Trial Review

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000609550
Ethics application status
Approved
Date submitted
29/05/2015
Date registered
11/06/2015
Date last updated
30/07/2021
Date data sharing statement initially provided
30/07/2021
Date results information initially provided
30/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public 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.
Scientific 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.
Secondary ID [1] 286468 0
Protocol NP202-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac remodelling post acute myocardial infarction 294655 0
Condition category
Condition code
Cardiovascular 294956 294956 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
NP202 oral capsules, 1000mg, once daily for 90 days.

50% of subjects will receive NP202.

Compliance will be assessed by capsule count.
Intervention code [1] 291552 0
Treatment: Drugs
Comparator / control treatment
Placebo capsules containing microcellulose, once daily for 90 days

50% of subjects will receive placebo.

Compliance will be assessed by capsule count.
Control group
Placebo

Outcomes
Primary outcome [1] 294708 0
To evaluate the efficacy of NP202 compared to placebo, when administered once daily for 3 months, in attenuating pathological left ventricular remodelling in patients post myocardial infarction (MI).

Assessed by cardiac magnetic resonance imaging (MRI)
Timepoint [1] 294708 0
At 3 months post baseline
Secondary outcome [1] 313905 0
To assess the safety and tolerability of NP202 compared to placebo, when administered once daily for 3 months to patients post MI.

Assessed by vital signs, medical history, physical examination, laboratory evaluations, 12-lead ECG, evaluation of adverse events and concomitant medications
Timepoint [1] 313905 0
AEs throughout study to 4 months post baseline
Assessments at D14, and months 1, 2, 3 and 4
Secondary outcome [2] 313906 0
To determine the pharmacokinetic levels of NP202 in a subset of 30 patients post MI.

Assessed by trough plasma samples.
Timepoint [2] 313906 0
Trough samples at D14, and months 1, 2 and 3

Eligibility
Key inclusion criteria
Participants who:

- Have had a confirmed ST elevation myocardial infarction (STEMI) in the previous 5 days, which met all of the following criteria;
* less than or equal to 0.2 mV ST elevation in 2 or more V1 – V6 leads with presentation in a maximum of 12 hours of onset of symptoms
* Troponin levels greater than 10 x upper limit of normal at the site’s local laboratory.
* Successfully revascularised with percutaneous coronary intervention (PCI)

- Have left ventricular dysfunction post STEMI as evidenced by left ventricular ejection fraction less than or equal to 40% confirmed by echocardiogram at screening.

- Are receiving guideline-directed medical therapy for acute MI and post-MI left ventricular dysfunction according to national cardiology society/heart association STEMI guidelines.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with:

- Known cardiomyopathy or heart failure prior to MI.

- Cardiogenic shock and/or systolic blood pressure less than 85mmHg at Screening.

- Clinical history of ejection fraction less than or equal to 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 MR imaging

- Estimated glomerular filtration rate (eGFR) less than 30ml/min

- Liver function tests 3 x upper limit of normal 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/10/2015
Actual
20/11/2015
Date of last participant enrolment
Anticipated
Actual
29/03/2018
Date of last data collection
Anticipated
31/08/2018
Actual
31/08/2018
Sample size
Target
147
Accrual to date
Final
147
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment outside Australia
Country [1] 6864 0
New Zealand
State/province [1] 6864 0
New Zealand
Country [2] 7563 0
United States of America
State/province [2] 7563 0
MI, MN, OH

Funding & Sponsors
Funding source category [1] 291034 0
Commercial sector/Industry
Name [1] 291034 0
Armaron Bio Pty Ltd
Country [1] 291034 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Armaron Bio Pty Ltd
Address
Level 1
120 Jolimont Road
East Melbourne VIC 3002
Country
Australia
Secondary sponsor category [1] 289719 0
None
Name [1] 289719 0
Address [1] 289719 0
Country [1] 289719 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292618 0
Hunter New England Health Research Ethics Committee
Ethics committee address [1] 292618 0
John Hunter Hospital
Lookout Road
New Lambton, NSW, 2305
Ethics committee country [1] 292618 0
Australia
Date submitted for ethics approval [1] 292618 0
29/05/2015
Approval date [1] 292618 0
25/08/2015
Ethics approval number [1] 292618 0

Summary
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). 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, so new drugs are needed. 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. It is hoped that NP202 will help to reduce the damage to the heart that is caused by a MI in humans.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56254 0
A/Prof Andrew Boyle
Address 56254 0
John Hunter Hospital
Lookout Rd
New Lambton 2305
NSW
Country 56254 0
Australia
Phone 56254 0
+61 2 4985 5316
Fax 56254 0
Email 56254 0
[email protected]
Contact person for public queries
Name 56255 0
Dr Grant McLachlan
Address 56255 0
Armaron Bio Pty Ltd
Level 1
120 Jolimont Road
East Melbourne VIC 3002
Country 56255 0
Australia
Phone 56255 0
+61 3 9652 2117
Fax 56255 0
Email 56255 0
[email protected]
Contact person for scientific queries
Name 56256 0
Dr Grant McLachlan
Address 56256 0
Armaron Bio Pty Ltd
Level 1
120 Jolimont Road
East Melbourne VIC 3002
Country 56256 0
Australia
Phone 56256 0
+61 3 9652 2117
Fax 56256 0
Email 56256 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.