EA-230 for Coronary Artery Disease

(EasyBoost Trial)

Not yet recruiting at 4 trial locations

Overseen By Leonie Koomen, Msc

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: EBI Anti Sepsis BV

Must not be taking: Immunosuppressants, Chemotherapy, Corticosteroids, others

Disqualifiers: Emergency surgery, Cardiogenic shock, Sepsis, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 11

Duration: During hospital stay

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test whether a new treatment, EA-230, can help people recover faster and experience fewer complications after coronary artery bypass surgery, a procedure that improves heart blood flow. Previous studies showed that EA-230 might reduce ICU and hospital stays and lower the risk of serious post-surgery issues. This trial will compare EA-230 with a placebo (an inactive treatment) to confirm its effectiveness and safety. Suitable candidates for this trial are those scheduled for elective bypass surgery with at least three bypasses, who have not recently undergone emergency surgery or experienced serious health complications. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on certain treatments like immunosuppressive drugs or have had recent chemotherapy, you may not be eligible to participate.

Is there any evidence suggesting that EA-230 is likely to be safe for humans?

Research has shown that EA-230 is safe and well-tolerated for people undergoing heart surgery. In one study, patients who received EA-230 during surgery experienced fewer serious problems and spent less time in the ICU and hospital compared to those who received a placebo. Another study confirmed the safety of EA-230 for heart surgery patients, although it did not affect certain blood tests. Overall, these findings suggest that EA-230 is safe for heart surgery patients, with few side effects reported. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for coronary artery disease focus on improving blood flow through methods like cholesterol-lowering drugs, blood thinners, or procedures like angioplasty. But EA-230 works differently, targeting inflammation within the arteries. Researchers are excited about EA-230 because it offers a novel approach by utilizing an anti-inflammatory mechanism, potentially reducing complications and improving heart health without the need for invasive procedures. This unique action sets it apart from current options and could lead to better outcomes for patients with coronary artery disease.

What evidence suggests that EA-230 might be an effective treatment for coronary artery disease?

Research has shown that EA-230, which participants in this trial may receive, can help people recover faster after heart surgery. In a previous study, patients who received EA-230 during heart bypass surgery spent less time in the ICU and hospital and experienced fewer serious complications compared to those who received a placebo. The study also found EA-230 to be safe and well-tolerated. While it did not affect levels of interleukin-6, it appeared to improve kidney function. These findings suggest that EA-230 may effectively enhance recovery for individuals undergoing heart surgery. ^{1 2 3 6 7}

Who Is on the Research Team?

Peter Pickers, Prof.

Principal Investigator

Radboudmc

Are You a Good Fit for This Trial?

This trial is for patients with Coronary Artery Disease who are scheduled for bypass surgery. Participants should be adults able to give consent and follow the trial procedures. Details on specific inclusion or exclusion criteria are not provided, but typically these would involve health status, previous treatments, and risk factors.

Inclusion Criteria

I agree to use contraception and not donate sperm until 28 days after the last treatment.

Willing and able to give written informed consent

I am scheduled for a heart bypass surgery with at least 3 bypasses, valve replacement may or may not be included.

Exclusion Criteria

I have not used any heart support devices like LVAD within the last week.

Known or suspected inability to comply with the trial protocol

I have previously received EA-230.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Pre-operative

Participants undergo pre-operative assessments and preparation for surgery

1 week

1 visit (in-person)

Treatment

Participants receive EA-230 or placebo during Coronary Artery Bypass Grafting (CABG) surgery

During hospital stay

7 visits (in-person during hospital stay)

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days

2 remote visits

What Are the Treatments Tested in This Trial?

Interventions

• EA-230

Trial Overview

The trial tests EA-230, a new therapy aimed at reducing hospital stay and complications after bypass surgery compared to a placebo. It's a Phase III study that's double-blind and randomized; neither doctors nor participants know who gets the real treatment.

How Is the Trial Designed?

Group I: EA-230 90mg/kg/hour Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

EBI Anti Sepsis BV

Lead Sponsor

CR2O B.V.

Collaborator

Trials

1

Recruited

150+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07357675?term=heart+disease

A Clinical Trial To Investigate The Effect Of EA-230 On ...

EA-230 is a new therapy that may help people recover faster and have fewer problems after bypass surgery. In an earlier clinical trial, ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33591006/

Safety and Efficacy of EA-230 in Cardiac Surgery Patients

EA-230 was safe in patients undergoing on-pump cardiac surgery. It did not modulate interleukin-6 plasma concentrations but appeared to exert beneficial renal ...

3.

journals.lww.com

journals.lww.com/ccmjournal/fulltext/2021/05000/safety_and_efficacy_of_human_chorionic.8.aspx

Safety and Efficacy of Human Chorionic Gonadotropin...

EA-230 was safe in patients undergoing on-pump cardiac surgery. It did not modulate interleukin-6 plasma concentrations but appeared to exert beneficial renal ...

4.

researchprotocols.org

researchprotocols.org/2019/2/e11441/

The Safety, Tolerability, and Effects on the Systemic ...

Conclusions: This adaptive phase 2 clinical study is designed to test the safety and tolerability of EA-230 in patients undergoing cardiac ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8043513/

A Randomized Double-Blind Placebo-Controlled Study - PMC

Safety and efficacy of human chorionic gonadotropin hormone-derivative EA-230 in cardiac surgery patients: a randomized double-blind placebo-controlled study.

6.

sciencedirect.com

sciencedirect.com/org/science/article/pii/S192907481900132X

The Safety, Tolerability, and Effects on the Systemic ...

This adaptive phase 2 clinical study is designed to test the safety and tolerability of EA-230 in patients undergoing cardiac surgery. In ...

7.

ahajournals.org

ahajournals.org/doi/10.1161/CIR.0000000000001394

State of the Art: Evaluation and Medical Management ...

The updated 2022 CAD-RADS 2.0 classification (Coronary Artery Disease Reporting and Data System) follows a framework of stenosis, plaque burden, ...