None listed
Conditions
Brief 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.
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 capsule return and observation by study personnel.
Sponsors
Armaron Bio Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• 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 criteria
• 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
Outcome results
None listed