Azithromycin and Coronary Events Study (ACES)
Condition: Coronary Disease; Heart Diseases; Myocardial Infarction; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases; Myocardial Infarction; Coronary Disease; Infarction
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine whether treatment with azithromycin decreases the rate of coronary heart disease
      events among patients with stable documented coronary artery disease.
    

Detailed description: 
      BACKGROUND:

      Cumulative evidence from past studies supports but does not prove a causal association
      between Chlamydia pneumoniae infection and development or progression of atherosclerotic
      cardiovascular disease. Evidence supporting an association raises the question of whether a
      causal effect of Chlamydia pneumonia infection, if present, may be ameliorated by antibiotic
      treatment, resulting in decreased CHD outcomes. The ACES is a randomized, double-blind,
      placebo-controlled study to determine whether treatment with azithromycin decreases the rate
      of coronary heart disease events among patients with stable documented coronary artery
      disease.

      DESIGN NARRATIVE:

      A randomized, double-blind, multicenter trial of azithromycin versus placebo among adults
      with documented prevalent coronary artery disease. Patients were enrolled over an 18-month
      period from a total of 28 centers. Following enrollment, an electrocardiogram was obtained,
      and patients with a prolonged QT interval were excluded. Eligible patients were then
      randomized to receive either placebo or azithromycin 600 milligrams orally once a week for a
      year. At the time of enrollment, a blood sample was obtained for C. pneumoniae antibody
      testing. Patients were contacted at one, three, and six weeks, and at three, six, nine, and
      twelve months. The patients were followed for a mean of four years for the composite primary
      outcome of coronary heart disease death, non-fatal myocardial infarction, hospitalization for
      unstable angina, and requirement for coronary artery bypass grafting or percutaneous
      revascularization. After the first year of the study, each patient was contacted every six
      months to determine the occurrence of outcomes. In addition, when available, computerized
      hospitalization and outpatient data were reviewed. Outcome events were classified using
      standardized algorithms. The relationship of antibody titer at baseline to the efficacy of
      azithromycin and outcome was a secondary analysis. The primary analysis was according to the
      intent-to-treat principle.

      In addition to the therapeutic trial a serologic follow-up substudy was conducted on 25
      percent of patients enrolled in the therapeutic trial. The subset of patients were randomized
      to obtain blood samples at three and six months, one and two years, and at the end of the
      study for serologies. The purpose of the substudy was to determine the effect of azithromycin
      on serologic titers to C. pneumoniae and to evaluate whether the occurrence of coronary heart
      disease events is associated with a change in antibody titer.

      Protocol planning will take place for the first six months of the trial, followed by one and
      a half years of patient enrollment. Patient followup continues for three years after the
      recruitment period and the final six months will be a close out and analysis phase.

      The study completion date listed in this record was obtained from the "Completed Date"
      entered in the Query View Report System (QVR).
    

Intervention name(s): azithromycin
Intervention type(s): Drug
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Masking: Double
Primary purpose: Prevention