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A study to evaluate the effect of EA-230 on the hospital stay length for patients undergoing coronary artery bypass surgery for coronary artery disease.

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study examines the effects of a drug called EA-230 on patients with Coronary Artery Disease, a condition where the blood vessels supplying the heart become narrowed or blocked. The research focuses on individuals undergoing Coronary Artery Bypass Grafting, which is a type of surgery used to improve blood flow to the heart. During this procedure, a heart-lung machine is used to keep blood circulating while the heart is stopped, a method known as on-pump surgery.

The purpose of this study is to determine if EA-230 can reduce the amount of time a patient needs to stay in the hospital after surgery. Participants will receive either EA-230, which is given as a solution for infusion through an intravenous line, or a placebo. This is a randomized trial, meaning participants are assigned to a group by chance, and it is double-blind, meaning neither the patients nor the medical staff know which substance is being administered.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Participation in the trial
Participation begins following the scheduled coronary artery bypass grafting surgery, which is a procedure to improve blood flow to the heart.
A randomized process determines whether the administration of the test medication or a placebo occurs. a placebo is a substance that has no active medicinal effect, used here for comparison.
Step 2
Medication administration
The test medication, known as ea-230, is provided as a solution for infusion. this is administered through intravenous administration, which means the medicine is delivered directly into a vein.
The dosage for ea-230 is 180 mg/kg, meaning the amount is calculated based on body weight in milligrams per kilogram.
The alternative group receives a placebo consisting of sodium chloride (salt water).
Step 3
Monitoring and observations
The time spent in the intensive care unit (icu), a specialized hospital department for close monitoring, and the total hospital stay are recorded from the moment of the first surgical incision until discharge.
Measurements are taken regarding fluid balance (the amount of fluid entering and leaving the body) and the use of medications that support blood pressure or heart function.
blood plasma levels of ea-230 are measured to track the concentration of the medicine in the blood at specific time points during and after the infusion.
Any adverse events, which are unexpected medical occurrences, or adverse drug reactions, which are unwanted effects from the medication, are documented throughout the trial period.

Who can join the trial?

8 criteria

You must be 18 years of age or older.
You are scheduled for an elective on-pump CABG, which is a planned heart surgery performed while the heart is stopped and supported by a machine that breathes and pumps blood for you.
The surgery must involve at least three bypasses, which are procedures used to create new paths for blood to flow around blocked arteries.
The surgery may or may not include a valve replacement, which is a procedure to fix or replace a heart valve that is not working correctly.
Women who are able to become pregnant must agree to use effective birth control from the start of the study until 28 days after receiving the investigational medicinal product, which is the specific study drug being tested.
Women must have a negative pregnancy test before joining the study.
Men must agree to use effective birth control and must not donate sperm from the start of the study until 28 days after receiving the investigational medicinal product.
You must be willing and able to provide written informed consent, which means you agree to participate after being fully explained all the details, risks, and benefits of the study.

Who cannot join the trial?

