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A Clinical Trial To Investigate The Effect Of EA-230 On Hospital Length Of Stay In Patients With Coronary Artery Disease (CAD) Undergoing Coronary Artery Bypass Grafting (CABG) Surgery.
Sponsor: EBI Anti Sepsis BV
Summary
EA-230 is a new therapy that may help people recover faster and have fewer problems after bypass surgery. In an earlier clinical trial, participants who received EA-230 during Coronary Artery Bypass surgery stayed in the Intensive Care Unit (ICU) and the hospital for a shorter time and had fewer serious complications, compared to those who received a placebo (an inactive therapy). The use of EA-230 was safe and well tolerated. This trial will test EA-230 in more participants to see if it really works and is safe to use in the future. This is a Phase III trial. It will take place in multiple locations and will follow a double-blind, randomized, placebo-controlled clinical design, meaning neither doctors nor participants will know whether they receive EA-230 or placebo during the trial. Assignment to EA-230 or placebo occurs by chance, like throwing dice. The total duration of the trial, including medical check-ups, will be approximately 71 days. There is a total of 10 visits, including a screening-, a pre-operative-, and 2 remote visits. 7 of these visits are during your stay at the hospital.
Official title: A Clinical Trial To Investigate The Effect Of EA-230 On Hospital Length of Stay In Patients With Coronary Artery Disease (CAD) Undergoing Coronary Artery Bypass Grafting (CABG) Surgery.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-08-01
Completion Date
2027-07-01
Last Updated
2026-07-27
Healthy Volunteers
No
Interventions
EA-230 90mg/kg/hour
Intravenous administration of 90mg/kg per hour for 4 hours.
Placebo
Placebo administered intravenously for 4 hours
Locations (6)
MAYO clinic
Rochester, Minnesota, United States
UPMC
Pittsburgh, Pennsylvania, United States
UZ Gent
Ghent, Belgium
Medisch Spectrum Twente
Enschede, Netherlands
RadboudUMC
Nijmegen, Netherlands
St Thomas' Hospital
London, United Kingdom