Open-label Study of Neuraminidase Inhibitor Treatment in STEMI Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: ST Elevation Myocardial Infarction; STEMI
• Intervention / Treatment: Drug: Oseltamivir phosphate capsules

• Study Type: Interventional
• Enrollment (Anticipated): 382
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Luyun Wang, M.D., Ph.D; Phone Number: +86-02783665548; Email: wangluyun2004@126.com
• Study Contact Backup: Name: Jiangang Jiang, M.D., Ph.D; Phone Number: +86-02783665548; Email: jiangjg618@126.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Luyun Wang, M.D., Ph.D.; Phone Number: +86-02783665548; Email: wangluyun2004@126.com
      • Contact: Jiangang Jiang, M.D., Ph.D.; Phone Number: +86-02783665548; Email: jiangjg618@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tamiflu (Oseltamivir Phosphate Capsules); Standardized STEMI treatment + oseltamivir phosphate capsule (75mg, 2 times/day, 7days, oral)	Drug: Oseltamivir phosphate capsules; Treatment group vs. Control group; Other Names: Tamiflu
Other: no intervention; Standardized STEMI treatment + no intervention	Drug: Oseltamivir phosphate capsules; Treatment group vs. Control group; Other Names: Tamiflu

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial infarct size at 1 week	Myocardial infarct size at 1 week after acute myocardial infarction (quantified by Gadolinium-enhanced MRI).	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial infarct size	Myocardial infarct size under the curve of creatine kinase-MB (CK-MB) and hypersensitive troponin I.	1 week
Myocardial infarct size based on culprit vessel with TIMI 0-1 blood flow	Evaluated by coronary angiography and CMR.	1 week
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
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
Myocardial infarct size at 3 month	Myocardial infarct size at 3 month after acute myocardial infarction (quantified by Gadolinium-enhanced MRI).	3 month
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

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Investigators: Principal Investigator: Dao Wen Wang, M.D., Ph.D, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): March 31, 2024

Study Registration Dates

• First Submitted: December 21, 2020
• First Submitted That Met QC Criteria: December 23, 2020
• First Posted (Actual): December 24, 2020

Study Record Updates

• Last Update Posted (Actual): December 24, 2020
• Last Update Submitted That Met QC Criteria: December 23, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Oseltamivir
• Other Study ID Numbers: TJ-AMI-NI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No