Study of Roxadustat in the Treatment of Acute Myocardial Infarction

Last updated: August 31, 2021
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Cardiac Ischemia

Blood Clots

Myocardial Ischemia

Treatment

N/A

Clinical Study ID

NCT04803864
SHDC2020CR2023B
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofculprit 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

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 Design

Total Participants: 158
Study Start date:
June 10, 2021
Estimated Completion Date:
August 31, 2023

Study 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.

Connect with a study center

  • Ruijin Hospital

    Shanghai, Shanghai 200025
    China

    Active - Recruiting

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