23 criteria

Patients undergoing emergency coronary artery bypass graft (CABG), which is a type of heart surgery, if the surgery is not planned in advance or is scheduled within 24 hours of a diagnosis.
Patients with hematological disorders, which are conditions affecting the blood, such as problems with blood cells or low white blood cell counts (known as leucopenia).
Patients with severe renal disease (kidney disease) that requires dialysis (a process to clean the blood when kidneys fail) or those with a low estimated Glomerular Filtration Rate (eGFR), which is a measure of how well the kidneys are filtering waste.
Women who are currently pregnant, breastfeeding, or planning to become pregnant during the study or within 28 days after receiving the investigational medicinal product (IMP), which is the experimental drug being tested.
Anyone who has previously received the drug EA-230.
Patients with a known hypersensitivity, or an allergic reaction, to the study drug.
Patients who have used any other experimental drugs within the last month or within a specific timeframe based on how long the drug stays in the body (known as half-lives).
Patients, or their partners, who are unwilling to use a reliable form of contraception (birth control) from the start of the study until 28 days after receiving the drug.
Patients who cannot communicate effectively in the local language used at the study location.
Patients who are unable to personally sign the informed consent form, which is a document where you agree to participate after understanding the study.
Patients who, in the doctor's opinion, may not be able to follow the rules and steps of the study protocol.
Patients experiencing cardiogenic shock (a severe condition where the heart cannot pump enough blood) or hemodynamic instability (unstable blood pressure or blood flow) that requires the use of inotropes or vasopressors (medicines to support heart function or blood pressure) or mechanical heart devices.
Patients who have used a left ventricular assist device (LVAD), an intra-aortic balloon pump (IABP), or other heart-assisting machines within 7 days before surgery.
Patients who required a pacemaker (a device to control heart rhythm), mechanical ventilation (a machine to help with breathing), or other heart support devices within 7 days before surgery.
Patients who needed cardiopulmonary resuscitation (CPR) within 14 days before their heart surgery.
Patients with a known chronic liver disorder classified as Child-Pugh C, which is a way of measuring how severe liver disease is.
Patients with endocarditis (an infection of the heart lining) that was treated with infection-fighting medicine within 30 days before surgery, or any other active infection requiring such medicine within 14 days before surgery.
Patients with sepsis (a life-threatening reaction to an infection) within 2 weeks of being screened, or those with an untreated significant infection.
Patients who are immuno-compromised, meaning their immune system is weakened, including those who have had an organ transplant, have HIV, or use medicines that suppress the immune system.
Patients who have had chemotherapy (treatment for cancer) within 30 days of joining the study.
Patients taking long-term corticosteroids (strong anti-inflammatory medicines) at a high dose, such as 10 mg of prednisone or higher per day, within 30 days of entering the study.
Employees of the study site or their family members who are directly involved in the research.
Any other health condition that the doctor believes will prevent the person from completing the study.

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Verified sites

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Verified
Stichting Radboud University Medical Center
Nijmegen, The Netherlands
Responsive
Universitair Ziekenhuis Gent
Gent, Belgium

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Investigated drugs

EA-230 is an experimental treatment being studied to see if it can help reduce the amount of time a patient needs to stay in the hospital after undergoing heart bypass surgery. It is given directly into a vein through an infusion.

(2S)-2-[[2-[[(2S)-5-AMINO-2-[[(2S)-2-AMINOPROPANOYL]AMINO]-5-OXOPENTANOYL]AMINO]ACETYL]AMINO]-3-METHYLBUTANOIC ACID

What is already known about the treatment

EA-230
This medication is an experimental treatment delivered as a liquid solution through an intravenous infusion directly into a vein. It is currently being studied in late-stage clinical trials to see if it can help patients recover faster after heart bypass surgery. As a specialized peptide, it works at a molecular level to protect cells and tissues from damage during high-stress medical procedures. This substance is classified as a research-phase therapeutic agent aimed at improving outcomes for people with coronary artery disease.
NaCl 29 mg/ml in water for injection
This substance is a saline solution used as a placebo, which is an inactive substance given to participants in a study to compare against the experimental drug. It is administered through an intravenous infusion to mimic the delivery method of the test medication. Because it contains no active medicinal ingredients, it has no direct therapeutic effect or specific mechanism of action on the body's molecular processes. It serves as a control tool in clinical research to ensure the accuracy of the study results.

Investigated diseases

Coronary artery disease - This condition occurs when the major blood vessels that supply the heart become damaged or diseased. This process is often caused by the buildup of fatty deposits called plaque along the inner walls of the arteries. As these deposits grow, they can narrow the vessels and restrict the flow of blood to the heart muscle. Over time, the reduced blood supply can lead to various heart-related issues. The condition typically progresses gradually as the arterial narrowing becomes more significant.