drugset / Trial / 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.

NCT07357675 ↗

Phase 3 Not yet recruiting 300 enrolled EBI Anti Sepsis BV CR2O B.V. · collab
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2026-04-01
Primary completion
2027-03-24
Completion
2027-05

Drugs

EvaluationDrugModalityDoseRoute
Subject EA-230 Peptide 90 mg/kg Intravenous