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Study of Roxadustat in the Treatment of Acute Myocardial Infarction (ROXAMI)

Primary Purpose

ST Elevation Myocardial Infarction

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Roxadustat
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Elevation Myocardial Infarction focused on measuring ST Elevation Myocardial Infarction, Roxadustat, Infarct Size, Cardiac MRI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Ruijin HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Roxadustat

Control

Arm Description

Early and short-term Roxadustat treatment

Patients only receive conventional therapies as recommended by guidelines.

Outcomes

Primary Outcome Measures

Infarct Size
Infarct size as a percentage of LV mass measured on delayed-enhanced CMR imaging 30 days post-MI compared to control

Secondary Outcome Measures

MACE
Major adverse cardiovascular events (MACE) within 1 year follow-up.
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
Cardiac enzymes - peak concentration
Peak Plasma Concentration (Cmax) of CK-MB, TnI and CK
Cardiac enzymes - Area under curve
Area under the plasma concentration versus time curve (AUC) of CK-MB, TnI and CK

Full Information

First Posted
February 2, 2021
Last Updated
August 31, 2021
Sponsor
Ruijin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04803864
Brief Title
Study of Roxadustat in the Treatment of Acute Myocardial Infarction
Acronym
ROXAMI
Official Title
A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Roxadustat in Patients With Acute ST Elevation Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Myocardial Infarction
Keywords
ST Elevation Myocardial Infarction, Roxadustat, Infarct Size, Cardiac MRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
158 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Roxadustat
Arm Type
Experimental
Arm Description
Early and short-term Roxadustat treatment
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients only receive conventional therapies as recommended by guidelines.
Intervention Type
Drug
Intervention Name(s)
Roxadustat
Other Intervention Name(s)
Evrenzo
Intervention Description
Orally 100mg, 3 times per week for 2 weeks First dose administered immediately after successful PCI.
Primary Outcome Measure Information:
Title
Infarct Size
Description
Infarct size as a percentage of LV mass measured on delayed-enhanced CMR imaging 30 days post-MI compared to control
Time Frame
30 days
Secondary Outcome Measure Information:
Title
MACE
Description
Major adverse cardiovascular events (MACE) within 1 year follow-up.
Time Frame
0 - 1 year
Title
Left Ventricular Function
Description
Left ventricular end diastolic volume (LVEDV), Left ventricular end systolic volume (LVESV), Left ventricular ejection fraction (LVEF) changes during 1 year follow-up
Time Frame
1 month, 6 months, 1 year
Title
Cardiac enzymes - peak concentration
Description
Peak Plasma Concentration (Cmax) of CK-MB, TnI and CK
Time Frame
0 - 3 days
Title
Cardiac enzymes - Area under curve
Description
Area under the plasma concentration versus time curve (AUC) of CK-MB, TnI and CK
Time Frame
0 - 3 days
Other Pre-specified Outcome Measures:
Title
Myocardial fibrosis
Description
Fibroblast activation protein inhibitor (FAPI) tracer uptake in myocardium if selected patient underwent spontaneous PET/MR scan
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuo Feng, M.D.
Phone
+86 15921388296
Email
fengshuorv@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruiyan Zhang, M.D., Ph.D.
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuo Feng, M.D.
Phone
+86 15921388296
Email
fengshuorv@hotmail.com
First Name & Middle Initial & Last Name & Degree
Xiaoxiang Yan, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Tianqi Zhu, M.D.
First Name & Middle Initial & Last Name & Degree
Run Du, M.D.
First Name & Middle Initial & Last Name & Degree
Shuo Feng, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
1 year after the end of this study
IPD Sharing Access Criteria
Please contact the investigators through email in the time frame.
Citations:
PubMed Identifier
27774470
Citation
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.
Results Reference
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PubMed Identifier
30266651
Citation
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.
Results Reference
background
PubMed Identifier
30859331
Citation
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.
Results Reference
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PubMed Identifier
31340089
Citation
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.
Results Reference
background
PubMed Identifier
32213720
Citation
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.
Results Reference
background
PubMed Identifier
26947173
Citation
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.
Results Reference
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Study of Roxadustat in the Treatment of Acute Myocardial Infarction

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