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New treatment option for Coronary Artery Bypass Graft
Official title Nicotinamide Mononucleotide in Patients Undergoing CABG Surgery
ClinicalTrials.gov ID: NCT07013591
What this study is testing
What is MIB-626?
MIB-626 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for coronary artery bypass graft.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The investigators will perform a phase 2a, randomized, double-blind, placebo-controlled clinical trial in adult patients undergoing elective coronary artery bypass grafting (CABG) surgery to investigate the effects of oral nicotinamide mononucleotide (NMN) administration on myocardial NAD+ concentrations and on postoperative markers of myocardial and kidney injury.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years
- Scheduled to undergo elective isolated CABG surgery with cardiopulmonary bypass (CPB)
- At increased risk of postoperative complications based on ≥1 of the following:
- Age ≥65 years
- eGFR \<45 ml/min/1.73m2
You likely can't join if
- Any of the following laboratory abnormalities at the time of screening:
- ALT \>3-fold the upper limit of normal
- eGFR \<30 ml/min/1.73m2 or ESKD on dialysis
- Hemoglobin \<8 g/dl
- History of gastric bypass or malabsorption
- Active alcohol or illicit substance use in the prior 6 months
See the full eligibility criteria
- Age ≥18 years
- Scheduled to undergo elective isolated CABG surgery with cardiopulmonary bypass (CPB)
- At increased risk of postoperative complications based on ≥1 of the following:
- Age ≥65 years
- eGFR \<45 ml/min/1.73m2
- Documented history of congestive heart failure or left ventricular ejection fraction (LVEF) ≤40% within 6 months before surgery
- Diabetes mellitus and urine albumin-to-creatinine ratio \>30 mg/g creatinine
- Peripheral arterial disease
- Anemia, defined as hemoglobin \<10 g/dl
- Prior cardiac surgery
- Any of the following laboratory abnormalities at the time of screening:
- ALT \>3-fold the upper limit of normal
- eGFR \<30 ml/min/1.73m2 or ESKD on dialysis
- Hemoglobin \<8 g/dl
- History of gastric bypass or malabsorption
- Active alcohol or illicit substance use in the prior 6 months
- Participation in an investigational trial to evaluate pharmaceuticals or biologics within the past 3 months or 5 half-lives, whichever is shorter
- Pregnant or breast-feeding
- Unwillingness to use contraception while taking study drug and for 8 weeks after the last dose for women of reproductive age or non-sterilized male participants who are sexually active with a female partner of...
- Current use of niacin \>100 mg/day or NMN, nicotinamide, or nicotinamide riboside at any dose
- Conflict with other research studies
- Any condition which, in the judgement of the investigator, might increase the risk to the participant
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.