Influenza Vaccination After Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6,620
- 试验地点
- 1
- 主要终点
- Composite endpoint of cardiovascular death, myocardial infarction or stroke
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ACS patient aged from 18 to 80 years.
- •Volunteer for the study and written informed consent.
排除标准
- •Participate in any drug clinical trials within 3 months.
- •Patients with life-threatening complications, or the researchers determined that the survival time of patients with no more than 1 years.
- •Serious neurological disease (Alzheimer's disease, Parkinson syndrome, progressive lower limbs or deaf patients).
- •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).
- •Patients refused to comply with the requirements of this study to complete the research work.
- •Patients Received influenza vaccination within 1 year.
- •Patients with contraindications for influenza vaccination.
研究组 & 干预措施
influenza vaccination
patients will receive influenza vaccination
干预措施: Influenza vaccine (Drug)
placebo
patients will receive placebo (PBS)
干预措施: Placebo (Drug)
结局指标
主要结局
Composite endpoint of cardiovascular death, myocardial infarction or stroke
时间窗: 12 months
The number of participants with cardiovascular death, myocardial infarction or stroke (first occurring) till 12 months.
次要结局
- all cause death(12 months)
- cardiovascular death(12 months)
- stroke(12 months)
- myocardial infarction(12 months)
- unplanned hospitalization for heart failure or for arrhythmia(12 months)
- unplanned revascularization(12 months)
- stent thrombosis(12 months)