Influenza Vaccination in Prevention From Acute Coronary Events in Coronary Artery Disease - FLUCAD Study
Prospective, Randomized, Double-Blind Placebo Controlled Study on Influenza Vaccination in Prevention From Coronary Events in Patients With Coronary Artery Disease Confirmed by Angiography
2 other identifiers
interventional
658
1 country
1
Brief Summary
Background: Influenza vaccination is recommended in patients (pts) with cardiovascular disease, however there is a shortage of clinical studies proving its protective effect on clinical course of coronary artery disease (CAD). The aim of the study was to evaluate the effect of influenza vaccination on the incidence of coronary events in pts with CAD confirmed by coronary angiography.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 coronary-artery-disease
Started Oct 2004
Shorter than P25 for phase_2 coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 31, 2006
CompletedFirst Posted
Study publicly available on registry
September 1, 2006
CompletedOctober 23, 2007
October 1, 2007
August 31, 2006
October 21, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
cardiovascular death
12 months
Secondary Outcomes (2)
First composite study end point was Major Adverse Cardiac Event (MACE). MACE was combined of: cardiovascular death, acute myocardial infarction (MI), coronary revascularization (PCI or coronary bypass).
12 month
Second composite study end point was Ischemic Event (MACE or hospitalization for ischemia).
12 month
Study Arms (2)
active vaccine
EXPERIMENTALpatients received active influenza vaccine for season 2004/2005
placebo vaccine
PLACEBO COMPARATORpatients received placebo influenza vaccine for season 2004/2005 containing all vaccine compounds except viral antigens
Interventions
Eligibility Criteria
You may qualify if:
- Patients, aged 30-80 years, with CAD confirmed by coronarography with at least 50% stenosis of one large epicardial coronary artery.
You may not qualify if:
- planned cardiovascular surgery within 6 months, congestive heart failure NYHA III/IV, evolving renal failure, neoplastic disease, psycho-organic disorder or any factor impeding follow-up, contraindication to vaccination.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
1st Dept. of Coronary Artery Disease, Institute of Cardiology
Warsaw, 04-628, Poland
Related Publications (1)
Ciszewski A, Bilinska ZT, Brydak LB, Kepka C, Kruk M, Romanowska M, Ksiezycka E, Przyluski J, Piotrowski W, Maczynska R, Ruzyllo W. Influenza vaccination in secondary prevention from coronary ischaemic events in coronary artery disease: FLUCAD study. Eur Heart J. 2008 Jun;29(11):1350-8. doi: 10.1093/eurheartj/ehm581. Epub 2008 Jan 10.
PMID: 18187561RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrzej Ciszewski, MD, PhD
1st Dept of Coronary Artery Disease, Institute of Cardiology, Warsaw, Poland
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 31, 2006
First Posted
September 1, 2006
Study Start
October 1, 2004
Study Completion
December 1, 2005
Last Updated
October 23, 2007
Record last verified: 2007-10