A Phase 4 interventional study of Roxadustat and Placebo in Coronary Artery Disease, Coronary Artery Bypass Grafting and Hypoxia-Inducible Factor 1, Alpha Subunit, sponsored by Peking University First Hospital. Not yet recruiting at 1 site in China. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Peking University First Hospital · Phase 4, Interventional, and Prevention
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.
Myocardial injury and infarction, usually of myocardial ischemic origin, are common in patients after cardiac surgery and are associated with worse perioperative outcomes, including arrhythmia, heart failure, and even death.
Hypoxia-inducible factor (HIF) is an important regulator of metabolism that protects the myocardium. Specifically, HIF-1α is activated during acute myocardial ischemia and in turn enhances anaerobic metabolism and increases myocardial ATP production; HIF-1α also inhibits aerobic metabolism and the generation of reactive oxygen species (ROS). These effects alleviate myocardial ischemia-reperfusion injury.
Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). It enhances the hypoxia-protective pathway and erythropoiesis and is approved for the treatment of anemia of chronic kidney disease. Available studies suggest that, in patients with chronic kidney disease-related anemia, roxadustat increases hemoglobin and tends to reduce the risk of major adverse cardiovascular events (MACE).
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 data regarding the potential effect of roxadustat on the occurrence of myocardial injury or infarction in patients undergoing off-pump CABG.
5,683 studies on the registry are indexed under Coronary Artery Disease; 960 are open to participants now.
This study's planned enrollment of 80 is below the median of 123 across 3,487 interventional studies indexed under Coronary Artery Disease.
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Exclusion Criteria:
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: Roxadustat
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.
Drug: Placebo
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.
Also known as: Oral roxadustat
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.
Also known as: Oral placebo
Proportion of participants completing the trial intervention
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.
Time frame: Up to 30 days postoperatively.
Recruitment rate
Recruitment rate is defined as the proportion of eligible patients who provide written informed consent and undergo randomization.
Time frame: Screening and randomization period (before trial intervention).
Peak hs-cTnI within 72 hours after surgery
Peak serum high-sensitivity cardiac troponin I (hs-cTnI) concentration within 72 hours after surgery
Time frame: Up to 72 hours after surgery.
Incidence of KDIGO stage 2 or 3 acute kidney injury within 7 days after surgery
Stage 2 or 3 acute kidney injury will be diagnosed according to the KDIGO (Kidney Disease: Improving Global Outcomes) serum creatinine criteria.
Time frame: Up to 7 days after surgery.
Incience of MACE within 30 days after surgery
Major adverse cardiac events (MACE) are defined as a composite of myocardial infarction, stroke, ventricular arrhythmia requiring treatment, new-onset heart failure, reoperation, and cardiovascular death.
Time frame: Up to 30 days after surgery.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.
Of 188 non-industry phase 4 interventional studies under Coronary Artery Disease, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 59. This study's planned 12 months is below that.
Counting every sponsor, half of 206 studies reached it within 36 months; a quarter within 20 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Roxadustat
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