Flu vaccine after a heart attack or unstable angina
Influenza Vaccination After Acute Coronary Syndrome
This trial will test whether giving a flu shot to adults aged 18–80 who recently had acute coronary syndrome lowers the chance of future heart attacks, stroke, or death.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 6620 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT07259252 on ClinicalTrials.gov |
What this trial studies
This interventional study enrolls adults (18–80) with acute coronary syndrome and assigns them to receive either an influenza vaccine or a placebo shortly after hospital discharge. Investigators will track major cardiovascular events including cardiovascular death, myocardial infarction, and stroke, as well as secondary outcomes such as all-cause death, unplanned revascularization, heart-failure or arrhythmia hospitalizations, and stent thrombosis. Follow-up is conducted by phone at 1 month, 3 months, 6 months, and 12 months after discharge. The goal is to determine whether post-ACS influenza vaccination reduces subsequent adverse cardiac outcomes in a Chinese patient population.
Who should consider this trial
Good fit: Adults aged 18–80 who were hospitalized for acute coronary syndrome, can give written informed consent, have not received an influenza vaccine in the past year, and have no contraindications to the vaccine are ideal candidates.
Not a fit: Patients with life expectancy under one year, recent influenza vaccination, contraindications to the influenza vaccine, or serious comorbid conditions are less likely to receive benefit from participation.
Why it matters
Potential benefit: If successful, this approach could reduce cardiovascular deaths, heart attacks, strokes, and other serious cardiac complications after acute coronary syndrome.
How similar studies have performed: Previous randomized trials and meta-analyses have suggested influenza vaccination can lower cardiovascular events and mortality after cardiac events, so this approach has supporting evidence but is still being tested in different populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Wuhan, Hubei
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: Dao Wen Wang — Tongji Hospital
- Study coordinator: Yang Sun
- Email: sunyang.7@163.com
- Phone: +86-15527674573
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.