NCT07259252

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,620

participants targeted

Target at P75+ for not_applicable

Timeline
35mo left

Started Dec 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Dec 2025Mar 2029

First Submitted

Initial submission to the registry

November 21, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

December 3, 2025

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2029

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

3.3 years

First QC Date

November 21, 2025

Last Update Submit

January 10, 2026

Conditions

Acute Coronary Syndromes (ACS)

Outcome Measures

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.

    12 months

Secondary Outcomes (7)

  • all cause death

    12 months

  • cardiovascular death

    12 months

  • stroke

    12 months

  • myocardial infarction

    12 months

  • unplanned hospitalization for heart failure or for arrhythmia

    12 months

  • +2 more secondary outcomes

Other Outcomes (2)

  • influenza like illness

    12 months

  • hospitalization for influenza

    12 months

Study Arms (2)

influenza vaccination

EXPERIMENTAL

patients will receive influenza vaccination

Drug: Influenza vaccine

placebo

PLACEBO COMPARATOR

patients will receive placebo (PBS)

Drug: Placebo

Interventions

Influenza vaccineDRUG

Patients receive injection of 0.5ml influenza vaccine

influenza vaccination
PlaceboDRUG

Patients will receive injection of 0.5ml PBS

placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Dao Wen Wang

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Sun

CONTACT

+86-15527674573sunyang.7@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 21, 2025

First Posted

December 2, 2025

Study Start

December 3, 2025

Primary Completion (Estimated)

March 30, 2029

Study Completion (Estimated)

March 30, 2029

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)