Influenza Vaccination After Acute Coronary Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Influenza vaccine, Placebo.
- Who it may be relevant to
- Registry conditions: Acute Coronary Syndromes (ACS). Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug Influenza vaccine
Patients receive injection of 0.5ml influenza vaccine - Drug Placebo
Patients will receive injection of 0.5ml PBS
Primary outcome measures
- Composite endpoint of cardiovascular death, myocardial infarction or stroke [Time frame: 12 months]
Secondary outcome measures (7)
- all cause death [Time frame: 12 months]
- cardiovascular death [Time frame: 12 months]
- stroke [Time frame: 12 months]
- myocardial infarction [Time frame: 12 months]
- unplanned hospitalization for heart failure or for arrhythmia [Time frame: 12 months]
- unplanned revascularization [Time frame: 12 months]
- stent thrombosis [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
Identifiers
NCT: NCT07259252 · InVaACS