NCT07912801Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Effect of Preoperative Roxadustat on Myocardial Injury After Off-Pump Coronary Artery Bypass Graft Surgery: A Pilot Randomized Trial
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 28 Oct 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 30 Nov 2027
- Lead sponsor
- Peking University First Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT07912801
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 80
- From 1 Nov 2026 to the primary completion date, 30 Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current erythropoietin therapy.
Other illness
- 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.
Other
- ASA physical status \> IV.
Who the study is looking for
- 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.
Age in the registry: 45 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University First Hospita Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.