Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Condition(s) studied
Investigational drug(s) / intervention(s)
Roxadustat: Participants will receive oral roxadustat three times per week on nonconsecutive days for up to 2 weeks before surgery. The dose will be 70 mg for patients weighing 40 to \<60 kg and 100 mg for patients weighing ≥60 kg. No study drug will be administered on the day of surgery.
Placebo: Participants will receive oral placebo, matched to roxadustat in appearance, three times per week on nonconsecutive days for up to 2 weeks before surgery. The dosing regimen will be identical to that in the roxadustat group. No study drug will be administered on the day of surgery.
Study summary
Myocardial injury and infarction are common after cardiac surgery and are associated with worse perioperative outcomes. Hypoxia-inducible factor (HIF) is an important metabolic regulator that protects the myocardium. Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) approved for the treatment of anemia of chronic kidney disease; it enhances the hypoxia-protective pathway and erythropoiesis. We hypothesize that, in patients undergoing off-pump coronary artery bypass grafting (CABG), preoperative treatment with roxadustat may reduce postoperative myocardial injury or infarction. This pilot study is designed to test the feasibility of conducting a large randomized trial and to provide preliminary data on the potential effect of roxadustat on the occurrence of myocardial injury or infarction in patients undergoing off-pump CABG.
Eligibility
Primary outcome measure(s)
- Proportion of participants completing the trial intervention — Up to 30 days postoperatively.
Participants will be considered to have completed the trial intervention if they meet all of the following criteria: (1) they received trial medication according to randomization assignment; (2) they completed scheduled high-sensitivity cardiac troponin I measurements during the perioperative period; and (3) they completed the postoperative day 30 follow-up.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Peking University First Hospita | Beijing | Beijing Municipality |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07912801 on ClinicalTrials.gov ↗ ← All trials in China