Study of Roxadustat in the Treatment of Acute Myocardial Infarction

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Roxadustat in Patients With Acute ST Elevation Myocardial Infarction

Conditions
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ST Elevation Myocardial Infarction

Intervention / Treatment
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* Drug: Roxadustat


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct Size | 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 | Major adverse cardiovascular events (MACE) within 1 year follow-up. | 0 - 1 year | 
| Left Ventricular Function | 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 | Peak Plasma Concentration (Cmax) of CK-MB, TnI and CK | 0 - 3 days | 
| Cardiac enzymes - Area under curve | Area under the plasma concentration versus time curve (AUC) of CK-MB, TnI and CK | 0 - 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ST Elevation Myocardial Infarction, Roxadustat, Infarct Size, Cardiac MRI