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ROXAMI: Study of Roxadustat in the Treatment of Acute Myocardial Infarction

Sponsor
Ruijin Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04803864
Collaborator
(none)
158
Enrollment
1
Location
2
Arms
26.7
Anticipated Duration (Months)
5.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
158 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Roxadustat in Patients With Acute ST Elevation Myocardial Infarction
Actual Study Start Date :
Jun 10, 2021
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Infarct Size [30 days]

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

    Secondary Outcome Measures

    1. MACE [0 - 1 year]

      Major adverse cardiovascular events (MACE) within 1 year follow-up.

    2. Left Ventricular Function [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

    3. Cardiac enzymes - peak concentration [0 - 3 days]

      Peak Plasma Concentration (Cmax) of CK-MB, TnI and CK

    4. Cardiac enzymes - Area under curve [0 - 3 days]

      Area under the plasma concentration versus time curve (AUC) of CK-MB, TnI and CK

    Other Outcome Measures

    1. Myocardial fibrosis [30 days]

      Fibroblast activation protein inhibitor (FAPI) tracer uptake in myocardium if selected patient underwent spontaneous PET/MR scan

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ruijin Hospital Shanghai Shanghai China 200025

    Sponsors and Collaborators

    • Ruijin Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    RUIYAN ZHANG, Director of Cardiology Department, Chief Physician, Ruijin Hospital
    ClinicalTrials.gov Identifier:
    NCT04803864
    Other Study ID Numbers:
    • SHDC2020CR2023B
    First Posted:
    Mar 18, 2021
    Last Update Posted:
    Sep 1, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by RUIYAN ZHANG, Director of Cardiology Department, Chief Physician, Ruijin Hospital
    ST Elevation Myocardial Infarction
    Roxadustat
    Infarct Size
    Cardiac MRI
    Additional relevant MeSH terms:
    Myocardial Infarction
    ST Elevation Myocardial Infarction
    Infarction

    Study Results

    No Results Posted as of Sep 1, 2021