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.

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
EBI Anti Sepsis BV
Study ID
NCT07357675
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Jan 2026
Primary completion
Mar 24, 2027
Completion
May 31, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: EA-230 90mg/kg/hour
  • Placebo Comparator: Placebo

Primary Outcome Measure

Required postoperative hospital length of stay [ Time Frame: Up to 28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MAYO clinicRochesterMinnesota55905-

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By research site
MAYO clinic· Rochester, MN

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