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. (EasyBoost)
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.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 3
Contacts and Locations
Study Contact
Study Contact
- Name: Bas Ossenkoppele, Msc
- Phone Number: +31 620033017
- Email: bas.ossenkoppele@cr2o.nl
Study Contact Backup
- Name: Leonie Koomen, Msc
- Phone Number: +31610518323
- Email: leonie.koomen@cr2o.nl
Study Locations
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Ghent, Belgium
- UZ Gent
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Enschede, Netherlands
- Medisch Spectrum Twente
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Nijmegen, Netherlands
- Radboudumc
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London, United Kingdom
- St Thomas' Hospital
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- UPMC
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Placebo Comparator: Placebo
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Placebo administered intravenously for 4 hours
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Experimental: EA-230 90mg/kg/hour
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Intravenous administration of 90mg/kg per hour for 4 hours.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Required postoperative hospital length of stay
Time Frame: Up to 28 days
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Median postoperative duration, from the moment of first incision until the time when a patient is eligible to be discharged from the hospital.
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Up to 28 days
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Required postoperative ICU length of stay
Time Frame: Up to 28 days
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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.
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Up to 28 days
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Blood plasma levels of EA-230 in microgram per liter (µg/L)
Time Frame: Up to 4 hours after IMP administration (on Day 1)
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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. |
Up to 4 hours after IMP administration (on Day 1)
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the effect of EA-230 on the duration of moderate and severe POCs
Time Frame: Up to 28 days
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Median cumulative duration of moderate and severe Single Organ Outcome Measures (SOOMs) according to the European Perioperative Clinical Outcome (EPCO) definitions during the trial.
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Up to 28 days
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Hemodynamic stability via Net fluid balance
Time Frame: Up to 2 days (48 hours) after start of surgery (first incision)
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Median cumulative Net fluid balance (NFB) at the start of IMP administration (T0) and up to 24 and 48 hours thereafter.
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Up to 2 days (48 hours) after start of surgery (first incision)
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Hemodynamic stability via VIS score
Time Frame: Up to 2 days (48 hours) after start of surgery (first incision)
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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) |
Up to 2 days (48 hours) after start of surgery (first incision)
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Actual postoperative ICU and hospital length of stay
Time Frame: Up to 28 days
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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
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Up to 28 days
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Safety assessment of EA-230
Time Frame: Up to 28 days
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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).
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Up to 28 days
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Peter Pickers, Prof., Radboudmc
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- EasyBoost
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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