NCT02557217

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

June 28, 2017

Status Verified

June 1, 2017

Enrollment Period

2.2 years

First QC Date

September 7, 2015

Last Update Submit

June 26, 2017

Conditions

ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Efficacy as measured by Change from baseline in LV end diastolic volume index (LVEDVi)

    From baseline to 3 months post MI

  • Efficacy as measured by Change from baseline in LV ejection fraction (LVEF)

    From baseline to 3 months post MI

  • Efficacy as measured by Change from baseline in LV diastolic function

    From baseline to 3 months post MI

  • Efficacy as measured by Change from baseline in relative infarct size

    From baseline to 3 months post MI

Other Outcomes (6)

  • Safety as assessed by occurrence of adverse events (AE)

    From baseline to end of study (4 months)

  • Safety as assessed by changes in laboratory results

    At Baseline, Week 2, and Months 1, 2, 3 and 4

  • Safety as assessed by changes in physical examination

    At Baseline, Week 2, and Months 1, 2, 3 and 4

  • +3 more other outcomes

Study Arms (2)

NP202

EXPERIMENTAL

1000mg oral NP202 daily for 90 days

Drug: NP202

Placebo

PLACEBO COMPARATOR

Oral placebo daily for 90 days

Other: Placebo

Interventions

NP202DRUG

Active

NP202
PlaceboOTHER

Placebo

Also known as: Microcellulose
Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John Hunter Hospital

Newcastle, New South Wales, 2305, Australia

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33851966DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Grant McLachlan

    Sponsor GmbH

    STUDY DIRECTOR

Central Study Contacts

Grant McLachlan

CONTACT

+61 3 9652 2117grant.mclachlan@armaronbio.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2015

First Posted

September 23, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2017

Study Completion

February 1, 2018

Last Updated

June 28, 2017

Record last verified: 2017-06

Locations

AU(1)