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RecruitingNCT07259252InVaACSUpdated Jan 13, 2026

Influenza Vaccination After Acute Coronary Syndrome

An interventional study of Influenza vaccine and Placebo in Acute Coronary Syndromes (ACS), sponsored by Tongji Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-13.

Sponsored by Tongji Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
6,620
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Coronary Syndromes (ACS)
03

In context

Acute Coronary Syndrome

1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.

This study's planned enrollment of 6,620 is above the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

Tongji Hospital is the lead sponsor of 373 studies on the registry; 204 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
6,620 participants (estimated)

Study arms

  • Experimental
    influenza vaccination

    patients will receive influenza vaccination

    Drug: Influenza vaccine

  • Placebo comparator
    placebo

    patients will receive placebo (PBS)

    Drug: Placebo

Interventions

  • DrugInfluenza vaccine

    Patients receive injection of 0.5ml influenza vaccine

  • DrugPlacebo

    Patients will receive injection of 0.5ml PBS

06

What researchers measure

Primary outcomes

  1. 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

  1. all cause death

    The number of participants with all cause death till 12 months

    Time frame: 12 months

  2. cardiovascular death

    The number of participants with cardiovascular death till 12 months

    Time frame: 12 months

  3. stroke

    The number of participants with stroke till 12 months

    Time frame: 12 months

  4. myocardial infarction

    The number of participants with myocardial infarction till 12 months

    Time frame: 12 months

  5. 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

  6. unplanned revascularization

    The number of participants with unplanned revascularization till 12 months

    Time frame: 12 months

  7. stent thrombosis

    The number of participants with stent thrombosis till 12 months

    Time frame: 12 months

Other outcomes

  1. influenza like illness

    The number of participants with fever (body temperature ≥38℃) accompanied by cough or sore throat till 12 months

    Time frame: 12 months

  2. hospitalization for influenza

    The number of participants with hospitalization for influenza till 12 months

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei 430030, China
    • Yang Sun, MD · Contact · sunyang.7@163.com · 86-15527674573
    • Dao Wen Wang, MD, PhD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07259252
Lead sponsor
Tongji Hospital
Responsible party
Dao Wen Wang (Professor, Tongji Hospital) — Principal investigator
First posted
Dec 2, 2025
Start date
Dec 3, 2025
Primary completion
Mar 30, 2029 (estimated)
Completion
Mar 30, 2029 (estimated)
Last update
Jan 13, 2026

Study contacts

Yang Sun
Contact
sunyang.7@163.com
+86-15527674573
Dao Wen Wang
principal investigator · Tongji Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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