Acute Coronary Syndromes (ACS)InVaACSNCT07259252
Influenza Vaccination After Acute Coronary Syndrome
A study testing Influenza vaccine in people with Acute Coronary Syndromes (ACS), run by Tongji Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndromes (ACS)
- What is being tested?
- Influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,620 participants
- Where
- 1 siteChina
- Study dates
- 3 Dec 2025to 30 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ACS patient aged from 18 to 80 years.
- Volunteer for the study and written informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Yang Sun, MD, 86-15527674573, sunyang.7@163.com
Dao Wen Wang, MD, PhD
About this study
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?
Read more
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.
- Conditions
- Acute Coronary Syndromes (ACS)
- Being tested
- Influenza vaccine, Placebo
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza vaccineDrug
Patients receive injection of 0.5ml influenza vaccine
PlaceboDrug
Patients will receive injection of 0.5ml PBS
| Study group | Role | What they receive |
|---|---|---|
| influenza vaccination | Experimental | patients will receive influenza vaccination Receives: Drug: Influenza vaccine |
| placebo | Placebo comparator | patients will receive placebo (PBS) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (7)
all cause death
The number of participants with all cause death till 12 months
Measured: 12 months
cardiovascular death
The number of participants with cardiovascular death till 12 months
Measured: 12 months
stroke
The number of participants with stroke till 12 months
Measured: 12 months
myocardial infarction
The number of participants with myocardial infarction till 12 months
Measured: 12 months
unplanned hospitalization for heart failure or for arrhythmia
The number of participants with unplanned hospitalization for heart failure or for arrhythmia till 12 months
Measured: 12 months
unplanned revascularization
The number of participants with unplanned revascularization till 12 months
Measured: 12 months
stent thrombosis
The number of participants with stent thrombosis till 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start3 Dec 2025
- Primary completion30 Mar 2029 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary Syndromes (ACS)Studies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6,620 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dao Wen Wang, Tongji Hospital
- Investigators
- Dao Wen Wang, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259252
- Sponsor's protocol ID
- InVaACS
- Acronym
- InVaACS
- Status last verified
- Jan 2026
- First submitted
- 21 Nov 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influenza Vaccination After Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT07259252
- Acronym / sponsor ID
- InVaACS / InVaACS
- Conditions
- Acute Coronary Syndromes (ACS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,620 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| influenza vaccination | Experimental | Drug: Influenza vaccinepatients will receive influenza vaccination |
| placebo | Placebo comparator | Drug: Placebopatients will receive placebo (PBS) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ACS patient aged from 18 to 80 years.
- Volunteer for the study and written informed consent.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza vaccinePatients receive injection of 0.5ml influenza vaccine | Drug | influenza vaccination |
| PlaceboPatients will receive injection of 0.5ml PBS | Drug | placebo |
Primary outcome
Composite endpoint of cardiovascular death, myocardial infarction or stroke
Time frame: 12 months
The number of participants with cardiovascular death, myocardial infarction or stroke (first occurring) till 12 months.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dao Wen Wang principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Influenza vaccine in people with Acute Coronary Syndromes (ACS), run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Sun (+86-15527674573, sunyang.7@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint of cardiovascular death, myocardial infarction or stroke (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.