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Influenza Vaccination During Coronavirus Disease 2019 Outbreak After Acute Coronary Syndrome and Chronic Heart Failure (IV-ACS&CHF)

Primary Purpose

Acute Coronary Syndrome, Chronic Heart Failure

Status
Recruiting
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Ultrix Quadri
Sponsored by
Samara Regional Cardiology Dispensary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Coronary Syndrome focused on measuring acute coronary syndrome, influenza vaccination, prognosis, chronic heart failure

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with a diagnosis of ACS with transformation to AMI or unstable angina
  • Patients with a diagnosis of CHF Written informed consent.

Exclusion Criteria:

  • • 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.
    • Subjects with endogenic or iatrogenic immunosuppression that may result in reduced immunization response.
    • Inability to provide informed consent.
    • Age below 65 years.

Sites / Locations

  • Samara Regional Cardiology DispanseryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Vaccinated

Not vaccinated

Arm Description

vaccinated ACS & CHF patients over 65 years

not vaccinated ACS & CHF patients over 65 years

Outcomes

Primary Outcome Measures

Primary endpoint
сomposite of all-cause death, MI, or stent thrombosis at 12 months

Secondary Outcome Measures

Secondary endpoint
The number of participants with all-cause death and myocardial infarction till 1 year
Secondary endpoint
Safety of vaccination (incidence of side effects)

Full Information

First Posted
December 19, 2021
Last Updated
January 30, 2022
Sponsor
Samara Regional Cardiology Dispensary
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1. Study Identification

Unique Protocol Identification Number
NCT05232292
Brief Title
Influenza Vaccination During Coronavirus Disease 2019 Outbreak After Acute Coronary Syndrome and Chronic Heart Failure
Acronym
IV-ACS&CHF
Official Title
Influenza Vaccination During COVID19 Outbreak After Acute Coronary Syndrome and Chronic Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samara Regional Cardiology Dispensary

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Chronic Heart Failure
Keywords
acute coronary syndrome, influenza vaccination, prognosis, chronic heart failure

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vaccinated
Arm Type
Active Comparator
Arm Description
vaccinated ACS & CHF patients over 65 years
Arm Title
Not vaccinated
Arm Type
No Intervention
Arm Description
not vaccinated ACS & CHF patients over 65 years
Intervention Type
Biological
Intervention Name(s)
Ultrix Quadri
Intervention Description
vaccination by Ultrix Quadri against flu
Primary Outcome Measure Information:
Title
Primary endpoint
Description
сomposite of all-cause death, MI, or stent thrombosis at 12 months
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
Secondary endpoint
Description
The number of participants with all-cause death and myocardial infarction till 1 year
Time Frame
up to 1 year
Title
Secondary endpoint
Description
Safety of vaccination (incidence of side effects)
Time Frame
1 week after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a diagnosis of ACS with transformation to AMI or unstable angina Patients with a diagnosis of CHF Written informed consent. Exclusion Criteria: • 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. Subjects with endogenic or iatrogenic immunosuppression that may result in reduced immunization response. Inability to provide informed consent. Age below 65 years.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dmitry Duplyakov, Prof
Phone
89277297273
Email
duplyakov@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dmitry Duplyakov, Prof
Organizational Affiliation
SOKKD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samara Regional Cardiology Dispansery
City
Samara
ZIP/Postal Code
443070
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dmitry Duplyakov, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Influenza Vaccination During Coronavirus Disease 2019 Outbreak After Acute Coronary Syndrome and Chronic Heart Failure

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