Study of Roxadustat in the Treatment of Acute Myocardial Infarction
NCT ID: NCT04803864
Last Updated: 2021-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
158 participants
INTERVENTIONAL
2021-06-10
2023-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Roxadustat
Early and short-term Roxadustat treatment
Roxadustat
Orally 100mg, 3 times per week for 2 weeks First dose administered immediately after successful PCI.
Control
Patients only receive conventional therapies as recommended by guidelines.
No interventions assigned to this group
Interventions
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Roxadustat
Orally 100mg, 3 times per week for 2 weeks First dose administered immediately after successful PCI.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.)
18 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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RUIYAN ZHANG
Director of Cardiology Department, Chief Physician
Principal Investigators
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Ruiyan Zhang, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Locations
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Ruijin Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Sousa 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.
Schreiber 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.
Chen 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.
Deguchi 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.
Groenendaal-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.
Other Identifiers
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SHDC2020CR2023B
Identifier Type: -
Identifier Source: org_study_id
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