ST Elevation Myocardial Infarction
Conditions
Keywords
ST Elevation Myocardial Infarction, Roxadustat, Infarct Size, Cardiac MRI
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.
Interventions
DRUGRoxadustat
Orally 100mg, 3 times per week for 2 weeks First dose administered immediately after successful PCI.
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infarct Size | 30 days | Infarct size as a percentage of LV mass measured on delayed-enhanced CMR imaging 30 days post-MI compared to control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MACE | 0 - 1 year | Major adverse cardiovascular events (MACE) within 1 year follow-up. |
| Left Ventricular Function | 1 month, 6 months, 1 year | Left ventricular end diastolic volume (LVEDV), Left ventricular end systolic volume (LVESV), Left ventricular ejection fraction (LVEF) changes during 1 year follow-up |
| Cardiac enzymes - peak concentration | 0 - 3 days | Peak Plasma Concentration (Cmax) of CK-MB, TnI and CK |
| Cardiac enzymes - Area under curve | 0 - 3 days | Area under the plasma concentration versus time curve (AUC) of CK-MB, TnI and CK |
Other
| Measure | Time frame | Description |
|---|---|---|
| Myocardial fibrosis | 30 days | Fibroblast activation protein inhibitor (FAPI) tracer uptake in myocardium if selected patient underwent spontaneous PET/MR scan |
Countries
China
Contacts
Primary ContactShuo Feng, M.D.
Outcome results
None listed