Ignite Creation Date:
2024-05-06 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 2:24 PM
Study NCT ID:
NCT05232292
Status:
UNKNOWN
Last Update Posted:
2022-02-09
First Post:
2021-12-19
Brief Title:
Influenza Vaccination During Coronavirus Disease 2019 Outbreak After Acute Coronary Syndrome and Chronic Heart Failure
Sponsor:
Samara Regional Cardiology Dispensary
Organization:
Samara Regional Cardiology Dispensary
Study Overview
Official Title:
Influenza Vaccination During COVID19 Outbreak After Acute Coronary Syndrome and Chronic Heart Failure
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IV-ACSCHF
Brief 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 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 11 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 VP Polyakov Intervention Influenza vaccination Control group of unvaccinated patients Planned study period is 1 year
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 11 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 VP 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None