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An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Trial on the Effects of EA-230 on the Length of Hospital Stay Following On-Pump Coronary Artery Bypass Grafting Surgery
EU CTIS ID: 2025-525053-39-00
What this study is testing
The primary objective of this trial is to assess the effect of EA-230 on the required postoperative hospital Length of Stay (LoS)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 contraception 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
You likely can't join if
- Patients undergoing non-elective on-pump CABG (i.e., emergency surgery). Emergency surgery is defined as planned surgery within 24 hours of diagnosis.
- 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.
- Women who are pregnant, breastfeeding or planning to become pregnant during the trial or within 28 days after IMP administration.
- Previous receipt of EA-230.
- Known hypersensitivity to the IMP.
See the full eligibility criteria
Who can 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.
- For women of childbearing potential (WOCBP), agree to use adequate contraception 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
What rules you out
- Patients undergoing non-elective on-pump CABG (i.e., emergency surgery). Emergency surgery is defined as planned surgery within 24 hours of diagnosis.
- 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.
- Women who are pregnant, breastfeeding or planning to become pregnant during the trial or within 28 days after IMP administration.
- 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.
- Patients (or partners of patients) not willing to use a reliable method of contraception from enrollment and up to 28 days after IMP administration.
- Patients who are unable to communicate effectively in the local language of the trial site, at the discretion of the Investigator.
- 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.
- 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.
- 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.
- 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.
- Immuno-compromised patients, as self-reported or as observed in medical records, including patients: a. with solid organ transplantation. b. known to be positive for human immunodeficiency virus (HIV). c. that use immunosuppressive drugs or have received recent chemotherapy, at the discretion of the Investigator and including patients; i. with active malignancy who have undergone chemotherapy within 30 days prior to trial entry. ii. 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.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.