Influenza Vaccination After Acute Coronary Syndrome (InVaACS)

Tongji Hospital

Status: Enrolling

Conditions: Acute Coronary Syndromes (ACS)

Treatments: Drug: Placebo; Drug: Influenza vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT07259252

InVaACS

Details and patient eligibility

About

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.

Enrollment: 6,620 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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6,620 participants in 2 patient groups, including a placebo group

influenza vaccination

Experimental group

Description:

patients will receive influenza vaccination

Treatment:

Drug: Influenza vaccine

placebo

Placebo Comparator group

Description:

patients will receive placebo (PBS)

Treatment:

Drug: Placebo