Acute Coronary SyndromePhase 4IV-ACS&CHFNCT05232292
Influenza Vaccination During Coronavirus Disease 2019 Outbreak After Acute Coronary Syndrome and Chronic Heart Failure
A Phase 4 study testing Ultrix Quadri in people with Acute Coronary Syndrome and Chronic Heart Failure, run by Samara Regional Cardiology Dispensary at 1 site in Russia.
Trial summary
Study Description: Background: Well-known fact that the number of cardiovascular diseases is on the rise during influenza epidemic. It is conceivable that influenza may precipitate plaque rupture, increase cytokines with central roles in plaque destabilization and trigger the coagulation cascade. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Chronic Heart Failure
- What is being tested?
- Ultrix Quadri
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- 6 Oct 2021to 31 May 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with a diagnosis of ACS with transformation to AMI or unstable angina
- Patients with a diagnosis of CHF Written informed consent.
Who cannot join
- • Influenza vaccination during the current influenza season or anticipating to be vaccinated during the current influenza season.
- COVID-19 vaccination during 30 days
- Indication for influenza vaccination for some indication other than myocardial infarction.
- Severe allergy to eggs or previous allergic reaction to influence vaccine.
- Suspicion of febrile illness or acute, ongoing infection.
- Hypersensitivity to the active substances or ingredients of Ultrix Quadri or against any residues, such as eggs (ovalbumin or chicken proteins), neomycin, formaldehyde and octoxinol.
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- Subjects with endogenic or iatrogenic immunosuppression that may result in reduced immunization response.
- Inability to provide informed consent.
- Age below 65 years.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Samara Regional Cardiology Dispansery
Samara, 443070
Dmitry Duplyakov, MD, PhD
About this study
Official title: Influenza Vaccination During COVID19 Outbreak After Acute Coronary Syndrome and Chronic Heart Failure
Study Description:
Background: Well-known fact that the number of cardiovascular diseases is on the rise during influenza epidemic. It is conceivable that influenza may precipitate plaque rupture, increase cytokines with central roles in plaque destabilization and trigger the coagulation cascade. A number of studies have shown that the risk of cardiovascular complications (ACS, stroke, CHF decompensation, cardiac arrhythmias) seem to be reduced following influenza vaccination. The Influenza Vaccination After Myocardial Infarction study data published in September 2021 have demonstrated a significant decrease of mortality (by 40%) during 1 year of follow-up in patients with myocardial infarction (MI) who has been vaccinated during the first 72 hours.
Read more
Objective: the objective is to find out whether influenza vaccination protects against cardiovascular events and death in ACS \& CHF patients vaccinated during hospitalization Methods: Population: 400 patients aged 65 and older with acute coronary syndrome are randomized 1:1 and followed up via telephone calls and registries (AIS "Mortality").
Patients will be included in the study in cardiology departments № 1, 2, 3, 5, 6 of the State Budgetary Healthcare Institution "Samara Regional Clinical Cardiology Dispensary named after V.P. Polyakov" Intervention: Influenza vaccination. Control: group of unvaccinated patients. Planned study period is 1 year.
Read the detailed description
Detailed Description:
Name of investigational treatment: Influenza vaccine ("Ultrix Quadri"™) Planned study period: October - December 2021 ((influenza season) Long-term follow up to 365 days from the moment of vaccination of the last included patient (approximately November-December 2022) via phone calls.
Methodology: vaccination will be start after informed consent on the day of leaving hospital with "Ultrix Quadri"™ vaccine Intervention Model: Parallel Assignment Number of subjects: 400 Number of vaccinated patients is 200 Number of patients with placebo is 200 Primary endpoint: сomposite of all-cause death, MI, or stent thrombosis at 12 months Secondary endpoints
- The number of participants with all-cause death till 1 year (key secondary outcome)
- The number of participants with myocardial infarction till 1 year (key secondary outcome)
- The number of participants with stent thrombosis till 1 year (key secondary outcome)
- The number of participants with cardiovascular death till 1 year (key secondary outcome)
- The number of participants with a new revascularization till 1 year
- The number of participants with cardiovascular death, a new myocardial infarction or stent thrombosis (first occurring) till 1 year
- The number of participants with stroke, including transient ischemic attack (TIA) till 1 year
- The number of participants with hospitalization for heart failure till 1 year
- The number of participants with hospitalization for arrhythmia till 1 year
- Safety of vaccination (incidence of side effects)
Follow up by telephone and registry information (AIS "Mortality"): the follow up for endpoints will be performed using telephone contacts with the patients or first degree relatives.
