In short
Clinical trials are investigating "(2S)-2-[[2-[[(2S)-5-AMINO-2-[[(2S)-2-AMINOPROPANOYL]AMINO]-5-OXOPENTANOYL]AMINO]ACETYL]AMINO]-3-METHYLBUTANOIC ACID" in patients with coronary artery disease. The study is designed to evaluate whether it can affect recovery after on-pump coronary artery bypass grafting surgery, with a focus on hospital stay after surgery.
Key points
- One clinical trial is studying "(2S)-2-[[2-[[(2S)-5-AMINO-2-[[(2S)-2-AMINOPROPANOYL]AMINO]-5-OXOPENTANOYL]AMINO]ACETYL]AMINO]-3-METHYLBUTANOIC ACID" in people with coronary artery disease who are having on-pump coronary artery bypass grafting surgery. It is a Phase 3, randomized, double-blind, placebo-controlled study. The main goal is to see whether the study treatment changes the time patients stay in the hospital after surgery. The trial plans to enroll 300 people. The study compares EA-230 with placebo. The key result measured is the median postoperative time from first incision until the patient is ready for hospital discharge.
Trial overview
One clinical trial is listed for "(2S)-2-[[2-[[(2S)-5-AMINO-2-[[(2S)-2-AMINOPROPANOYL]AMINO]-5-OXOPENTANOYL]AMINO]ACETYL]AMINO]-3-METHYLBUTANOIC ACID". The study is an interventional trial, which means researchers give a treatment and then measure the results.
The trial is focused on people with coronary artery disease who are having on-pump coronary artery bypass grafting surgery.
Study design and treatment groups
This study is a Phase 3 trial, which is a later-stage study in a larger group of patients.
It is described as randomized, double-blind, and placebo-controlled.
Randomized means patients are assigned by chance to a study group. Double-blind means neither the patient nor the study team knows which treatment is given. Placebo-controlled means one group receives a comparison treatment that does not contain the active study drug.
- One group receives EA-230 given by intravenous administration, which means through a vein.
- The other group receives NaCl 29 mg/ml in water for injection, which is the placebo used for comparison.
Who can participate
The source data says the trial is for people with coronary artery disease who are undergoing on-pump coronary artery bypass grafting surgery.
No more detailed inclusion or exclusion rules are provided in the trial data, so the full eligibility list is not available here.
What is being measured
The main goal of the trial is to assess the effect of the study treatment on postoperative hospital length of stay, which means how long a patient stays in the hospital after surgery.
The primary outcome is the median postoperative duration from the first incision until the patient is eligible to be discharged from the hospital.
Median means the middle value in a group of results. The study compares this outcome between the treatment groups using the trial's discharge criteria.
Trial status and size
The trial status is Authorised.
The planned enrollment is 300 people.