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Coronary Artery DiseasePhase 2/3NCT00371098

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

A Phase 2/3 study testing Influenza vaccination: Influvac (SolvayPharma) in people with Coronary Artery Disease, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Influenza vaccination: Influvac (SolvayPharma)
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
658 participants
Where
1 sitePoland
Study dates
Oct 2004to Dec 2005
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • 1st Dept. of Coronary Artery Disease, Institute of Cardiology

    Warsaw, 04-628

Other trials in Poland

About this study

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

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.

Read the 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.

References:

  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.
Being tested
Influenza vaccination: Influvac (SolvayPharma), placebo influenza vaccine
Keywords
influenza vaccination, coronary artery disease, prevention, acute coronary syndromes
Medical subject headings
Coronary Artery Disease, Influenza, Human, Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Influenza vaccination: Influvac (SolvayPharma)Biological

  • placebo influenza vaccineBiological

Study groups in NCT00371098
Study groupRoleWhat they receive
active vaccineExperimentalpatients received active influenza vaccine for season 2004/2005
Receives: Biological: Influenza vaccination: Influvac (SolvayPharma)
placebo vaccinePlacebo comparatorpatients received placebo influenza vaccine for season 2004/2005 containing all vaccine compounds except viral antigens
Receives: Biological: placebo influenza vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cardiovascular death

    Measured: 12 months

Secondary outcomes (2)
  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).

    Measured: 12 month

  2. Second composite study end point was Ischemic Event (MACE or hospitalization for ischemia).

    Measured: 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2006 (estimated)
  2. Study startOct 2004
  3. Study completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
658 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00371098
Sponsor's protocol ID
IK-NP-0021-2/812/04
Other IDs
2 P05B 016 27
Status last verified
Oct 2007
First submitted
31 Aug 2006
Last updated
23 Oct 2007
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 18187561

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Influenza vaccination: Influvac (SolvayPharma) in people with Coronary Artery Disease, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cardiovascular death (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00371098, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2007.

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