Influenza Vaccination After Acute Coronary Syndrome

Tongji Hospital6,620 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

6,620

Conditions

Acute Coronary Syndromes (ACS)

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Secondary Outcomes

all cause death

The number of participants with all cause death till 12 months

Time frame: 12 months

cardiovascular death

The number of participants with cardiovascular death till 12 months

Time frame: 12 months

stroke

The number of participants with stroke till 12 months

Time frame: 12 months

myocardial infarction

The number of participants with myocardial infarction till 12 months

Time frame: 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

Time frame: 12 months

unplanned revascularization

The number of participants with unplanned revascularization till 12 months

Time frame: 12 months

stent thrombosis

The number of participants with stent thrombosis till 12 months

Time frame: 12 months

Influenza Vaccination After Acute Coronary Syndrome

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts