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NOT YET RECRUITING
NCT07912801
PHASE4

Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery

Sponsor: Peking University First Hospital

View on ClinicalTrials.gov

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.

Official title: Effect of Preoperative Roxadustat on Myocardial Injury After Off-Pump Coronary Artery Bypass Graft Surgery: A Pilot Randomized Trial

Key Details

Gender

All

Age Range

45 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-11

Completion Date

2027-12

Last Updated

2026-11-03

Healthy Volunteers

No

Conditions

Coronary Artery DiseaseCoronary Artery Bypass GraftingHypoxia-Inducible Factor 1, Alpha SubunitProlyl-Hydroxylase InhibitorsMyocardial IschemiaMyocardial Infarction Postoperative

Interventions

DRUG

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.

DRUG

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.

Locations (1)

Peking University First Hospita

Beijing, Beijing Municipality, China