Coronary Artery DiseasePhase 4NCT07912801
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
A Phase 4 study testing Roxadustat in people with Coronary Artery Disease and Coronary Artery Bypass Grafting, run by Peking University First Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Bypass Grafting, Hypoxia-Inducible Factor 1, Alpha Subunit
- What is being tested?
- Roxadustat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Nov 2026to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Diagnosis of cancer.
- Current erythropoietin therapy.
- 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.
- ASA physical status > IV.
- Known allergy or hypersensitivity to roxadustat.
- Any other condition that, in the judgment of the investigator or treating physician, would make participation inappropriate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ya-Fei Liu, MD contact
China1 site
Peking University First Hospita
Beijing, Beijing Municipality, 100034
Ya-Fei Liu, MD, 86-010-83575138, liuyf_723@163.com
Ya-Fei Liu, MD
About this study
Official title: 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.
Read the detailed description
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, hypoxia-inducible factor-1α (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. 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.
The investigators hypothesize that, in patients undergoing off-pump 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.
- Conditions
- Coronary Artery Disease, Coronary Artery Bypass Grafting, Hypoxia-Inducible Factor 1, Alpha Subunit, Prolyl-Hydroxylase Inhibitors, Myocardial Ischemia, Myocardial Infarction Postoperative
- Being tested
- Roxadustat, Placebo
- Keywords
- Coronary artery isease, Off-pump coronary artery bypass grafting, Roxadustat, Myocardial injury or infarction, Postoperative complications
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Infarction, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoxadustatDrug
Also called Oral 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.
PlaceboDrug
Also called Oral 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 group | Role | What they receive |
|---|---|---|
| Roxadustat group | Experimental | 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. Receives: Drug: Roxadustat |
| Placebo group | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 the trial medication as randomized; (2) they underwent the scheduled high-sensitivity cardiac troponin I measurements during the perioperative period; and (3) they completed the 30-day postoperative follow-up.
Measured: Up to 30 days postoperatively.
Secondary outcomes (4)
Recruitment rate
Recruitment rate is defined as the proportion of eligible patients who provide written informed consent and undergo randomization.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Up to 30 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Xin Wang, Peking University First Hospital
- Investigators
- Dong-Xin Wang, MD, PhD, Principal investigator, Peking University First Hospital, Beijing, Beijing 100034
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912801
- Sponsor's protocol ID
- 2026R0523
- Status last verified
- Nov 2026
- First submitted
- 28 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Lemos JA, Jessen M. High-Sensitivity Troponin after Cardiac Surgery - Is the VISION Any Clearer? N Engl J Med. 2022 Mar 3;386(9):890-891. doi: 10.1056/NEJMe2119016. No abstract available.
PubMed 35235732Gaudino M, Flather M, Capodanno D, Milojevic M, Bhatt DL, Biondi Zoccai G, Boden WE, Devereaux PJ, Doenst T, Farkouh M, Freemantle N, Fremes S, Puskas J, Landoni G, Lawton J, Myers PO, Redfors B, Sandner S. European Association of Cardio-Thoracic Surgery (EACTS) expert consensus statement on perioperative myocardial infarction after cardiac surgery. Eur J Cardiothorac Surg. 2024 Feb 1;65(2):ezad415. doi: 10.1093/ejcts/ezad415.
PubMed 38420786Denessen EJ, Heuts S, Daemen JH, van Doorn WP, Vroemen WH, Sels JW, Segers P, Van't Hof AW, Maessen JG, Bekers O, Van Der Horst IC, Mingels AM. High-Sensitivity Cardiac Troponin I and T Kinetics Differ following Coronary Bypass Surgery: A Systematic Review and Meta-Analysis. Clin Chem. 2022 Dec 6;68(12):1564-1575. doi: 10.1093/clinchem/hvac152.
PubMed 36366960Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). Circulation. 2018 Nov 13;138(20):e618-e651. doi: 10.1161/CIR.0000000000000617. No abstract available.
