Open-label Study of Neuraminidase Inhibitor Treatment in STEMI Patients

Tongji Hospital

Status and phase: Unknown; Phase 4

Conditions: ST Elevation Myocardial Infarction; STEMI

Treatments: Drug: Oseltamivir phosphate capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT04684498

TJ-AMI-NI

Details and patient eligibility

About

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.

Enrollment: 382 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Between the ages of 18 and 75, regardless of gender;
2. STEMI should be diagnosed by two attending physicians or above, including history, clinical symptoms and signs;
3. Participate voluntarily and sign informed consent, and can be followed up for more than one month.

Exclusion criteria

1. Allergic to oseltamivir;
2. Creatinine clearance rate less than 60%;
3. Severe liver insufficiency;
4. Female patients who have or plan to become pregnant;
5. Life expectancy less than one year;
6. Patients refused to comply with the requirements of this study;
7. 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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382 participants in 2 patient groups

Tamiflu (Oseltamivir Phosphate Capsules)

Experimental group

Description:

Standardized STEMI treatment + oseltamivir phosphate capsule (75mg, 2 times/day, 7days, oral)

Treatment:

Drug: Oseltamivir phosphate capsules

no intervention

Other group

Description:

Standardized STEMI treatment + no intervention

Treatment:

Drug: Oseltamivir phosphate capsules