ST Elevation Myocardial InfarctionPhase 2ROXAMINCT04803864
Study of Roxadustat in the Treatment of Acute Myocardial Infarction
A Phase 2 study testing Roxadustat in people with ST Elevation Myocardial Infarction, run by Ruijin Hospital at 1 site in China.
Trial summary
Depite successful primary percutaneous coronary intervention (PCI) and standardized medical treatment, prognosis of acute ST-elevation myocardial infarction patents are still a poor, with high morality and various complications such as heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction
- What is being tested?
- Roxadustat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2021to 31 Aug 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute STEMI (ST segment elevation myocardial infarction) diagnosed by ST elevation
- Coronary angiography within 12 hours of symptom onset, with TIMI flow grade 0 - 1 of culprit vessel
- Primary PCI with TIMI flow grade 2 - 3 after successful intervention
- Capable and willing to provide informed consent and capable of completing study visits
Who cannot join
- Previous acute myocardial infarction history
- Cardiogenic Shock at admission
- Previously treated by roxadustat
- Contraindications of roxadustat treatment
- Contraindication of Cardiac MRI (e.g. eGFR < 30 ml/min, pacemaker, metal prosthesis, etc.)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Shuo Feng, M.D., +86 15921388296, fengshuorv@hotmail.com
Xiaoxiang Yan, M.D., Ph.D.
About this study
Official title: A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Roxadustat in Patients With Acute ST Elevation Myocardial Infarction
Depite successful primary percutaneous coronary intervention (PCI) and standardized medical treatment, prognosis of acute ST-elevation myocardial infarction patents are still a poor, with high morality and various complications such as heart failure. Roxadustat is a new drug targeting hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibition and has shown promising effect in reducing infarct size in pre-clinical studies.
This study aims to evaluate the efficacy and safety of early and short-term administration of roxadustat in the treatment of acute ST-elevation myocardial infarction.
Read the detailed description
This study is an open-label, paralleled, randomized controlled trial. It aims to evaluate the efficacy and safety of early and short-term administration of roxadustat in the treatment of acute ST-elevation myocardial infarction.
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- Roxadustat
- Keywords
- ST Elevation Myocardial Infarction, Roxadustat, Infarct Size, Cardiac MRI
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoxadustatDrug
Also called Evrenzo
Orally 100mg, 3 times per week for 2 weeks First dose administered immediately after successful PCI.
| Study group | Role | What they receive |
|---|---|---|
| Roxadustat | Experimental | Early and short-term Roxadustat treatment Receives: Drug: Roxadustat |
| Control | No intervention | Patients only receive conventional therapies as recommended by guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct Size
Infarct size as a percentage of LV mass measured on delayed-enhanced CMR imaging 30 days post-MI compared to control
Measured: 30 days
Secondary outcomes (4)
MACE
Major adverse cardiovascular events (MACE) within 1 year follow-up.
Measured: 0 - 1 year
Left Ventricular Function
Left ventricular end diastolic volume (LVEDV), Left ventricular end systolic volume (LVESV), Left ventricular ejection fraction (LVEF) changes during 1 year follow-up
Measured: 1 month, 6 months, 1 year
Cardiac enzymes - peak concentration
Peak Plasma Concentration (Cmax) of CK-MB, TnI and CK
Measured: 0 - 3 days
Cardiac enzymes - Area under curve
Area under the plasma concentration versus time curve (AUC) of CK-MB, TnI and CK
Measured: 0 - 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start10 Jun 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Ruijin 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RUIYAN ZHANG, Ruijin Hospital
- Investigators
- Ruiyan Zhang, M.D., Ph.D., Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803864
- Sponsor's protocol ID
- SHDC2020CR2023B
- Acronym
- ROXAMI
- Status last verified
- Aug 2021
- First submitted
- 2 Feb 2021
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data by contacting principle investigator of this study. Requests for IPD will be recieved, but this does not mean all requests will be shared by the investigators.
Publications
Howell NJ, Tennant DA. The role of HIFs in ischemia-reperfusion injury. Hypoxia (Auckl). 2014 Jul 30;2:107-115. doi: 10.2147/HP.S49720. eCollection 2014.
