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Not yet recruitingPHASE3INTERVENTIONAL

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.

This important study is investigating a new medicine called EA-230. The aim is to see if EA-230 can help people recover more quickly and have fewer issues after a type of heart surgery known as coronary artery bypass grafting (CABG). In earlier tests, people who received EA-230 during their surgery spent less time in intensive care and overall in hospital, and had fewer serious difficulties compared to those who received a dummy treatment. This new study is a larger trial (Phase 3) that will test EA-230 in more people to confirm if it's truly effective and safe for future use, and to see if it makes a real difference to patient recovery times.

At a glance

Status
Not yet recruiting
Phase
PHASE3
Sponsor
EBI Anti Sepsis BV
Enrolment target
300
Start
01 Apr 2026
Estimated completion
01 May 2027

What is this study about?

This study is looking at a new medicine called EA-230, which we hope might help people get better faster after a specific type of heart surgery. This surgery is called coronary artery bypass grafting, or CABG for short. It's a common operation for people with coronary artery disease, where blood vessels around the heart get narrowed or blocked. During CABG surgery, doctors take a healthy blood vessel from another part of your body and use it to go around, or 'bypass,' the blocked section, helping blood flow to your heart.

In earlier, smaller tests, those who received EA-230 during their CABG surgery seemed to spend less time in the intensive care unit and less time in the hospital overall. They also had fewer serious problems after their operation compared to people who received a 'placebo' – which looks like the real medicine but doesn't contain any active ingredients. The early tests also showed that EA-230 was safe and didn't cause many side effects.

Because these early results were promising, we're now doing a bigger study, called a Phase 3 trial. The main goal of this larger study is to confirm if EA-230 really does help people recover faster and is safe to use for many people. If it works well, it could become a new way to improve recovery for patients having bypass surgery.

Key takeaways

  • This study tests a new medicine, EA-230, for heart bypass surgery.
  • It aims to shorten hospital stays and reduce surgery complications.
  • Participation is for adults having planned bypass surgery.
  • You will receive either EA-230 or a dummy treatment (placebo).
  • The study lasts about 71 days with 10 total visits.
  • Taking part is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older, and planning to have heart bypass surgery. This surgery must be planned in advance (not an emergency) and involve at least three 'bypasses,' which means creating three new routes for blood flow around your heart. Sometimes, this surgery also includes replacing a heart valve, and that's okay too.

There are also some important safety checks. For women who could become pregnant, you'll need to agree to use effective contraception (birth control) during and for a short time after the study medicine is given, and have a negative pregnancy test before starting. Men will also need to use contraception and not donate sperm for the same period. Everyone joining must be able to understand the study and agree to take part in writing.

However, some people won't be able to join. This includes if you're having emergency heart surgery, have very unstable heart health that needs strong medication or special devices just before surgery, or if you've recently needed CPR. People with severe liver disease or active serious infections won't be able to take part, nor will those with weakened immune systems. These rules are in place to make sure the study is as safe as possible for everyone involved.

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.

  1. Are you 18 or older?
  2. Are you scheduled for planned heart bypass surgery (not an emergency)?
  3. Is your planned bypass surgery for at least 3 bypasses?
  4. If female and able to get pregnant, are you willing to use contraception during the study?
  5. Do you not have active, severe infections or very serious liver disease?
  6. Are you generally stable in terms of your heart health before surgery?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it will last for about 71 days in total, from the very beginning until your final check-up. Throughout this time, you'll have 10 appointments. Seven of these visits will happen while you're in the hospital for your surgery, and these will include checks related to the study. There will also be an initial screening visit to see if you can join, a visit just before your operation, and two follow-up visits that can be done remotely, meaning you might not need to come to the hospital for them.

During the study, you'll receive either the new medicine, EA-230, or a 'placebo' (a dummy treatment). You won't know which one you're getting, and neither will your doctors. This is called 'double-blind' and helps us get the most accurate results. The choice between EA-230 and the placebo is made completely by chance, like flipping a coin. You'll be closely monitored throughout your hospital stay and during the follow-up period to see how you're recovering and if the medicine is making a difference.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving state-of-the-art medical care and perhaps a faster recovery or fewer complications after your surgery if you receive EA-230. However, there's no guarantee that you will receive the active medicine or that it will benefit you. There are potential risks, too, just like with any medicine or medical procedure. We don't yet know all the possible side effects of EA-230, although early studies suggest it has been safe and well-tolerated. Your doctors and the study team will explain any known risks to you in detail. It's very important to remember that participating is entirely your choice, and you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • MAYO clinic
    Verified postcode
    Rochester, United States
  • UZ Gent
    Verified postcode
    Ghent, Belgium
  • Medisch Spectrum Twente
    Verified postcode
    Enschede, Netherlands
  • RadboudUMC
    Verified postcode
    Nijmegen, Netherlands
  • St Thomas' Hospital
    Verified postcode
    London, United Kingdom

Common questions

What is Coronary Artery Disease (CAD)?

CAD is when the blood vessels that supply blood to your heart become narrowed or blocked, which can lead to heart problems.

What is CABG surgery?

CABG, or 'bypass surgery,' is an operation to create new paths for blood to flow around blocked arteries to your heart, improving blood supply.

What does 'double-blind' mean in this study?

It means neither you nor your doctors will know if you're receiving the new medicine (EA-230) or a dummy treatment (placebo). This helps keep the study fair and accurate.

How long will I be in the study?

The study will last approximately 71 days in total, including your hospital stay and follow-up appointments.

Can I leave the study if I change my mind?

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

How to find out more

Bas Ossenkoppele, Msc

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Clinical Trial To Investigate The Effect Of EA-230 On Hosp…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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