Acute Coronary Syndromes (ACS)
Conditions
Brief summary
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: * Whether influenza vaccination can decrease events of cardiovascular death, MI, or stroke? * Whether influenza vaccination can decrease events of all cause death, unplanned revascularization, unplanned hospitalization for heart failure or for arrhythmia, stent thrombosis? 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.
Interventions
DRUGInfluenza vaccine
Patients receive injection of 0.5ml influenza vaccine
DRUGPlacebo
Patients will receive injection of 0.5ml PBS
Sponsors
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. ACS patient aged from 18 to 80 years. 2. Volunteer for the study and written informed consent.
Exclusion criteria
1. Participate in any drug clinical trials within 3 months. 2. Patients with life-threatening complications, or the researchers determined that the survival time of patients with no more than 1 years. 3. Serious neurological disease (Alzheimer's disease, Parkinson syndrome, progressive lower limbs or deaf patients). 4. Previous history of cancer or tumor, or pathological examination confirmed precancerous lesions (such as breast ductal carcinoma in situ, or atypical hyperplasia of the cervix). 5. Patients refused to comply with the requirements of this study to complete the research work. 6. Patients Received influenza vaccination within 1 year. 7. Patients with contraindications for influenza vaccination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite endpoint of cardiovascular death, myocardial infarction or stroke | 12 months | The number of participants with cardiovascular death, myocardial infarction or stroke (first occurring) till 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cardiovascular death | 12 months | The number of participants with cardiovascular death till 12 months |
| unplanned revascularization | 12 months | The number of participants with unplanned revascularization till 12 months |
| stent thrombosis | 12 months | The number of participants with stent thrombosis till 12 months |
| myocardial infarction | 12 months | The number of participants with myocardial infarction till 12 months |
| all cause death | 12 months | The number of participants with all cause death till 12 months |
| stroke | 12 months | The number of participants with stroke till 12 months |
| unplanned hospitalization for heart failure or for arrhythmia | 12 months | The number of participants with unplanned hospitalization for heart failure or for arrhythmia till 12 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| hospitalization for influenza | 12 months | The number of participants with hospitalization for influenza till 12 months |
| influenza like illness | 12 months | The number of participants with fever (body temperature ≥38℃) accompanied by cough or sore throat till 12 months |
Countries
China
Contacts
Primary ContactYang Sun
Outcome results
None listed