Azithromycin and Coronary Events Study (ACES)
Primary Purpose
Coronary Disease, Heart Diseases, Myocardial Infarction
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
azithromycin
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Disease
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000617
First Posted
October 27, 1999
Last Updated
November 4, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00000617
Brief Title
Azithromycin and Coronary Events Study (ACES)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2005
Overall Recruitment Status
Completed
Study Start Date
September 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease, Heart Diseases, Myocardial Infarction, Cardiovascular Diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
azithromycin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Grayston
Organizational Affiliation
University of Washington
12. IPD Sharing Statement
Citations:
PubMed Identifier
10839763
Citation
Jackson LA. Description and status of the azithromycin and coronary events study (ACES). J Infect Dis. 2000 Jun;181 Suppl 3:S579-81. doi: 10.1086/315628.
Results Reference
background
PubMed Identifier
15843674
Citation
Anderson JL. Infection, antibiotics, and atherothrombosis--end of the road or new beginnings? N Engl J Med. 2005 Apr 21;352(16):1706-9. doi: 10.1056/NEJMe058019. No abstract available.
Results Reference
background
PubMed Identifier
15843666
Citation
Grayston JT, Kronmal RA, Jackson LA, Parisi AF, Muhlestein JB, Cohen JD, Rogers WJ, Crouse JR, Borrowdale SL, Schron E, Knirsch C; ACES Investigators. Azithromycin for the secondary prevention of coronary events. N Engl J Med. 2005 Apr 21;352(16):1637-45. doi: 10.1056/NEJMoa043526.
Results Reference
background
Learn more about this trial
Azithromycin and Coronary Events Study (ACES)
We'll reach out to this number within 24 hrs