Ignite Creation Date:
2024-05-06 @ 1:23 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04001504
Status:
COMPLETED
Last Update Posted:
2022-08-31
First Post:
2019-06-26
Brief Title:
Vaccination Against Influenza to Prevent Cardiovascular Events After Acute Coronary Syndromes
Sponsor:
Hospital Israelita Albert Einstein
Organization:
Hospital Israelita Albert Einstein
Study Overview
Official Title:
Evaluation of the Effectiveness of Double Dose Influenza Vaccination to Reduce Major Cardiovascular Events After an Acute Coronary Syndrome
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
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:
VIP-ACS
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 11 allocation blind assessment of clinical outcomes and intention-to-treat analysis clinical trial to determine whether increased dosesdouble 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 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?:
False
Is an FDA AA801 Violation?:
None