PubMed 30571511Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018 Jun 12;137(24):2635-2650. doi: 10.1161/CIRCULATIONAHA.117.029289.
PubMed 29891620Devereaux PJ, Whitlock R, Lamy A. Perioperative Myocardial Injury/Infarction After Cardiac Surgery: The Diagnostic Criteria Need to Change. J Am Coll Cardiol. 2023 Sep 26;82(13):1313-1315. doi: 10.1016/j.jacc.2023.08.001. No abstract available.
PubMed 37730287Domanski MJ, Mahaffey K, Hasselblad V, Brener SJ, Smith PK, Hillis G, Engoren M, Alexander JH, Levy JH, Chaitman BR, Broderick S, Mack MJ, Pieper KS, Farkouh ME. Association of myocardial enzyme elevation and survival following coronary artery bypass graft surgery. JAMA. 2011 Feb 9;305(6):585-91. doi: 10.1001/jama.2011.99.
PubMed 21304084Devereaux PJ, Lamy A, Chan MTV, Allard RV, Lomivorotov VV, Landoni G, Zheng H, Paparella D, McGillion MH, Belley-Cote EP, Parlow JL, Underwood MJ, Wang CY, Dvirnik N, Abubakirov M, Fominskiy E, Choi S, Fremes S, Monaco F, Urrutia G, Maestre M, Hajjar LA, Hillis GS, Mills NL, Margari V, Mills JD, Billing JS, Methangkool E, Polanczyk CA, Sant'Anna R, Shukevich D, Conen D, Kavsak PA, McQueen MJ, Brady K, Spence J, Le Manach Y, Mian R, Lee SF, Bangdiwala SI, Hussain S, Borges FK, Pettit S, Vincent J, Guyatt GH, Yusuf S, Alpert JS, White HD, Whitlock RP; VISION Cardiac Surgery Investigators. High-Sensitivity Troponin I after Cardiac Surgery and 30-Day Mortality. N Engl J Med. 2022 Mar 3;386(9):827-836. doi: 10.1056/NEJMoa2000803.
PubMed 35235725Thio MSY, Noordzij PG, Ruven HJT, Reniers T, Ten Berg JM, Oemrawsingh RM, Langelaan MLP, Rettig TCD. Redefinition of Myocardial Infarction After Cardiac Surgery: A two-centre Clinical Evaluation of the Proposed European Association for Cardio-thoracic Surgery Algorithm for the Diagnosis of Perioperative Myocardial Injury and Infarction. Eur J Cardiothorac Surg. 2025 Jul 1;67(7):ezaf231. doi: 10.1093/ejcts/ezaf231.
PubMed 40632613Knutson AK, Williams AL, Boisvert WA, Shohet RV. HIF in the heart: development, metabolism, ischemia, and atherosclerosis. J Clin Invest. 2021 Sep 1;131(17):e137557. doi: 10.1172/JCI137557.
PubMed 34623330Wu J, Chen P, Li Y, Ardell C, Der T, Shohet R, Chen M, Wright GL. HIF-1alpha in heart: protective mechanisms. Am J Physiol Heart Circ Physiol. 2013 Sep 15;305(6):H821-8. doi: 10.1152/ajpheart.00140.2013. Epub 2013 Jul 19.
PubMed 23873797Bishop T, Ratcliffe PJ. HIF hydroxylase pathways in cardiovascular physiology and medicine. Circ Res. 2015 Jun 19;117(1):65-79. doi: 10.1161/CIRCRESAHA.117.305109.
PubMed 26089364Donato M, Evelson P, Gelpi RJ. Protecting the heart from ischemia/reperfusion injury: an update on remote ischemic preconditioning and postconditioning. Curr Opin Cardiol. 2017 Nov;32(6):784-790. doi: 10.1097/HCO.0000000000000447.
