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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
158
Orally 100mg, 3 times per week for 2 weeks First dose administered immediately after successful PCI.
Ruijin Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGInfarct Size
Infarct size as a percentage of LV mass measured on delayed-enhanced CMR imaging 30 days post-MI compared to control
Time frame: 30 days
MACE
Major adverse cardiovascular events (MACE) within 1 year follow-up.
Time frame: 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
Time frame: 1 month, 6 months, 1 year
Cardiac enzymes - peak concentration
Peak Plasma Concentration (Cmax) of CK-MB, TnI and CK
Time frame: 0 - 3 days
Cardiac enzymes - Area under curve
Area under the plasma concentration versus time curve (AUC) of CK-MB, TnI and CK
Time frame: 0 - 3 days
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