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EasyBoostNCT07357675

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.

StatusRecruiting
PhasePhase 3
Primary completion (estimated)

At risk: Primary completion moved 4 months later.

See at-risk trials from EBI Anti Sepsis BV

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Recruitment opened Show 7 more changesShow less
    • Primary completion pushed from Jun 1, 2027 to Oct 1, 2027
    • Study completion pushed from Jul 1, 2027 to Dec 1, 2027
    • Start date changed from estimate of Aug 1, 2026 to Oct 29, 2026
    • Interventions: EA-230 90mg/kg/hour (Drug), Placebo (Drug) to EA-230 90mg/kg/hour (Drug), Placebo (Drug)
    • Eligibility criteria expanded, about 27 words
    • Secondary endpoints: details revised at 3 of 7 entries
    • Site details revised at 6 of 6 sites
  2. Start date: Apr 1, 2026 to Aug 1, 2026v2 Show 6 more changesShow less
    • Primary completion pushed from Mar 24, 2027 to Jun 1, 2027
    • Study completion pushed from May 2027 to Jul 1, 2027
    • Study sites: 5 to 6
    • Eligibility criteria shortened, about 11 words
    • Secondary endpoints: 10 to 7
    • Study description expanded, about 16 words
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Required postoperative hospital length of stay
Timeframe: Up to 28 days

Secondary (7)

the effect of EA-230 on the duration of moderate and severe POCs
Hemodynamic stability via Net fluid balance
Hemodynamic stability via VIS score
Required postoperative ICU length of stay
Actual postoperative ICU and hospital length of stay
Show 2 moreShow less
Blood plasma levels of EA-230 in microgram per liter (µg/L)
Safety assessment of EA-230

Arms and interventions

EA-230 90mg/kg/hourExperimental
PlaceboPlacebo comparator

Drugs: EA-230 90mg/kg/hour, Placebo

Sites

6 sites in 4 countries

Netherlands 2, United States 2, Belgium 1, United Kingdom 1