Coronary Artery Disease (CAD)Phase 3EasyBoostNCT07357675
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.
A Phase 3 study testing EA-230 90mg/kg/hour in people with Coronary Artery Disease (CAD) and Coronary Artery Bypass Graft Surgery(CABG), run by EBI Anti Sepsis BV at 6 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease (CAD), Coronary Artery Bypass Graft Surgery(CABG)
- What is being tested?
- EA-230 90mg/kg/hour
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 1 Aug 2026to 1 Jul 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Willing and able to give written informed consent.
Who cannot join
- 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.
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- 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.
- Immuno-compromised patients, as self-reported or as observed in medical records, including patients:
- with solid organ transplantation.
- known to be positive for human immunodeficiency virus (HIV).
- that use immunosuppressive drugs or have received recent chemotherapy, at the discretion of the Investigator and including patients;
- with active malignancy who have undergone chemotherapy within 30 days prior to trial entry.
- receiving chronic corticosteroid treatment equivalent to a prednisone dose of 10 mg or higher per day, within 30 days prior to trial entry, or an equivalent dose of another corticosteroid or any other anti-inflammatory or inflammation-suppressing medications such as interleukin blockers, methotrexate or similar therapies. Non-Steroidal Anti-Inflammatory Drugs are not exclusionary.
- Patients with hematological disorders (known disorders from myeloid and/or lymphoid origin, leucopenia (both active and in remission)).
- Known severe renal disease requiring dialysis, or a known estimated Glomerular Filtration Rate (eGFR) prior to admission of < 20 ml/min/1.73 m2.
- Previous receipt of EA-230.
- Known hypersensitivity to the IMP.
- Use of any investigational drug within 1 month or 5 half-lives of said investigational drug (whichever is longer) prior to IMP administration in this trial. Participation in an observational clinical trial is not exclusionary.
- Women who are pregnant, breastfeeding or planning to become pregnant during the trial or within 28 days after IMP administration (WOCBP must have a negative pregnancy test prior to entry into the trial).
- Female patients of childbearing potential who are not willing/able to use adequate contraception and refrain from donating ova from enrolment and up to 28 days after IMP administration (contraceptive requirements are detailed in Annex 5. Contraceptive Guidance).
- Male patients who are not willing/able to use adequate contraception (if their partners is of childbearing potential) and refrain from donating sperm from enrolment and up to 28 days after IMP administration (contraceptive requirements are detailed in Annex 5. Contraceptive Guidance).
- Inability to personally provide written informed consent.
- Known or suspected of not being able to comply with the trial protocol, at the discretion of the Investigator.
- Any other condition which, in the Investigator's opinion, will interfere with completion of the trial.
- Being an employee of the Investigator or trial site with direct involvement in the proposed trial or other studies under the direction of that Investigator or trial site or being a family member of an employee of the Investigator with direct involvement in the proposed trial.
Trial locations and contacts
6 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 4 countries
United States2 sites
UPMC
Pittsburgh, Pennsylvania, 15213
MAYO clinic
Rochester, Minnesota, 55905
About this study
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.
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.
Read the detailed description
The sites and vendor have been selected, and no further engagement regarding acquisition will be considered.
- Being tested
- EA-230 90mg/kg/hour, Placebo
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EA-230 90mg/kg/hourDrug
Intravenous administration of 90mg/kg per hour for 4 hours.
PlaceboDrug
Placebo administered intravenously for 4 hours
| Study group | Role | What they receive |
|---|---|---|
| EA-230 90mg/kg/hour | Experimental | Not described Receives: Drug: EA-230 90mg/kg/hour |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Required postoperative hospital length of stay
Median postoperative duration, from the moment of first incision until the time when a patient is eligible to be discharged from the hospital.
Measured: Up to 28 days
Secondary outcomes (7)
the effect of EA-230 on the duration of moderate and severe POCs
Median cumulative duration of moderate and severe Single Organ Outcome Measures (SOOMs) according to the European Perioperative Clinical Outcome (EPCO) definitions during the trial.
Measured: Up to 28 days
Hemodynamic stability via Net fluid balance
Median cumulative Net fluid balance (NFB) at the start of IMP administration (T0) and up to 24 and 48 hours thereafter.
Measured: Up to 2 days (48 hours) after start of surgery (first incision)
Hemodynamic stability via VIS score
Cumulative dose of vasopressors and inotropes used and vasopressor-inotropic scores at the start of IMP administration (T0) and up to 24 and 48 hours thereafter, compared between treatment arms.
Up to 2 days (48 hours) after start of surgery (first incision)
Measured: Up to 2 days (48 hours) after start of surgery (first incision)
Required postoperative ICU length of stay
Median postoperative duration, from the moment of first incision until the time when a patient is eligible to be discharged from the ICU and transferred to the general ward.
Measured: Up to 28 days
Actual postoperative ICU and hospital length of stay
Median postoperative duration, from the moment of first incision until the time when a patient is actually discharged from the ICU, and discharged from the hospital
Measured: Up to 28 days
Blood plasma levels of EA-230 in microgram per liter (µg/L)
Blood plasma levels of EA-230 measured immediately before the end of EA-230 infusion (T4) in all patients.
Blood plasma levels of EA-230 measured at T0, T0.5, T1, T2, T3 and T4 in a subset of patients in the Netherlands.
Only venous blood is sampled to determine blood plasma levels.
Measured: Up to 4 hours after IMP administration (on Day 1)
Safety assessment of EA-230
Incidence of treatment emergent (Serious) Adverse Events and Adverse Drug Reactions during the trial period. Coded using the Medical Dictionary for Regulatory Activities (version 28 or higher) and graded according to the Common Terminology Criteria for Adverse Events (V6.0).
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Placebo-Controlled Phase III Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EBI Anti Sepsis BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CR2O B.V.
- Responsible party
- Sponsor
- Investigators
- Peter Pickers, Prof., Principal investigator, Radboudmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357675
- Sponsor's protocol ID
- EasyBoost
- Acronym
- EasyBoost
- Status last verified
- Jul 2026
- First submitted
- 16 Jan 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD might be shared in the future, this is currently undecided. This field will be updated in case the data will be shared in the future.