Open-label Study of Neuraminidase Inhibitor Treatment in STEMI Patients

STEMI Clinical Trial

Official title:

An Open-label Study to Evaluate the Efficacy of Neuraminidase Inhibitor Treatment in ST-Elevation Myocardial Infarction (STEMI) Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04684498
• Other study ID #: TJ-AMI-NI
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2020
• Est. completion date: March 31, 2024

Study information

• Verified date: December 2020
• Source: Tongji Hospital
• Contact: Luyun Wang, M.D., Ph.D
• Phone: +86-02783665548
• Email: wangluyun2004[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 382
• Est. completion date: March 31, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• STEMI

Intervention

Drug:
• Oseltamivir phosphate capsules
Treatment group vs. Control group

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial infarct size at 1 week	Myocardial infarct size at 1 week after acute myocardial infarction (quantified by Gadolinium-enhanced MRI).	1 week
Secondary	Myocardial infarct size	Myocardial infarct size under the curve of creatine kinase-MB (CK-MB) and hypersensitive troponin I.	1 week
Secondary	Myocardial infarct size based on culprit vessel with TIMI 0-1 blood flow	Evaluated by coronary angiography and CMR.	1 week
Secondary	The proportion of viable myocardium and ratio of myocardial reperfusion	The proportion of viable myocardium and reperfusion was determined by the range of abnormal enhancement of gadolinium.	1 week
Secondary	Composite end point at 1 week	A composite end point of cardiogenic shock, cardiac death, malignant arrhythmia, and resuscitated cardiac arrest (including ventricular fibrillation) at 1 week.	1 week
Secondary	Myocardial infarct size at 3 month	Myocardial infarct size at 3 month after acute myocardial infarction (quantified by Gadolinium-enhanced MRI).	3 month
Secondary	Composite end point at 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.	6 month