A Clinical Trial To Investigate The Effect Of EA-230 On Hospital Length Of Stay In Patients With … (NCT07357675) | Clinical Trial Compass
Not Yet RecruitingPhase 3
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.
United States, Belgium, Netherlands300 participantsStarted 2026-04-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients aged ≥18 years, both male and female.
✓. Patients scheduled for elective on-pump CABG with at least 3 bypasses, with or without valve replacement.
✓. For women of childbearing potential (WOCBP), agree to use adequate contraception17 from enrollment and up to 28 days after IMP administration, and must have a negative pregnancy test prior to entry into the trial.
✓. For male patients, agree to use adequate contraception and refrain from donating sperm from enrollment and up to 28 days after IMP administration.
✓. Willing and able to give written informed consent.
Exclusion criteria
✕. Patients undergoing non-elective on-pump CABG (i.e., emergency surgery). Emergency surgery is defined as planned surgery within 24 hours of diagnosis.
✕. Cardiogenic shock or hemodynamic instability that requires inotropes, vasopressors, or other mechanical devices, such as an intra-aortic balloon counter-pulsation (IABP), within 24 hours prior to surgery.
✕. Use of a left ventricular assist device (LVAD), or intra-aortic balloon pump or other cardiac devices, within 7 days prior to surgery.
✕. A requirement for any of the following within 7 days prior to surgery: defibrillator or permanent pacemaker, mechanical ventilation, IABP, LVAD, or other forms of mechanical circulatory support.
✕. Required cardiopulmonary resuscitation within 14 days prior to cardiac surgery.
✕. Known chronic liver disorder with Child-Pugh C classification.
✕. Confirmed or treated endocarditis requiring antimicrobial or antiviral treatment within 30 days prior to surgery or other current active infection requiring antimicrobial or antiviral treatment within 14 days prior to surgery.
✕. Ongoing sepsis (as defined by SEPSIS-3) within 2 weeks of screening or, in the opinion of the investigator, an untreated clinically significant infection (viral or bacterial) prior to or at Screening and before randomization.