Open-label Study of Neuraminidase Inhibitor Treatment in STEMI Patients
- Conditions
- STEMIST Elevation Myocardial Infarction
- Interventions
- Registration Number
- NCT04684498
- Lead Sponsor
- Tongji Hospital
- Brief Summary
Neuraminidase-1 can cause the removal of terminal sialic acid residues from the cell surface or serum sialyloconjugates. The level of Neu5Ac was positively related to the activity of neuraminidase-1. Elevation of Neu5Ac was observed in myocardial ischemia animal model, as well as patients with coronary artery disease. It is interesting to note that Neu5Ac and its regulatory enzyme neuraminidase-1 seem to play a key role in triggering myocardial ischemic injury. Oseltamivir, a structural mimic of sialic acid, was widely used as anti-influenza drug. It suppressed neuraminidase-1 activity in the heart. Targeting neuraminidase-1 may represent a new therapeutic intervention for coronary artery disease. This project seeks to identify whether neuraminidase inhibitor (Oseltamivir) treatment could decrease the myocardial infarct size in STEMI patients and improve clinical outcomes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 382
- Between the ages of 18 and 75, regardless of gender;
- STEMI should be diagnosed by two attending physicians or above, including history, clinical symptoms and signs;
- Participate voluntarily and sign informed consent, and can be followed up for more than one month.
- Allergic to oseltamivir;
- Creatinine clearance rate less than 60%;
- Severe liver insufficiency;
- Female patients who have or plan to become pregnant;
- Life expectancy less than one year;
- Patients refused to comply with the requirements of this study;
- According to the discretion of investigator, the patient was unable to complete the study or comply with the requirements of the study (for administrative or other reasons).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tamiflu (Oseltamivir Phosphate Capsules) Oseltamivir phosphate capsules Standardized STEMI treatment + oseltamivir phosphate capsule (75mg, 2 times/day, 7days, oral) no intervention Oseltamivir phosphate capsules Standardized STEMI treatment + no intervention
- Primary Outcome Measures
Name Time Method Myocardial infarct size at 1 week 1 week Myocardial infarct size at 1 week after acute myocardial infarction (quantified by Gadolinium-enhanced MRI).
- Secondary Outcome Measures
Name Time Method Myocardial infarct size based on culprit vessel with TIMI 0-1 blood flow 1 week Evaluated by coronary angiography and CMR.
Myocardial infarct size 1 week Myocardial infarct size under the curve of creatine kinase-MB (CK-MB) and hypersensitive troponin I.
The proportion of viable myocardium and ratio of myocardial reperfusion 1 week The proportion of viable myocardium and reperfusion was determined by the range of abnormal enhancement of gadolinium.
Composite end point at 1 week 1 week A composite end point of cardiogenic shock, cardiac death, malignant arrhythmia, and resuscitated cardiac arrest (including ventricular fibrillation) at 1 week.
Myocardial infarct size at 3 month 3 month Myocardial infarct size at 3 month after acute myocardial infarction (quantified by Gadolinium-enhanced MRI).
Composite end point at 6 month 6 month Composite end point at 6 month, including all-cause death, reinfarction, heart failure after myocardial infarction, and rehospitalization of unstable angina at 6 month.
Trial Locations
- Locations (1)
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China