PubMed 28902715Serocki M, Bartoszewska S, Janaszak-Jasiecka A, Ochocka RJ, Collawn JF, Bartoszewski R. miRNAs regulate the HIF switch during hypoxia: a novel therapeutic target. Angiogenesis. 2018 May;21(2):183-202. doi: 10.1007/s10456-018-9600-2. Epub 2018 Jan 27.
PubMed 29383635Koeppen M, Lee JW, Seo SW, Brodsky KS, Kreth S, Yang IV, Buttrick PM, Eckle T, Eltzschig HK. Hypoxia-inducible factor 2-alpha-dependent induction of amphiregulin dampens myocardial ischemia-reperfusion injury. Nat Commun. 2018 Feb 26;9(1):816. doi: 10.1038/s41467-018-03105-2.
PubMed 29483579
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Roxadustat on Myocardial Injury After Off-Pump Coronary Artery Bypass Graft Surgery: A Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT07912801
- Acronym / sponsor ID
- 2026R0523
- Conditions
- Coronary Artery Disease, Coronary Artery Bypass Grafting, Hypoxia-Inducible Factor 1, Alpha Subunit, Prolyl-Hydroxylase Inhibitors, Myocardial Ischemia, Myocardial Infarction Postoperative
- Keywords
- Coronary artery isease, Off-pump coronary artery bypass grafting, Roxadustat, Myocardial injury or infarction, Postoperative complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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, hypoxia-inducible factor-1α (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. 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.
The investigators hypothesize that, in patients undergoing off-pump 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roxadustat group | Experimental | Drug: RoxadustatParticipants 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 group | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- Diagnosis of cancer.
- Current erythropoietin therapy.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RoxadustatAlso: Oral roxadustatParticipants 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 group |
| PlaceboAlso: Oral placeboParticipants 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 group |
Primary outcome
Proportion of participants completing the trial intervention
Time frame: 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 the trial medication as randomized; (2) they underwent the scheduled high-sensitivity cardiac troponin I measurements during the perioperative period; and (3) they completed the 30-day postoperative follow-up.
4 secondary outcomes
Recruitment rate
Time frame: Screening and randomization period (before trial intervention).
Peak hs-cTnI 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
Time frame: Up to 7 days after surgery.
Incience of MACE within 30 days after surgery
Time frame: Up to 30 days after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 35235732de Lemos JA, Jessen M. High-Sensitivity Troponin after Cardiac Surgery - Is the VISION Any Clearer? N Engl J Med. 2022 Mar 3;386(9):890-891. doi: 10.1056/NEJMe2119016. No abstract available.
- Background: PubMed 38420786Gaudino M, Flather M, Capodanno D, Milojevic M, Bhatt DL, Biondi Zoccai G, Boden WE, Devereaux PJ, Doenst T, Farkouh M, Freemantle N, Fremes S, Puskas J, Landoni G, Lawton J, Myers PO, Redfors B, Sandner S. European Association of Cardio-Thoracic Surgery (EACTS) expert consensus statement on perioperative myocardial infarction after cardiac surgery. Eur J Cardiothorac Surg. 2024 Feb 1;65(2):ezad415. doi: 10.1093/ejcts/ezad415.
- Background: PubMed 36366960Denessen EJ, Heuts S, Daemen JH, van Doorn WP, Vroemen WH, Sels JW, Segers P, Van't Hof AW, Maessen JG, Bekers O, Van Der Horst IC, Mingels AM. High-Sensitivity Cardiac Troponin I and T Kinetics Differ following Coronary Bypass Surgery: A Systematic Review and Meta-Analysis. Clin Chem. 2022 Dec 6;68(12):1564-1575. doi: 10.1093/clinchem/hvac152.
- Background: PubMed 30571511Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). Circulation. 2018 Nov 13;138(20):e618-e651. doi: 10.1161/CIR.0000000000000617. No abstract available.
- Background: PubMed 29891620Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018 Jun 12;137(24):2635-2650. doi: 10.1161/CIRCULATIONAHA.117.029289.
