Study of Roxadustat in the Treatment of Acute Myocardial Infarction

NCT ID: NCT04803864

Last Updated: 2021-09-01

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-10

Study Completion Date

2023-08-31

Brief Summary

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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

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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

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ST Elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Roxadustat

Early and short-term Roxadustat treatment

Group Type EXPERIMENTAL

Roxadustat

Intervention Type DRUG

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.

Group Type NO_INTERVENTION

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.

Intervention Type DRUG

Other Intervention Names

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Evrenzo

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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RUIYAN ZHANG

Director of Cardiology Department, Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Shuo Feng, M.D.

Role: CONTACT

+86 15921388296

Facility Contacts

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Shuo Feng, M.D.

Role: primary

+86 15921388296

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.

Reference Type BACKGROUND
PMID: 27774470 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30266651 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30859331 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31340089 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32213720 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26947173 (View on PubMed)

Other Identifiers

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SHDC2020CR2023B

Identifier Type: -

Identifier Source: org_study_id

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