Purpose of phone calls:
- to assess the safety of vaccination the day after vaccination (T1) 7 (± 1) day after vaccination (T2)
- to study the effectiveness 365 (± 5) days after vaccination (T3)
Reporting for adverse events: The patients will be informed to contact the investigator or study nurse if any adverse event should occur during this timeframe.
Study Start Date: September 2021 Actual Primary Completion Date (safety assessment): December 2021 Actual Study Completion Date (efficiency mark): December 2022 Experimental Drug: influenza vaccine Ultrix Quadri Standard influenza vaccine administered as a deep subcutaneous injection at one occasion per subject.
The experimental drug is not administered to patients in the control group.
Eligibility Criteria:
Ages Eligible for Study: 65 Years and older (Adult, Older Adult) Sexes Eligible for Study: All
Inclusion Criteria:
- Patients with a diagnosis of ACS with transformation to acute MI or unstable angina Patients with a diagnosis of Chronic Heart Failure due to different reasons
- Written informed consent.
Exclusion Criteria:
- Influenza vaccination during the current influenza season or anticipating to be vaccinated during the current influenza season.
- Coronavirus disease 2019 vaccination during 30 days
- Indication for influenza vaccination for some indication other than myocardial infarction.
- Severe allergy to eggs or previous allergic reaction to influence vaccine.
- Suspicion of febrile illness or acute, ongoing infection.
- Hypersensitivity to the active substances or ingredients of Ultrix Quadri or against any residues, such as eggs (ovalbumin or chicken proteins), neomycin, formaldehyde and octoxinol.
- Subjects with endogenic or iatrogenic immunosuppression that may result in reduced immunization response.
- Inability to provide informed consent.
- Age below 65 years.
- Conditions
- Acute Coronary Syndrome, Chronic Heart Failure
- Being tested
- Ultrix Quadri
- Keywords
- acute coronary syndrome, influenza vaccination, prognosis, chronic heart failure
- Medical subject headings
- Acute Coronary Syndrome, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrix QuadriBiological
vaccination by Ultrix Quadri against flu
| Study group | Role | What they receive |
|---|---|---|
| Vaccinated | Active comparator | vaccinated ACS \& CHF patients over 65 years Receives: Biological: Ultrix Quadri |
| Not vaccinated | No intervention | not vaccinated ACS \& CHF patients over 65 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint
сomposite of all-cause death, MI, or stent thrombosis at 12 months
Measured: up to 1 year
Secondary outcomes (2)
Secondary endpoint
The number of participants with all-cause death and myocardial infarction till 1 year
Measured: up to 1 year
Secondary endpoint
Safety of vaccination (incidence of side effects)
Measured: 1 week after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start6 Oct 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samara Regional Cardiology Dispensary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dmitry Duplyakov FESC, Samara Regional Cardiology Dispensary
- Investigators
- Dmitry Duplyakov, Prof, Principal investigator, SOKKD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232292
- Sponsor's protocol ID
- SOKKD003
- Acronym
- IV-ACS&CHF
- Status last verified
- Jan 2022
- First submitted
- 19 Dec 2021
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influenza Vaccination During COVID19 Outbreak After Acute Coronary Syndrome and Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT05232292
- Acronym / sponsor ID
- IV-ACS&CHF / SOKKD003
- Conditions
- Acute Coronary Syndrome, Chronic Heart Failure
- Keywords
- acute coronary syndrome, influenza vaccination, prognosis, chronic heart failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Samara Regional Cardiology DispensaryUniversity, hospital or other
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 9 Feb 2022 (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.
Study Description:
Background: Well-known fact that the number of cardiovascular diseases is on the rise during influenza epidemic. It is conceivable that influenza may precipitate plaque rupture, increase cytokines with central roles in plaque destabilization and trigger the coagulation cascade. A number of studies have shown that the risk of cardiovascular complications (ACS, stroke, CHF decompensation, cardiac arrhythmias) seem to be reduced following influenza vaccination. The Influenza Vaccination After Myocardial Infarction study data published in September 2021 have demonstrated a significant decrease of mortality (by 40%) during 1 year of follow-up in patients with myocardial infarction (MI) who has been vaccinated during the first 72 hours.
Objective: the objective is to find out whether influenza vaccination protects against cardiovascular events and death in ACS \& CHF patients vaccinated during hospitalization Methods: Population: 400 patients aged 65 and older with acute coronary syndrome are randomized 1:1 and followed up via telephone calls and registries (AIS "Mortality").
Patients will be included in the study in cardiology departments № 1, 2, 3, 5, 6 of the State Budgetary Healthcare Institution "Samara Regional Clinical Cardiology Dispensary named after V.P. Polyakov" Intervention: Influenza vaccination. Control: group of unvaccinated patients. Planned study period is 1 year.
