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Influenza Vaccination in Prevention From Acute Coronary Events in Coronary Artery Disease - FLUCAD Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00371098
Recruitment Status : Completed
First Posted : September 1, 2006
Last Update Posted : October 23, 2007
Solvay Pharmaceuticals
Information provided by:
Institute of Cardiology, Warsaw, Poland

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Biological: Influenza vaccination: Influvac (SolvayPharma) Biological: placebo influenza vaccine Phase 2 Phase 3

Detailed Description:

A possible relation between influenza and higher mortality from cardiovascular problems was first noticed in early nineteen hundreds, after epidemics in Europe and United States were discovered (1). In the last decade many studies implicating an important role of inflammation and infection (Herpes virus, Chlamydia pneumoniae, Helicobacter pylori) in development and progression of atherosclerosis (2,3), and markers of inflammation like: hs-CRP, fibrinogen, have become new independent cardiovascular risk factors (4).

Many general physicians now recommend influenza vaccination in patients with coronary artery disease (CAD) despite shortage of studies proving its protective effect on clinical course of CAD. In literature we found only a few reports exploring the hypothesis that influenza vaccination might reduce the incidence of myocardial infarction (MI) and acute coronary syndromes (ACS).

Naghavi et all. in retrospective, case- control study of 218 patients with chronic coronary disease reported that influenza vaccination was strongly associated with freedom from new MI during the same influenza season. (OR 0.33, 95% CI 0.13 to0.82, p=0.017) (5). Gurfinkiel et all. evaluated in prospective, single- blind Fluvacs study that preventive impact of vaccination on subsequent ischemic events at 6 months follow-up. Study group consisted of 301 patients after coronary angioplasty (PCI). The first primary outcome- cardiovascular death occurred in 2% in vaccine group compared with 8% in the control group (p=0.01) and triple composite end point (death, myocardial infarction and hospitalization from ischemia occurred in 11% in vaccine group vs. 23% in controls (p=0.0009) (6). In the contrary, Jackson et all. in largest study of 1378 survivors of first MI, in long (median 2.3 year) follow-up didn't find the benefit of influenza vaccine on the protection against recurrent coronary events (7).

The aim of our study is to evaluate the influence of influenza vaccination on the incidence of cardiac events (cardiovascular death, myocardial infarction, acute coronary syndromes, coronary revascularization and hospitalizations from ischemia) in patients with angiographically confirmed coronary disease.


  1. Collins SD. Excess mortality from causes other that influenza and pneumonia during influenza epidemics. Public Health Rep. 1932;47:2159-80.
  2. Sorlie PD, Adam E, Melnick SL, et al. Cytomegalovirus/herpesvirus and carotid atherosclerosis: the ARIC Study. J Med Virol. 1994;42:33-37.
  3. Zhou YF, Wanishsawad C, Epstein SE. Chlamydia pneumonia-induced transaction of cytomegalovirus: potential synergy of infectious agents in the pathogenesis of atherosclerosis. J Am Coll Cardiol. 1999;33(suppl A):260A.
  4. Toss H, Lindahl B, Siegbahn A, Wallentin L. (Frisc study group). Prognostic Influence of Increased Fibrinogen and C- reactive Protein Levels in Unstable Coronary Artery Disease. Circulation 1997; 96: 4304- 4210.
  5. Naghavi M., Barlas Z., Siadaty S., Nagiub S., Madjid M., Casscells W.: Association of influenza vaccination and reduced risk of myocardial infarction Circulation 2000; 102:3039-3045.
  6. Gurfinkel E.P., Leon de la Fuente R., Mendiz O., Mautner B. For the FLUVACS Study Group: Influenza vaccine pilot study in acute coronary syndromes and planned percutaneous coronary interventions. The FLU vaccination acute coronary syndromes (FLUVACS) Study. Circulation 2002;105:2143-2147.
  7. Jackson L.A., Heckbert S.R., Psaty B.M., Malais D., Barlow W.E., Thompson W.W. Vaccine Safety Datalink Study Group: Influenza vaccination is not associated with a reduction in the risk of recurrent coronary events. Am. J. Epidemiol. 2002; 156: 634-40.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 658 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prospective, Randomized, Double-Blind Placebo Controlled Study on Influenza Vaccination in Prevention From Coronary Events in Patients With Coronary Artery Disease Confirmed by Angiography
Study Start Date : October 2004
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: active vaccine
patients received active influenza vaccine for season 2004/2005
Biological: Influenza vaccination: Influvac (SolvayPharma)
Placebo Comparator: placebo vaccine
patients received placebo influenza vaccine for season 2004/2005 containing all vaccine compounds except viral antigens
Biological: placebo influenza vaccine

Primary Outcome Measures :
  1. cardiovascular death [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 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). [ Time Frame: 12 month ]
  2. Second composite study end point was Ischemic Event (MACE or hospitalization for ischemia). [ Time Frame: 12 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients, aged 30-80 years, with CAD confirmed by coronarography with at least 50% stenosis of one large epicardial coronary artery.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00371098

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1st Dept. of Coronary Artery Disease, Institute of Cardiology
Warsaw, Poland, 04-628
Sponsors and Collaborators
Institute of Cardiology, Warsaw, Poland
Solvay Pharmaceuticals
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Principal Investigator: Andrzej Ciszewski, MD, PhD 1st Dept of Coronary Artery Disease, Institute of Cardiology, Warsaw, Poland

Additional Information:
Publications of Results:
Layout table for additonal information Identifier: NCT00371098     History of Changes
Other Study ID Numbers: IK-NP-0021-2/812/04
2 P05B 016 27
First Posted: September 1, 2006    Key Record Dates
Last Update Posted: October 23, 2007
Last Verified: October 2007

Keywords provided by Institute of Cardiology, Warsaw, Poland:
influenza vaccination
coronary artery disease
acute coronary syndromes

Additional relevant MeSH terms:
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Influenza, Human
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Immunologic Factors
Physiological Effects of Drugs