Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000617
Status:
COMPLETED
Last Update Posted:
2016-11-06
First Post:
1999-10-27
Brief Title:
Azithromycin and Coronary Events Study ACES
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| M01RR000645-34 | NIH | None | httpsreporternihgovquickSearchM01RR000645-34 |
| M01RR007122-13 | NIH | None | None |
| M01RR000048-44 | NIH | None | None |