Influenza Vaccination After Acute Coronary Syndrome

NCT07259252 — Not applicable, Recruiting, 6620 participants, Tongji Hospital

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Registry	NCT07259252, acronym InVaACS
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, prevention
Enrollment	6620 (Estimated)
Sponsor	Tongji Hospital (Other)
Conditions	Acute Coronary Syndromes (ACS)
Interventions	Influenza vaccine, Placebo (Drug)
Dates	start 2025-12-03, primary completion 2029-03-30 (estimated), completion 2029-03-30 (estimated), first posted 2025-12-02, last updated 2026-01-13
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
influenza vaccination	Experimental	Drug: Influenza vaccine	patients will receive influenza vaccination
placebo	Placebo comparator	Drug: Placebo	patients will receive placebo (PBS)

Influenza vaccine (Drug): Patients receive injection of 0.5ml influenza vaccine
Placebo (Drug): Patients will receive injection of 0.5ml PBS

+Outcome measures

Primary outcomes

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 outcomes

all cause death [12 months]: The number of participants with all cause death till 12 months
cardiovascular death [12 months]: The number of participants with cardiovascular death till 12 months
stroke [12 months]: The number of participants with stroke till 12 months
myocardial infarction [12 months]: The number of participants with myocardial infarction 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
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

Other outcomes

influenza like illness [12 months]: The number of participants with fever (body temperature ≥38℃) accompanied by cough or sore throat till 12 months
hospitalization for influenza [12 months]: The number of participants with hospitalization for influenza till 12 months

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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.

+Locations (1)

Facility	City	Country	Status
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan, Hubei	China	Recruiting

+Investigators

Dao Wen Wang, Principal investigator, Tongji Hospital