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

Shanghai Jiao Tong University

Status and phase

Unknown

Phase 2

Conditions

ST Elevation Myocardial Infarction

Treatments

Drug: Roxadustat

Study type

Interventional

Funder types

Other

Identifiers

NCT04803864

SHDC2020CR2023B

Details and patient eligibility

About

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.

Full 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.

Enrollment

158 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.)