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
1 other identifier
interventional
382
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2020
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2020
CompletedFirst Submitted
Initial submission to the registry
December 21, 2020
CompletedFirst Posted
Study publicly available on registry
December 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2024
CompletedDecember 24, 2020
December 1, 2020
3.3 years
December 21, 2020
December 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Myocardial infarct size at 1 week
Myocardial infarct size at 1 week after acute myocardial infarction (quantified by Gadolinium-enhanced MRI).
1 week
Secondary Outcomes (6)
Myocardial infarct size
1 week
Myocardial infarct size based on culprit vessel with TIMI 0-1 blood flow
1 week
The proportion of viable myocardium and ratio of myocardial reperfusion
1 week
Composite end point at 1 week
1 week
Myocardial infarct size at 3 month
3 month
- +1 more secondary outcomes
Study Arms (2)
Tamiflu (Oseltamivir Phosphate Capsules)
EXPERIMENTALStandardized STEMI treatment + oseltamivir phosphate capsule (75mg, 2 times/day, 7days, oral)
no intervention
OTHERStandardized STEMI treatment + no intervention
Interventions
Treatment group vs. Control group
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tongji Hospitallead
Study Sites (1)
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dao Wen Wang, M.D., Ph.D
Tongji Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
December 21, 2020
First Posted
December 24, 2020
Study Start
March 1, 2020
Primary Completion
June 30, 2023
Study Completion
March 31, 2024
Last Updated
December 24, 2020
Record last verified: 2020-12