Evaluation of the Effectiveness of Double Dose Influenza Vaccination to Reduce Major Cardiovascular Events After an Acute Coronary Syndrome
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 1,801
- Locations
- 22
- Primary Endpoint
- Hierarchical composite endpoint consisting of death, myocardial infarction, stroke, unstable angina hospitalization, heart failure hospitalization, urgent coronary revascularization or respiratory infections hospitalizations
Study Overview
Brief Summary
Cardiovascular disease has a great burden in the context of public health, as well as the low pharmacological adherence of patients who have chronic non-transmissible diseases. However, the investigators do not have data on the efficacy of vaccination to reduce cardiovascular events in the acute coronary syndromes, and the few studies evaluating the cardioprotective potential of the influenza vaccine were conducted in countries with well defined seasonalities, divergent of Brazil, that presents a constant viral circulation during all months of the year and distinct among its regions. Therefore, study evaluating higher dose vaccination in a period that contemplates the seasonality of the influenza virus in Brazil may bring important findings to different scientific gaps, as well as clarify questions about the possible benefit of doubled vaccination - which does not present contraindications - immediately after a atherothrombotic event. If it shows real benefit, it could also be a future therapeutic tool adjuvant to traditional drug therapy in the prevention of cardiovascular events.
Detailed Description
Phase III, randomized, controlled, multicenter, open-label, superiority, 1:1 allocation, blind assessment of clinical outcomes and intention-to-treat analysis clinical trial to determine whether increased doses(double dose) of influenza vaccine in the hospital phase, when compared to usual dose vaccination (30 days of randomization), decreases the risk of cardiovascular and respiratory events. Hospitalizations due to COVID-19 are excluded from the respiratory infection component of the primary outcome.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Participation in another clinical trial with vaccines;
- •Refusal to provide consent;
- •Hypersensitivity and/or anaphylaxis to any component of the vaccine, or Guillain-Barré within 6 weeks after previous influenza vaccine;
- •Have already received the influenza vaccine with the same strains used in the study within the last 12 months of inclusion in the study
- •Breastfeeding women;
- •Pregnant women;
- •Presenting an acute coronary syndrome during months of December, January, and February.
- •Acute coronary syndrome hospitalization >7 days
Outcomes
Primary Outcomes
Hierarchical composite endpoint consisting of death, myocardial infarction, stroke, unstable angina hospitalization, heart failure hospitalization, urgent coronary revascularization or respiratory infections hospitalizations
Time Frame: 12 months
The primary objective will be analyzed using the win ratio approach comparing every participant of treatment group to every participant of control group to determine a winner
Secondary Outcomes
- Stent thrombosis(12 months)
- Heart failure hospitalizations(12 months)
- TIA (Transient ischemic attack)(12 months)
- Key Secondary End Point is a hierarchical outcome consisting only of cardiovascular death, myocardial infarction or stroke.(12 months)
- Myocardial infarction(12 months)
- Stroke(12 months)
- Cardiovascular mortality(12 months)
- Respiratory infections hospitalizations(12 months)
- Need for myocardial revascularization(12 months)
- COVID-19 hospitalizations(12 months)
- Total mortality(12 months)
- Unstable angina hospitalization(12 months)