Not Yet RecruitingPhase 2Phase 3ACTRN12619000658112

A Phase II Randomised, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Oral NP202 in Reducing the Incidence of Atrial Fibrillation in Adults who have undergone Cardiac Surgery.

Sponsor

Armaron Bio Ltd

Enrollment

180 participants

Start Date

Jun 3, 2019

Study Type

Interventional

Conditions

Cardiac bypass graft surgery valve surgery Atrial Fibrillation

Summary

Atrial fibrillation (AF) remains a frequent complication after coronary artery bypass graft surgery (CABG) with a rate of occurrence from 10 to 40%.. This study will assess the ability of a novel treatment (NP202) to prevent post operative atrial fibrillation in comparison to a placebo. NP202 is a small molecule that inhibits a protein that is central to atrial fibrillation. Subjects will be treated with NP202 or placebo for 3 days prior to their surgery and through the duration of their hospital stay. After surgery, the amount of atrial fibrillation will be assessed during the in hospital recovery period.

Eligibility

Sex: Both males and femalesMin Age: 70 Yearss

Inclusion Criteria3

Are male or female and aged at least 70 years old at the time of consent.
Are scheduled for coronary arterial bypass graft and/or valve replacement surgery
Provide written informed consent prior to any study procedures and agree to adhere to all protocol requirements.

Exclusion Criteria7

Clinical history of chronic or paroxysmal atrial fibrillation.
Estimated glomerular filtration rate (eGFR) <30ml/min
Have received any investigational research agent within 30 days or 5 half-lives (whichever is longer) prior to the first dose of IP.
History of severe or life-threatening drug allergy and/or known drug hypersensitivity.
Current malignancy or previous malignancy that is likely to recur during the period of the study (with the exception of a past history of basal or squamous cell carcinomas).
Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C (note these will not be tested for)
Other than the protocol indication, history of or current clinically significant gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, oncological, immunodeficiency, neurological, metabolic, haematological, autoimmune or psychological disorder that, in the investigator’s opinion, would compromise subject safety or protocol compliance

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Interventions

NP202 1,000mg by oral capsule once daily, for up to 10 days Treatment will begin 3 days prior to the scheduled surgery and continue discharge from hospital. Adherence will be monitored by unused c

NP202 1,000mg by oral capsule once daily, for up to 10 days Treatment will begin 3 days prior to the scheduled surgery and continue discharge from hospital. Adherence will be monitored by unused capsule return and observation by study personnel.