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Open-label Study of Neuraminidase Inhibitor Treatment in STEMI Patients

Primary Purpose

ST Elevation Myocardial Infarction, STEMI

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Oseltamivir phosphate capsules
Sponsored by
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Elevation Myocardial Infarction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Tamiflu (Oseltamivir Phosphate Capsules)

no intervention

Arm Description

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

Standardized STEMI treatment + no intervention

Outcomes

Primary Outcome Measures

Myocardial infarct size at 1 week
Myocardial infarct size at 1 week after acute myocardial infarction (quantified by Gadolinium-enhanced MRI).

Secondary Outcome Measures

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

Full Information

First Posted
December 21, 2020
Last Updated
December 23, 2020
Sponsor
Tongji Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04684498
Brief Title
Open-label Study of Neuraminidase Inhibitor Treatment in STEMI Patients
Official Title
An Open-label Study to Evaluate the Efficacy of Neuraminidase Inhibitor Treatment in ST-Elevation Myocardial Infarction (STEMI) Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Myocardial Infarction, STEMI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
382 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tamiflu (Oseltamivir Phosphate Capsules)
Arm Type
Experimental
Arm Description
Standardized STEMI treatment + oseltamivir phosphate capsule (75mg, 2 times/day, 7days, oral)
Arm Title
no intervention
Arm Type
Other
Arm Description
Standardized STEMI treatment + no intervention
Intervention Type
Drug
Intervention Name(s)
Oseltamivir phosphate capsules
Other Intervention Name(s)
Tamiflu
Intervention Description
Treatment group vs. Control group
Primary Outcome Measure Information:
Title
Myocardial infarct size at 1 week
Description
Myocardial infarct size at 1 week after acute myocardial infarction (quantified by Gadolinium-enhanced MRI).
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Myocardial infarct size
Description
Myocardial infarct size under the curve of creatine kinase-MB (CK-MB) and hypersensitive troponin I.
Time Frame
1 week
Title
Myocardial infarct size based on culprit vessel with TIMI 0-1 blood flow
Description
Evaluated by coronary angiography and CMR.
Time Frame
1 week
Title
The proportion of viable myocardium and ratio of myocardial reperfusion
Description
The proportion of viable myocardium and reperfusion was determined by the range of abnormal enhancement of gadolinium.
Time Frame
1 week
Title
Composite end point at 1 week
Description
A composite end point of cardiogenic shock, cardiac death, malignant arrhythmia, and resuscitated cardiac arrest (including ventricular fibrillation) at 1 week.
Time Frame
1 week
Title
Myocardial infarct size at 3 month
Description
Myocardial infarct size at 3 month after acute myocardial infarction (quantified by Gadolinium-enhanced MRI).
Time Frame
3 month
Title
Composite end point at 6 month
Description
Composite end point at 6 month, including all-cause death, reinfarction, heart failure after myocardial infarction, and rehospitalization of unstable angina at 6 month.
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luyun Wang, M.D., Ph.D
Phone
+86-02783665548
Email
wangluyun2004@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jiangang Jiang, M.D., Ph.D
Phone
+86-02783665548
Email
jiangjg618@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dao Wen Wang, M.D., Ph.D
Organizational Affiliation
Tongji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luyun Wang, M.D., Ph.D.
Phone
+86-02783665548
Email
wangluyun2004@126.com
First Name & Middle Initial & Last Name & Degree
Jiangang Jiang, M.D., Ph.D.
Phone
+86-02783665548
Email
jiangjg618@126.com

12. IPD Sharing Statement

Learn more about this trial

Open-label Study of Neuraminidase Inhibitor Treatment in STEMI Patients

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