
Efficacy as measured by Change from baseline in LV ejection fraction (LVEF)
Time frame: From baseline to 3 months post MI
Efficacy as measured by Change from baseline in LV diastolic function
Time frame: From baseline to 3 months post MI
Efficacy as measured by Change from baseline in relative infarct size
Time frame: From baseline to 3 months post MI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Derived from this study: PubMed 33851966Boyle 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grant McLachlan study director
Sponsor GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NP202 in people with ST Elevation Myocardial Infarction, run by Armaron Bio Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Grant McLachlan (+61 3 9652 2117, grant.mclachlan@armaronbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy as measured by Change from baseline in left ventricular end systolic volume index (LVESVi) (time frame: From baseline to 3 months post MI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02557217, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2017.