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.

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.

Overview

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.

Detailed description

The sites and vendor have been selected, and no further engagement regarding acquisition will be considered.

Interventions

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

Primary outcome measures

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

Secondary outcome measures (7)

• the effect of EA-230 on the duration of moderate and severe POCs [Time frame: Up to 28 days]
• Hemodynamic stability via Net fluid balance [Time frame: Up to 2 days (48 hours) after start of surgery (first incision)]
• Hemodynamic stability via VIS score [Time frame: Up to 2 days (48 hours) after start of surgery (first incision)]
• Required postoperative ICU length of stay [Time frame: Up to 28 days]
• Actual postoperative ICU and hospital length of stay [Time frame: Up to 28 days]
• Blood plasma levels of EA-230 in microgram per liter (µg/L) [Time frame: Up to 4 hours after IMP administration (on Day 1)]
• Safety assessment of EA-230 [Time frame: Up to 28 days]

Eligibility criteria

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.
• 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.
• 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;

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.

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 2 centers

• MAYO clinic — Rochester
• UPMC — Pittsburgh

Netherlands · 2 centers

• Medisch Spectrum Twente — Enschede
• RadboudUMC — Nijmegen

Belgium · 1 center

• UZ Gent — Ghent

United Kingdom · 1 center

• St Thomas' Hospital — London

Identifiers

NCT: NCT07357675 · EasyBoost

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