AuthorisedTherapeutic confirmatory (Phase III)Interventional

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

This study is a major clinical trial looking at a new medicine called EA-230. It's designed to see if EA-230 can help people leave the hospital sooner after they've had a type of heart surgery known as coronary artery bypass grafting (CABG). This surgery is done to improve blood flow to the heart in people with coronary artery disease. Researchers will compare patients who receive EA-230 with those who receive a 'dummy' treatment (placebo) to fairly assess the medicine's effects. The main goal is to measure how long patients stay in the hospital after their operation and to check for any side effects.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

EBI Anti Sepsis B.V.

Enrolment target

150

Start

29 Apr 2026

Coronary artery disease

What is this study about?

When people have coronary artery bypass grafting (CABG) surgery, they often need to stay in hospital for a while afterwards to recover. This study is exploring whether a new medicine, called EA-230, might help patients recover more quickly from this type of heart surgery and reduce their hospital stay.

Coronary artery disease is a common condition where the blood vessels supplying the heart become narrowed or blocked. CABG surgery helps by creating new routes for blood to flow around these blockages, improving the heart's blood supply. The study is a 'Phase III' trial, which means it's a large, important study designed to confirm if a new treatment is effective and safe before it can be made widely available.

To make sure the results are fair and reliable, this study is 'double-blind' and 'placebo-controlled'. This means that neither the patients nor their doctors will know whether they are receiving EA-230 or a dummy treatment (which looks exactly like the medicine but contains no active drug). This helps to prevent any bias in the results. Researchers will be carefully monitoring how long patients stay in hospital and in the intensive care unit (ICU), as well as checking for any side effects or other health changes.

Key takeaways

This study is testing a new medicine (EA-230) for people having heart bypass surgery.
The main goal is to see if EA-230 can shorten the time people need to stay in hospital.
It's a major study (Phase III) to check if the medicine is effective and safe.
Neither you nor your doctors will know if you're getting the medicine or a placebo (dummy treatment).
Participation involves close monitoring during your hospital stay and recovery.
You can withdraw from the study at any time.

Who may be eligible?

To take part in this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

You would be considered for this study if you are scheduled to have coronary artery bypass grafting (CABG) surgery, which is a type of heart operation where doctors use grafts to improve blood flow to your heart.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you scheduled to have coronary artery bypass grafting (CABG) surgery?
Do you have coronary artery disease?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the study medicine, EA-230, or a placebo (a dummy treatment). This would be given to you during your hospital stay for heart surgery. You would be monitored closely by the medical team throughout your recovery. This will involve regular checks on your health, including blood tests and assessments of how you are recovering and when you are ready to leave the ICU and then the hospital. The total duration of your participation would cover your hospital stay and any follow-up assessments needed before you are fully discharged from the study.

Potential risks and benefits

Taking part in this study might offer a potential benefit if EA-230 helps you recover faster and reduces your time in hospital. However, as with any new medicine, there could be risks of side effects. The research team will carefully monitor you for any problems. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Belgium
—
Unverified
Netherlands

Common questions

What is EA-230?

EA-230 is a new medicine being tested to see if it helps people recover more quickly after heart surgery.

What is 'heart bypass surgery'?

Heart bypass surgery (Coronary Artery Bypass Grafting) is an operation to improve blood flow to your heart if your arteries are narrowed or blocked.

What does 'double-blind' mean?

It means neither you nor your doctor will know if you're getting the study medicine or a dummy treatment, to keep the results fair.

How long might I be in the study?

The study participation mainly covers your hospital stay and recovery period until you are fully discharged from care related to the study.

Can I stop taking part if I change my mind?

Yes, you can choose to leave the study at any time without it affecting your medical care.