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Open-label Study of Neuraminidase Inhibitor Treatment in STEMI Patients

NCT ID: NCT04684498

Last Updated: 2020-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

382 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2024-03-31

Brief Summary

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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

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Conditions

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ST Elevation Myocardial Infarction STEMI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tamiflu (Oseltamivir Phosphate Capsules)

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

Group Type EXPERIMENTAL

Oseltamivir phosphate capsules

Intervention Type DRUG

Treatment group vs. Control group

no intervention

Standardized STEMI treatment + no intervention

Group Type OTHER

Oseltamivir phosphate capsules

Intervention Type DRUG

Treatment group vs. Control group

Interventions

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Oseltamivir phosphate capsules

Treatment group vs. Control group

Intervention Type DRUG

Other Intervention Names

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Tamiflu

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dao Wen Wang

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dao Wen Wang, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

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Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Luyun Wang, M.D., Ph.D

Role: CONTACT

Phone: +86-02783665548

Email: [email protected]

Jiangang Jiang, M.D., Ph.D

Role: CONTACT

Phone: +86-02783665548

Email: [email protected]

Facility Contacts

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Luyun Wang, M.D., Ph.D.

Role: primary

Jiangang Jiang, M.D., Ph.D.

Role: backup

Other Identifiers

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TJ-AMI-NI

Identifier Type: -

Identifier Source: org_study_id