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NCT Number: NCT07259252

Influenza Vaccination After Acute Coronary Syndrome

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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Key information

Conditions

Acute Coronary Syndromes (ACS) Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location status: Recruiting

Location contact

Dao Wen Wang, MD, PhD

PRINCIPAL_INVESTIGATOR

Yang Sun, MD

CONTACT

[email protected]

86-15527674573

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ACS patient aged from 18 to 80 years.
  • Volunteer for the study and written informed consent.

Exclusion criteria

  • 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.

Treatment and study plan

Influenza vaccine

Drug

Patients receive injection of 0.5ml influenza vaccine

Placebo

Drug

Patients will receive injection of 0.5ml PBS

Primary outcomes

  1. Composite endpoint of cardiovascular death, myocardial infarction or stroke

    Time frame: 12 months

    The number of participants with cardiovascular death, myocardial infarction or stroke (first occurring) till 12 months.

Secondary outcomes

  1. all cause death

    Time frame: 12 months

    The number of participants with all cause death till 12 months

  2. cardiovascular death

    Time frame: 12 months

    The number of participants with cardiovascular death till 12 months

  3. stroke

    Time frame: 12 months

    The number of participants with stroke till 12 months

  4. myocardial infarction

    Time frame: 12 months

    The number of participants with myocardial infarction till 12 months

  5. unplanned hospitalization for heart failure or for arrhythmia

    Time frame: 12 months

    The number of participants with unplanned hospitalization for heart failure or for arrhythmia till 12 months

  6. unplanned revascularization

    Time frame: 12 months

    The number of participants with unplanned revascularization till 12 months

  7. stent thrombosis

    Time frame: 12 months

    The number of participants with stent thrombosis till 12 months

Other outcomes

  1. influenza like illness

    Time frame: 12 months

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

  2. hospitalization for influenza

    Time frame: 12 months

    The number of participants with hospitalization for influenza till 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Yang Sun

CONTACT

[email protected]

+86-15527674573

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Acronym: InVaACS

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Dec 2, 2025
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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