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The goal of this clinical trial is to learn if influenza vaccination can prevent adverse cardiac events in Chinese acute coronary syndrome patients. The main questions it aims to answer are:
If there is a comparison group: Researchers will compare influenza vaccination and placebo to see if adverse cardiac events decrease.
Participants will receive an influenza vaccination or placebo after enrollment and phone calls for follow-up at 1 month, 3 months, 6 months and 1 year after discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| influenza vaccination | Experimental | patients will receive influenza vaccination |
|
| placebo | Placebo Comparator | patients will receive placebo (PBS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza vaccine | Drug | Patients receive injection of 0.5ml influenza vaccine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Composite endpoint of cardiovascular death, myocardial infarction or stroke | The number of participants with cardiovascular death, myocardial infarction or stroke (first occurring) till 12 months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| all cause death | The number of participants with all cause death till 12 months | 12 months |
| cardiovascular death | The number of participants with cardiovascular death till 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| influenza like illness | The number of participants with fever (body temperature ≥38℃) accompanied by cough or sore throat till 12 months | 12 months |
| hospitalization for influenza | The number of participants with hospitalization for influenza till 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Sun | Contact | +86-15527674573 | sunyang.7@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Dao Wen Wang | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Placebo |
| Drug |
Patients will receive injection of 0.5ml PBS |
|
| 12 months |
| stroke | The number of participants with stroke till 12 months | 12 months |
| myocardial infarction | The number of participants with myocardial infarction till 12 months | 12 months |
| unplanned hospitalization for heart failure or for arrhythmia | The number of participants with unplanned hospitalization for heart failure or for arrhythmia till 12 months | 12 months |
| unplanned revascularization | The number of participants with unplanned revascularization till 12 months | 12 months |
| stent thrombosis | The number of participants with stent thrombosis till 12 months | 12 months |
| 12 months |