Influenza Vaccination After Acute Coronary Syndrome

NCT ID: NCT07259252

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

6620 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-03

Study Completion Date

2029-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Coronary Syndromes (ACS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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influenza vaccination

patients will receive influenza vaccination

Group Type EXPERIMENTAL

Influenza vaccine

Intervention Type DRUG

Patients receive injection of 0.5ml influenza vaccine

placebo

patients will receive placebo (PBS)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patients will receive injection of 0.5ml PBS

Interventions

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Influenza vaccine

Patients receive injection of 0.5ml influenza vaccine

Intervention Type DRUG

Placebo

Patients will receive injection of 0.5ml PBS

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dao Wen Wang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dao Wen Wang

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

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

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yang Sun

Role: CONTACT

+86-15527674573

Facility Contacts

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Yang Sun, MD

Role: primary

86-15527674573

Other Identifiers

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InVaACS

Identifier Type: -

Identifier Source: org_study_id

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