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NOT YET RECRUITING
NCT07357675
PHASE3

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

View on ClinicalTrials.gov

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

DRUG

EA-230 90mg/kg/hour

Intravenous administration of 90mg/kg per hour for 4 hours.

DRUG

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