Detailed description
Detailed Description:
Name of investigational treatment: Influenza vaccine ("Ultrix Quadri"™) Planned study period: October - December 2021 ((influenza season) Long-term follow up to 365 days from the moment of vaccination of the last included patient (approximately November-December 2022) via phone calls.
Methodology: vaccination will be start after informed consent on the day of leaving hospital with "Ultrix Quadri"™ vaccine Intervention Model: Parallel Assignment Number of subjects: 400 Number of vaccinated patients is 200 Number of patients with placebo is 200 Primary endpoint: сomposite of all-cause death, MI, or stent thrombosis at 12 months Secondary endpoints
- The number of participants with all-cause death till 1 year (key secondary outcome)
- The number of participants with myocardial infarction till 1 year (key secondary outcome)
- The number of participants with stent thrombosis till 1 year (key secondary outcome)
- The number of participants with cardiovascular death till 1 year (key secondary outcome)
- The number of participants with a new revascularization till 1 year
- The number of participants with cardiovascular death, a new myocardial infarction or stent thrombosis (first occurring) till 1 year
- The number of participants with stroke, including transient ischemic attack (TIA) till 1 year
- The number of participants with hospitalization for heart failure till 1 year
- The number of participants with hospitalization for arrhythmia till 1 year
- Safety of vaccination (incidence of side effects)
Follow up by telephone and registry information (AIS "Mortality"): the follow up for endpoints will be performed using telephone contacts with the patients or first degree relatives.
Purpose of phone calls:
- to assess the safety of vaccination the day after vaccination (T1) 7 (± 1) day after vaccination (T2)
- to study the effectiveness 365 (± 5) days after vaccination (T3)
Reporting for adverse events: The patients will be informed to contact the investigator or study nurse if any adverse event should occur during this timeframe.
Study Start Date: September 2021 Actual Primary Completion Date (safety assessment): December 2021 Actual Study Completion Date (efficiency mark): December 2022 Experimental Drug: influenza vaccine Ultrix Quadri Standard influenza vaccine administered as a deep subcutaneous injection at one occasion per subject.
The experimental drug is not administered to patients in the control group.
Eligibility Criteria:
Ages Eligible for Study: 65 Years and older (Adult, Older Adult) Sexes Eligible for Study: All
Inclusion Criteria:
- Patients with a diagnosis of ACS with transformation to acute MI or unstable angina Patients with a diagnosis of Chronic Heart Failure due to different reasons
- Written informed consent.
Exclusion Criteria:
- Influenza vaccination during the current influenza season or anticipating to be vaccinated during the current influenza season.
- Coronavirus disease 2019 vaccination during 30 days
- Indication for influenza vaccination for some indication other than myocardial infarction.
- Severe allergy to eggs or previous allergic reaction to influence vaccine.
- Suspicion of febrile illness or acute, ongoing infection.
- Hypersensitivity to the active substances or ingredients of Ultrix Quadri or against any residues, such as eggs (ovalbumin or chicken proteins), neomycin, formaldehyde and octoxinol.
- Subjects with endogenic or iatrogenic immunosuppression that may result in reduced immunization response.
- Inability to provide informed consent.
- Age below 65 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccinated | Active comparator | Biological: Ultrix Quadrivaccinated ACS \& CHF patients over 65 years |
| Not vaccinated | No intervention | –not vaccinated ACS \& CHF patients over 65 years |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients with a diagnosis of ACS with transformation to AMI or unstable angina
- Patients with a diagnosis of CHF Written informed consent.
Key exclusion criteria (9 listed)
- • Influenza vaccination during the current influenza season or anticipating to be vaccinated during the current influenza season.
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 |
|---|---|---|
| Ultrix Quadrivaccination by Ultrix Quadri against flu | Biological | Vaccinated |
Primary outcome
Primary endpoint
Time frame: up to 1 year
сomposite of all-cause death, MI, or stent thrombosis at 12 months
2 secondary outcomes
Secondary endpoint
Time frame: up to 1 year
Secondary endpoint
Time frame: 1 week after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- 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. This study is not recruiting at the moment.
Dmitry Duplyakov, Prof principal investigator
SOKKD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ultrix Quadri in people with Acute Coronary Syndrome and Chronic Heart Failure, run by Samara Regional Cardiology Dispensary at 1 site in Russia.
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 9 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: status not confirmed, as of the sponsor's last update on 9 Feb 2022. 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 Russia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dmitry Duplyakov, Prof (89277297273, duplyakov@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint (time frame: up to 1 year). 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 9 Feb 2022.