PubMed 27774470Sousa Fialho MDL, Abd Jamil AH, Stannard GA, Heather LC. Hypoxia-inducible factor 1 signalling, metabolism and its therapeutic potential in cardiovascular disease. Biochim Biophys Acta Mol Basis Dis. 2019 Apr 1;1865(4):831-843. doi: 10.1016/j.bbadis.2018.09.024. Epub 2018 Sep 25.
PubMed 30266651Schreiber T, Salhofer L, Quinting T, Fandrey J. Things get broken: the hypoxia-inducible factor prolyl hydroxylases in ischemic heart disease. Basic Res Cardiol. 2019 Mar 11;114(3):16. doi: 10.1007/s00395-019-0725-2.
PubMed 30859331Chen N, Hao C, Peng X, Lin H, Yin A, Hao L, Tao Y, Liang X, Liu Z, Xing C, Chen J, Luo L, Zuo L, Liao Y, Liu BC, Leong R, Wang C, Liu C, Neff T, Szczech L, Yu KP. Roxadustat for Anemia in Patients with Kidney Disease Not Receiving Dialysis. N Engl J Med. 2019 Sep 12;381(11):1001-1010. doi: 10.1056/NEJMoa1813599. Epub 2019 Jul 24.
PubMed 31340089Deguchi H, Ikeda M, Ide T, Tadokoro T, Ikeda S, Okabe K, Ishikita A, Saku K, Matsushima S, Tsutsui H. Roxadustat Markedly Reduces Myocardial Ischemia Reperfusion Injury in Mice. Circ J. 2020 May 25;84(6):1028-1033. doi: 10.1253/circj.CJ-19-1039. Epub 2020 Mar 24.
PubMed 32213720Groenendaal-van de Meent D, den Adel M, Rijnders S, Krebs-Brown A, Kerbusch V, Golor G, Schaddelee M. The Hypoxia-inducible Factor Prolyl-Hydroxylase Inhibitor Roxadustat (FG-4592) and Warfarin in Healthy Volunteers: A Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction Study. Clin Ther. 2016 Apr;38(4):918-28. doi: 10.1016/j.clinthera.2016.02.010. Epub 2016 Mar 4.
PubMed 26947173Quan W, Wang Y, Zhang M, Zhu T, Zhu J, Wang X, Zhu Z, Du R, Ding F, Ni J, Feng S, Xie H, Liu L, Fang Y, Qu X, Zhang R, Yan X. Roxadustat Treatment After PCI Among Patients With ST-Segment Elevation Myocardial Infarction: A Randomized Clinical Trial. JAMA Netw Open. 2026 Oct 1;9(10):e2637953. doi: 10.1001/jamanetworkopen.2026.37953.
PubMed 42853570
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Roxadustat in Patients With Acute ST Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT04803864
- Acronym / sponsor ID
- ROXAMI / SHDC2020CR2023B
- Conditions
- ST Elevation Myocardial Infarction
- Keywords
- ST Elevation Myocardial Infarction, Roxadustat, Infarct Size, Cardiac MRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 18 Mar 2021 (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.
Depite successful primary percutaneous coronary intervention (PCI) and standardized medical treatment, prognosis of acute ST-elevation myocardial infarction patents are still a poor, with high morality and various complications such as heart failure. Roxadustat is a new drug targeting hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibition and has shown promising effect in reducing infarct size in pre-clinical studies.
This study aims to evaluate the efficacy and safety of early and short-term administration of roxadustat in the treatment of acute ST-elevation myocardial infarction.
Detailed description
This study is an open-label, paralleled, randomized controlled trial. It aims to evaluate the efficacy and safety of early and short-term administration of roxadustat in the treatment of acute ST-elevation myocardial infarction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roxadustat | Experimental | Drug: RoxadustatEarly and short-term Roxadustat treatment |
| Control | No intervention | –Patients only receive conventional therapies as recommended by guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Acute STEMI (ST segment elevation myocardial infarction) diagnosed by ST elevation
- Coronary angiography within 12 hours of symptom onset, with TIMI flow grade 0 - 1 of culprit vessel
- Primary PCI with TIMI flow grade 2 - 3 after successful intervention
- Capable and willing to provide informed consent and capable of completing study visits
Key exclusion criteria (5 listed)
- Previous acute myocardial infarction history
- Cardiogenic Shock at admission
- Previously treated by roxadustat
- Contraindications of roxadustat treatment
- Contraindication of Cardiac MRI (e.g. eGFR < 30 ml/min, pacemaker, metal prosthesis, etc.)
