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Home > "A" Clinical Trials Conditions > Azithromycin and Coronary Events Study (ACES)  Azithromycin and Coronary Events Study (ACES)
Azithromycin and Coronary Events Study (ACES)
For Condition: Coronary Disease,Heart Diseases,Myocardial Infarction,Cardiovascular Diseases
Status: No longer recruiting
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To determine whether treatment with azithromycin decreases the rate of coronary heart disease events among patients with stable documented coronary artery disease.
Details: 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 C. 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 will be contacted at one, three, and six weeks, and at three, six, nine, and twelve months. The patients will be 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 will be contacted every six months to determine the occurrence of outcomes. In addition, when available, computerized hospitalization and outpatient data will be reviewed. Outcome events will be classified using standardized algorithms. The relationship of antibody titer at baseline to the efficacy of azithromycin and outcome will be a secondary analysis. The primary analysis will be according to the intent-to-treat principle. In addition to the therapeutic trial a serologic follow-up substudy will be conducted on 25 percent of patients enrolled in the therapeutic trial. The subset of patients will be 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 is 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:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: Men and women over the age of 18 who have stable, documented coronary artery disease (CAD). Evidence of CAD is by any one of: history of MI; greater than 50% stenosis in any coronary artery; or history of coronary revascularization procedure.
Total Enrollment:
Location and Contact Information:
Overall Study Official:
J.Grayston, , University of Washington
Additional Information:
Study ID Numbers: 120;
Study Start Date: September 1998
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000617
Other Cardiovascular Diseases Studies:
1. ARISE - Aggressive Reduction of Inflammation Stops Events
2. Montreal Heart Attack Readjustment Trial (M-HART)
3. Aspirin-Myocardial Infarction Study (AMIS)
4. Trial of Aspirin and Vitamin E in Women (Women's Health Study - WHS)
5. Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE)
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Azithromycin and Coronary Events Study (ACES)
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