- Background: PubMed 37730287Devereaux PJ, Whitlock R, Lamy A. Perioperative Myocardial Injury/Infarction After Cardiac Surgery: The Diagnostic Criteria Need to Change. J Am Coll Cardiol. 2023 Sep 26;82(13):1313-1315. doi: 10.1016/j.jacc.2023.08.001. No abstract available.
- Background: PubMed 21304084Domanski MJ, Mahaffey K, Hasselblad V, Brener SJ, Smith PK, Hillis G, Engoren M, Alexander JH, Levy JH, Chaitman BR, Broderick S, Mack MJ, Pieper KS, Farkouh ME. Association of myocardial enzyme elevation and survival following coronary artery bypass graft surgery. JAMA. 2011 Feb 9;305(6):585-91. doi: 10.1001/jama.2011.99.
- Background: PubMed 35235725Devereaux PJ, Lamy A, Chan MTV, Allard RV, Lomivorotov VV, Landoni G, Zheng H, Paparella D, McGillion MH, Belley-Cote EP, Parlow JL, Underwood MJ, Wang CY, Dvirnik N, Abubakirov M, Fominskiy E, Choi S, Fremes S, Monaco F, Urrutia G, Maestre M, Hajjar LA, Hillis GS, Mills NL, Margari V, Mills JD, Billing JS, Methangkool E, Polanczyk CA, Sant'Anna R, Shukevich D, Conen D, Kavsak PA, McQueen MJ, Brady K, Spence J, Le Manach Y, Mian R, Lee SF, Bangdiwala SI, Hussain S, Borges FK, Pettit S, Vincent J, Guyatt GH, Yusuf S, Alpert JS, White HD, Whitlock RP; VISION Cardiac Surgery Investigators. High-Sensitivity Troponin I after Cardiac Surgery and 30-Day Mortality. N Engl J Med. 2022 Mar 3;386(9):827-836. doi: 10.1056/NEJMoa2000803.
- Background: PubMed 40632613Thio MSY, Noordzij PG, Ruven HJT, Reniers T, Ten Berg JM, Oemrawsingh RM, Langelaan MLP, Rettig TCD. Redefinition of Myocardial Infarction After Cardiac Surgery: A two-centre Clinical Evaluation of the Proposed European Association for Cardio-thoracic Surgery Algorithm for the Diagnosis of Perioperative Myocardial Injury and Infarction. Eur J Cardiothorac Surg. 2025 Jul 1;67(7):ezaf231. doi: 10.1093/ejcts/ezaf231.
- Background: PubMed 34623330Knutson AK, Williams AL, Boisvert WA, Shohet RV. HIF in the heart: development, metabolism, ischemia, and atherosclerosis. J Clin Invest. 2021 Sep 1;131(17):e137557. doi: 10.1172/JCI137557.
- Background: PubMed 23873797Wu J, Chen P, Li Y, Ardell C, Der T, Shohet R, Chen M, Wright GL. HIF-1alpha in heart: protective mechanisms. Am J Physiol Heart Circ Physiol. 2013 Sep 15;305(6):H821-8. doi: 10.1152/ajpheart.00140.2013. Epub 2013 Jul 19.
- Background: PubMed 26089364Bishop T, Ratcliffe PJ. HIF hydroxylase pathways in cardiovascular physiology and medicine. Circ Res. 2015 Jun 19;117(1):65-79. doi: 10.1161/CIRCRESAHA.117.305109.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ya-Fei Liu, MD contact
Dong-Xin Wang, MD, PhD principal investigator
Peking University First Hospital, Beijing, Beijing 100034
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Roxadustat in people with Coronary Artery Disease and Coronary Artery Bypass Grafting, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dong-Xin Wang, MD, PhD (86-10-83572784, wangdongxin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants completing the trial intervention (time frame: Up to 30 days postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07912801, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.