Study of Roxadustat in the Treatment of Acute Myocardial Infarction
ROXAMI
A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Roxadustat in Patients With Acute ST Elevation Myocardial Infarction
1 other identifier
interventional
158
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2021
CompletedFirst Posted
Study publicly available on registry
March 18, 2021
CompletedStudy Start
First participant enrolled
June 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2023
CompletedSeptember 1, 2021
August 1, 2021
1.3 years
February 2, 2021
August 31, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Infarct Size
Infarct size as a percentage of LV mass measured on delayed-enhanced CMR imaging 30 days post-MI compared to control
30 days
Secondary Outcomes (4)
MACE
0 - 1 year
Left Ventricular Function
1 month, 6 months, 1 year
Cardiac enzymes - peak concentration
0 - 3 days
Cardiac enzymes - Area under curve
0 - 3 days
Other Outcomes (1)
Myocardial fibrosis
30 days
Study Arms (2)
Roxadustat
EXPERIMENTALEarly and short-term Roxadustat treatment
Control
NO INTERVENTIONPatients only receive conventional therapies as recommended by guidelines.
Interventions
Orally 100mg, 3 times per week for 2 weeks First dose administered immediately after successful PCI.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
Study Sites (1)
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025, China
Related Publications (6)
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.
PMID: 27774470BACKGROUNDSousa 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.
PMID: 30266651BACKGROUNDSchreiber 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.
PMID: 30859331BACKGROUNDChen 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.
PMID: 31340089BACKGROUNDDeguchi 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.
PMID: 32213720BACKGROUNDGroenendaal-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.
PMID: 26947173BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ruiyan Zhang, M.D., Ph.D.
Ruijin Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Cardiology Department, Chief Physician
Study Record Dates
First Submitted
February 2, 2021
First Posted
March 18, 2021
Study Start
June 10, 2021
Primary Completion
September 30, 2022
Study Completion
August 31, 2023
Last Updated
September 1, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 1 year after the end of this study
- Access Criteria
- Please contact the investigators through email in the time frame.
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.