Health TrialsbyHealthPanel

Influenza Vaccination After Acute Coronary Syndrome

ConditionAcute Coronary Syndromes (ACS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTongji Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ACS patient aged from 18 to 80 years.

Volunteer for the study and written informed consent.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Influenza vaccine

    Drug

    Patients receive injection of 0.5ml influenza vaccine

  • Placebo

    Drug

    Patients will receive injection of 0.5ml PBS

Treatment groups

6,620 Participants
are divided into 2 treatment groups
Group A: influenza vaccinationExperimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention

Trial outcomes

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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tongji Hospital

Lead sponsor

Source ClinicalTrials.gov
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