Table of contents
- Overview of the trial
- Who can participate
- Study design and phase
- What is being measured
- Trial status and size
Overview of the trial
This 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 heart bypass surgery.[1] The study is focused on the time patients stay in the hospital after surgery, which is also called length of stay.[1]
Who can participate
The trial is for patients with coronary artery disease who are scheduled for on-pump coronary artery bypass grafting surgery.[1] On-pump means the surgery uses a heart-lung machine during the operation.[1] The source data do not provide more detailed eligibility rules.[1]
Study design and phase
This is an interventional study, which means researchers give a treatment and compare outcomes between study groups.[1] It is randomized, so participants are assigned by chance to a group, and double-blind, so neither the patient nor the study team knows which treatment is given during the trial.[1] The trial is also placebo-controlled, which means one group receives an inactive solution for comparison.[1]
The study is in Phase 3, a later stage of research that usually checks how well a treatment works in a larger group and continues to collect safety information.[1] The planned enrollment is 300 participants.[1]
What is being measured
The main outcome is the median postoperative duration, measured from the first incision until the patient is eligible for hospital discharge.[1] In simple terms, the trial is asking whether the study treatment can shorten or change the time patients need to stay in the hospital after surgery.[1] The study uses ICU and hospital discharge criteria to decide when a patient is ready to leave the hospital.[1]
Trial status and size
The trial status is Authorised.[1] It is an international, multicenter study, which means it is planned across more than one center and in more than one location.[1] The available data describe one trial only, so the summary of evidence is limited to this single study.[1]
