Azithromycin and Coronary Events Study (ACES)

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00000617
First received: October 27, 1999
Last updated: June 23, 2005
Last verified: May 2005
  Purpose

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


Condition Intervention Phase
Coronary Disease
Heart Diseases
Myocardial Infarction
Cardiovascular Diseases
Drug: azithromycin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 1998
Estimated Study Completion Date: January 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Men and women over the age of 18 who have stable, documented coronary artery disease (CAD). Evidence of CAD was by any one of: history of MI; greater than 50% stenosis in any coronary artery; or history of coronary revascularization procedure.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000617

Sponsors and Collaborators
Investigators
Investigator: J. Grayston University of Washington
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00000617     History of Changes
Other Study ID Numbers: 120
Study First Received: October 27, 1999
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Coronary Disease
Heart Diseases
Infarction
Myocardial Infarction
Arterial Occlusive Diseases
Arteriosclerosis
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014