ST Elevation Myocardial InfarctionPhase 4NCT04684498
Open-label Study of Neuraminidase Inhibitor Treatment in STEMI Patients
A Phase 4 study testing Oseltamivir phosphate capsules in people with ST Elevation Myocardial Infarction and STEMI, run by Tongji Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ST Elevation Myocardial Infarction, STEMI
- What is being tested?
- Oseltamivir phosphate capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 31 Mar 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Luyun Wang, M.D., Ph.D., +86-02783665548, wangluyun2004@126.com
Jiangang Jiang, M.D., Ph.D., +86-02783665548, jiangjg618@126.com
About this study
Official title: 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.
- Conditions
- ST Elevation Myocardial Infarction, STEMI
- Being tested
- Oseltamivir phosphate capsules
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oseltamivir phosphate capsulesDrug
Also called Tamiflu
Treatment group vs. Control group
| Study group | Role | What they receive |
|---|---|---|
| Tamiflu (Oseltamivir Phosphate Capsules) | Experimental | Standardized STEMI treatment + oseltamivir phosphate capsule (75mg, 2 times/day, 7days, oral) Receives: Drug: Oseltamivir phosphate capsules |
| no intervention | Other | Standardized STEMI treatment + no intervention Receives: Drug: Oseltamivir phosphate capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial infarct size at 1 week
Myocardial infarct size at 1 week after acute myocardial infarction (quantified by Gadolinium-enhanced MRI).
Measured: 1 week
Secondary outcomes (6)
Myocardial infarct size
Myocardial infarct size under the curve of creatine kinase-MB (CK-MB) and hypersensitive troponin I.
Measured: 1 week
Myocardial infarct size based on culprit vessel with TIMI 0-1 blood flow
Evaluated by coronary angiography and CMR.
Measured: 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.
Measured: 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.
Measured: 1 week
Myocardial infarct size at 3 month
Myocardial infarct size at 3 month after acute myocardial infarction (quantified by Gadolinium-enhanced MRI).
Measured: 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.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start1 Mar 2020
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 382 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dao Wen Wang, Tongji Hospital
- Investigators
- Dao Wen Wang, M.D., Ph.D, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684498
- Sponsor's protocol ID
- TJ-AMI-NI
- Status last verified
- Dec 2020
- First submitted
- 21 Dec 2020
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Evaluate the Efficacy of Neuraminidase Inhibitor Treatment in ST-Elevation Myocardial Infarction (STEMI) Patients
- ClinicalTrials.gov ID
- NCT04684498
- Acronym / sponsor ID
- TJ-AMI-NI
- Conditions
- ST Elevation Myocardial Infarction, STEMI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 382 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamiflu (Oseltamivir Phosphate Capsules) | Experimental | Drug: Oseltamivir phosphate capsulesStandardized STEMI treatment + oseltamivir phosphate capsule (75mg, 2 times/day, 7days, oral) |
| no intervention | Other | Drug: Oseltamivir phosphate capsulesStandardized STEMI treatment + no intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oseltamivir phosphate capsulesAlso: TamifluTreatment group vs. Control group | Drug | Tamiflu (Oseltamivir Phosphate Capsules), no intervention |
Primary outcome
Myocardial infarct size at 1 week
Time frame: 1 week
Myocardial infarct size at 1 week after acute myocardial infarction (quantified by Gadolinium-enhanced MRI).
6 secondary outcomes
Myocardial infarct size
Time frame: 1 week
Myocardial infarct size based on culprit vessel with TIMI 0-1 blood flow
Time frame: 1 week
The proportion of viable myocardium and ratio of myocardial reperfusion
Time frame: 1 week
Composite end point at 1 week
Time frame: 1 week
Myocardial infarct size at 3 month
Time frame: 3 month
Composite end point at 6 month
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dao Wen Wang, M.D., Ph.D principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oseltamivir phosphate capsules in people with ST Elevation Myocardial Infarction and STEMI, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luyun Wang, M.D., Ph.D (+86-02783665548, wangluyun2004@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial infarct size at 1 week (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2020.