Trial Review

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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
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
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
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
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
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.