Trial | NCT00607178  Report issue

Title

The Efficacy of Influenza Vaccine in Reducing Cardiovascular Events in Patients With Coronary Artery Diseases
Randomized, Single-Blind, Placebo-Controlled Study of Influenza Vaccine in Preventing Cardiovascular Events in Post-Myocardial Infarction Patients and in Those With Stable Angina Pectoris

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    300
Influenza vaccine reduces the cardiovascular events in post-myocardial infarction (MI) patients and in those with stable angina (SA).
A connection between infectious processes and atherosclerosis is repeatedly reported [1]. Acute respiratory infection was found to be associated with myocardial infarction (MI) [2,3] and a number of epidemiological studies found that mortality attributable to cardiovascular diseases is increased during influenza epidemics [4]. Naghavi et al [5] in a case-control study of patients with coronary artery disease (CAD) found that vaccination against influenza was negatively associated with the development of new MI during the same influenza season. While some clinical trials found influenza vaccine effective in secondary prevention of cardiovascular adverse events [6,7], a large trial [8] failed to approve such an efficacy. Furthermore, a recent review of published trials on the subject concluded that frailty selection bias and use of non-specific endpoints such as all cause mortality have led cohort studies to greatly exaggerate vaccine benefits and that the remaining evidence base is currently insufficient to indicate the magnitude of the mortality benefit of the vaccination program [9].

This study aims to assess the efficacy of vaccine in secondary prevention of cardiovascular events in MI and stable angina (SA) patients using specific endpoints including reliable quantitative tools.
Study Started
Jan 31
2008
Primary Completion
Sep 30
2008
Study Completion
Sep 30
2008
Last Update
Jan 22
2009
Estimate

Biological influenza vaccine

Intramuscular injection of one 0.5-mL dose of influenza vaccine

  • Other names: 2006-2007 vaccination campaign of Influvac (SolvayPharma)

Biological placebo for influenza vaccine

Intramuscular injection of one 0.5-mL dose of placebo for influenza vaccine

Influenza vaccine Experimental

Enrolled patients who are randomly assigned to receive influenza vaccine

Placebo Placebo Comparator

Enrolled patients who are randomly assigned to receive placebo of influenza vaccine

Criteria 

Inclusion Criteria:

Patients with the diagnosis of acute, evolving or recent MI (after recovered the acute phase) as defined by:

Typical rise and gradual fall (troponin) or more rapid rise and fall (CK-MB) of biochemical markers of myocardial necrosis with at least one of the following:

Ischemic symptoms
Development of pathologic Qwaves on the ECG
ECG changes indicative of ischemia (ST segment elevation or depression); OR
Coronary artery intervention (e.g., coronary angioplasty).
Pathologic findings of an acute MI [12]
Patients with stable angina pectoris and documented coronary artery stenosis (angiography).

Exclusion Criteria:

Any acute disease
Chronic liver or kidney diseases
Conditions accompanied by immunosuppression (like organ transplantation, HIV)
Diagnosed malignancy
Incubation with influenza vaccine within the past 5 years
Any psychological disease that interferes with regular follow-up
Congestive heart failure (Killip class IV)
Unstable angina, and contradictions of vaccine incubation (like egg allergy).
No Results Posted