|
Azithromycin and Coronary Events Study (ACES) Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Azithromycin and Coronary Events Study (ACES) conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Azithromycin and Coronary Events Study (ACES) Clinical research trials and Azithromycin and Coronary Events Study (ACES) health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Azithromycin and Coronary Events Study (ACES). Azithromycin and Coronary Events Study (ACES) Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Azithromycin and Coronary Events Study (ACES) clinical trial. Subjects frequently get the best healthcare possible for their Azithromycin and Coronary Events Study (ACES) condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
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 Heart Diseases Studies:
1. Occluded Artery Trial (OAT)
2. Family Heart Study - Subclinical Atherosclerosis Network (FHS-SCAN)
3. Coronary Drug Project
4. Multi-Ethnic Study of Atherosclerosis (MESA)
5. Systolic Hypertension in the Elderly Program (SHEP)
Related Studies:
Other Heart Diseases Clinical Trials
Other Clinical Trials
Other Clinical Trials
Azithromycin and Coronary Events Study (ACES)
|
|
|
|
|
|
|
|
