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

August 31, 2021 updated by: RUIYAN ZHANG, Ruijin Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

158

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital
        • Contact:
        • Sub-Investigator:
          • Xiaoxiang Yan, M.D., Ph.D.
        • Sub-Investigator:
          • Tianqi Zhu, M.D.
        • Sub-Investigator:
          • Run Du, M.D.
        • Sub-Investigator:
          • Shuo Feng, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Roxadustat
Early and short-term Roxadustat treatment
Drug: Roxadustat
Orally 100mg, 3 times per week for 2 weeks First dose administered immediately after successful PCI.
Other Names:
  • Evrenzo
No Intervention: Control
Patients only receive conventional therapies as recommended by guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: 0 - 1 year
Major adverse cardiovascular events (MACE) within 1 year follow-up.
0 - 1 year
Left Ventricular Function
Time Frame: 1 month, 6 months, 1 year
Left ventricular end diastolic volume (LVEDV), Left ventricular end systolic volume (LVESV), Left ventricular ejection fraction (LVEF) changes during 1 year follow-up
1 month, 6 months, 1 year
Cardiac enzymes - peak concentration
Time Frame: 0 - 3 days
Peak Plasma Concentration (Cmax) of CK-MB, TnI and CK
0 - 3 days
Cardiac enzymes - Area under curve
Time Frame: 0 - 3 days
Area under the plasma concentration versus time curve (AUC) of CK-MB, TnI and CK
0 - 3 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial fibrosis
Time Frame: 30 days
Fibroblast activation protein inhibitor (FAPI) tracer uptake in myocardium if selected patient underwent spontaneous PET/MR scan
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Investigators

  • Principal Investigator: Ruiyan Zhang, M.D., Ph.D., Ruijin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2021

Primary Completion (Anticipated)

September 30, 2022

Study Completion (Anticipated)

August 31, 2023

Study Registration Dates

First Submitted

February 2, 2021

First Submitted That Met QC Criteria

March 16, 2021

First Posted (Actual)

March 18, 2021

Study Record Updates

Last Update Posted (Actual)

September 1, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHDC2020CR2023B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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