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: EvrenzoOrally 100mg, 3 times per week for 2 weeks First dose administered immediately after successful PCI. | Drug | Roxadustat |
Primary outcome
Infarct Size
Time frame: 30 days
Infarct size as a percentage of LV mass measured on delayed-enhanced CMR imaging 30 days post-MI compared to control
4 secondary outcomes
MACE
Time frame: 0 - 1 year
Left Ventricular Function
Time frame: 1 month, 6 months, 1 year
Cardiac enzymes - peak concentration
Time frame: 0 - 3 days
Cardiac enzymes - Area under curve
Time frame: 0 - 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Background: PubMed 27774470Howell NJ, Tennant DA. The role of HIFs in ischemia-reperfusion injury. Hypoxia (Auckl). 2014 Jul 30;2:107-115. doi: 10.2147/HP.S49720. eCollection 2014.
- Background: PubMed 30266651Sousa Fialho MDL, Abd Jamil AH, Stannard GA, Heather LC. Hypoxia-inducible factor 1 signalling, metabolism and its therapeutic potential in cardiovascular disease. Biochim Biophys Acta Mol Basis Dis. 2019 Apr 1;1865(4):831-843. doi: 10.1016/j.bbadis.2018.09.024. Epub 2018 Sep 25.
- Background: PubMed 30859331Schreiber T, Salhofer L, Quinting T, Fandrey J. Things get broken: the hypoxia-inducible factor prolyl hydroxylases in ischemic heart disease. Basic Res Cardiol. 2019 Mar 11;114(3):16. doi: 10.1007/s00395-019-0725-2.
- Background: PubMed 31340089Chen N, Hao C, Peng X, Lin H, Yin A, Hao L, Tao Y, Liang X, Liu Z, Xing C, Chen J, Luo L, Zuo L, Liao Y, Liu BC, Leong R, Wang C, Liu C, Neff T, Szczech L, Yu KP. Roxadustat for Anemia in Patients with Kidney Disease Not Receiving Dialysis. N Engl J Med. 2019 Sep 12;381(11):1001-1010. doi: 10.1056/NEJMoa1813599. Epub 2019 Jul 24.
- Background: PubMed 32213720Deguchi H, Ikeda M, Ide T, Tadokoro T, Ikeda S, Okabe K, Ishikita A, Saku K, Matsushima S, Tsutsui H. Roxadustat Markedly Reduces Myocardial Ischemia Reperfusion Injury in Mice. Circ J. 2020 May 25;84(6):1028-1033. doi: 10.1253/circj.CJ-19-1039. Epub 2020 Mar 24.
- Background: PubMed 26947173Groenendaal-van de Meent D, den Adel M, Rijnders S, Krebs-Brown A, Kerbusch V, Golor G, Schaddelee M. The Hypoxia-inducible Factor Prolyl-Hydroxylase Inhibitor Roxadustat (FG-4592) and Warfarin in Healthy Volunteers: A Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction Study. Clin Ther. 2016 Apr;38(4):918-28. doi: 10.1016/j.clinthera.2016.02.010. Epub 2016 Mar 4.
- Derived from this study: PubMed 42853570Quan W, Wang Y, Zhang M, Zhu T, Zhu J, Wang X, Zhu Z, Du R, Ding F, Ni J, Feng S, Xie H, Liu L, Fang Y, Qu X, Zhang R, Yan X. Roxadustat Treatment After PCI Among Patients With ST-Segment Elevation Myocardial Infarction: A Randomized Clinical Trial. JAMA Netw Open. 2026 Oct 1;9(10):e2637953. doi: 10.1001/jamanetworkopen.2026.37953.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data by contacting principle investigator of this study. Requests for IPD will be recieved, but this does not mean all requests will be shared by the investigators.
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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. This study is not recruiting at the moment.
Ruiyan Zhang, M.D., Ph.D. principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Roxadustat in people with ST Elevation Myocardial Infarction, run by Ruijin 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Sep 2021. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuo Feng, M.D. (+86 15921388296, fengshuorv@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infarct Size (time frame: 30 days). 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 NCT04803864, which also lists 7 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 1 Sep 2021.