Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ACTRN12615000609550 | Registry Identifier | Australian New Zealand Clinical Trials Registry |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NP202 | Experimental | 1000mg oral NP202 daily for 90 days |
|
| Placebo | Placebo Comparator | Oral placebo daily for 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NP202 | Drug | Active |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Efficacy as measured by Change from baseline in LV ejection fraction (LVEF) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Safety as assessed by changes in laboratory results |
Inclusion Criteria:
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.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Grant McLachlan | Contact | +61 3 9652 2117 | grant.mclachlan@armaronbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Grant McLachlan | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Hunter Hospital | Recruiting | Newcastle | New South Wales | 2305 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33851966 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
Placebo |
|
|
Change from baseline in LVEF as assessed by MRI at 3 months. |
| 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. | 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. | From baseline to 3 months post MI |
Biochemistry, haematology, prostate specific antigen (PSA), urinalysis
| At Baseline, Week 2, and Months 1, 2, 3 and 4 |
| 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 |
| 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 |
| 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 |
| 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 |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |