A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Roxadustat in Patients With Acute ST Elevation Myocardial Infarction
Overview
- Phase
- Phase 2
- Intervention
- Roxadustat
- Conditions
- ST Elevation Myocardial Infarction
- Sponsor
- Ruijin Hospital
- Enrollment
- 158
- Locations
- 1
- Primary Endpoint
- Infarct Size
- Last Updated
- 4 years ago
Overview
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.
Investigators
RUIYAN ZHANG
Director of Cardiology Department, Chief Physician
Ruijin Hospital
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.)
Arms & Interventions
Roxadustat
Early and short-term Roxadustat treatment
Intervention: Roxadustat
Outcomes
Primary Outcomes
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
Secondary Outcomes
- MACE(0 - 1 year)
- Cardiac enzymes - peak concentration(0 - 3 days)
- Left Ventricular Function(1 month, 6 months, 1 year)
- Cardiac enzymes - Area under curve(0 - 3 days)