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Not yet taking people in ChinaPhase 4

Roxadustat before off-pump bypass surgery to study heart muscle injury

Tests roxadustat given before bypass surgery in adults with coronary artery disease.

Plain-language title generated from the registry record
Registry title: Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery

Key facts

Where
Beijing, ChinaSee the site
Phase
Phase 4

Where in China

  • Peking University First HospitaBeijing, ChinaNo longer taking part

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Trial details

Who runs it
Peking University First Hospital
Trial code
NCT07912801
Record updated
6 November 2026
Original description
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. The investigators 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.Read full original descriptionShow less

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

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. The investigators 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.

Inclusion: Age ≥45 years; Scheduled for off-pump coronary artery bypass grafting (CABG); Preoperative anemia, defined as hemoglobin <130 g/L in men or <120 g/L in women.

Exclusion: Current erythropoietin therapy; Diagnosis of cancer; Preoperative myocardial injury with high-sensitivity cardiac troponin I (hs-cTnI) still rising or not yet decreased to <10 times the upper reference limit; Severe hepatic impairment (Child-Pugh class C); Stage 5 chronic kidney disease requiring dialysis before surgery; Known allergy or hypersensitivity to roxadustat; Any other condition that, in the judgment of the investigator or treating physician, would make participation inappropriate; ASA physical status > IV.

ClinicalTrials.gov NCT07912801