NCT07357675

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.

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.

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: EBI Anti Sepsis BV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease (CAD)
• Coronary Artery Bypass Graft Surgery(CABG)

Interventions

Type	Name	Description
DRUG	EA-230 90mg/kg/hour	Intravenous administration of 90mg/kg per hour for 4 hours.
DRUG	Placebo	Placebo administered intravenously for 4 hours

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-03-24
• Completion: 2027-05-01
• First posted: 2026-01-22
• Last updated: 2026-01-22

Locations

5 sites across 4 countries: United States, Belgium, Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study