Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121550
Status:
COMPLETED
Last Update Posted:
2016-08-11
First Post:
2005-07-13
Brief Title:
The CLARICOR Trial Effect of Clarithromycin on Mortality and Morbidity in Patients With Ischemic Heart Disease
Sponsor:
Copenhagen Trial Unit Center for Clinical Intervention Research
Organization:
Copenhagen Trial Unit Center for Clinical Intervention Research
Study Overview
Official Title:
The Effect of Clarithromycin on Mortality and Morbidity in Patients With Ischemic Heart Disease - a Randomized Placebo Controlled Double Blinded Multicentre Clinical Trial
Status:
COMPLETED
Status Verified Date:
2016-08
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:
A growing body of evidence links Chlamydia pneumoniae to the progression of coronary heart disease The purpose of this study is to determine the positive and negative effect of 14 days treatment with clarithromycin 500 mg daily in patients already suffering from stable coronary heart disease The participants will be followed for at least two years after the treatment
Abbott Laboratories supplied Clarithromycin and placebo tablets
Abbott Laboratories supplied Clarithromycin and placebo tablets
Detailed Description:
Basic science suggests a fundamental role for inflammation in mediating all stages of coronary heart disease CHD and a large number of clinical studies have reported an association between markers of inflammation and CHD Consequently infectious agents have been proposed as promoters of atherosclerosis andor acute coronary syndrome ACS Many studies have suggested a relation between Chlamydia pneumoniae C pneumoniae infection and CHD and C pneumoniae has been demonstrated in atherosclerotic tissue
Macrolide antibiotics are effective in eradication of C pneumoniae from atherosclerotic plaques Two small trials showed significant beneficial effects of macrolides on cardiovascular morbidity in patients with ACS To corroborate and extend these findings we undertook a randomised placebo-controlled trial with clarithromycin in patients with stable CHD in order to test the hypothesis that intervention with a macrolide would reduce cardiovascular risk with regard to mortality and morbidity
Macrolide antibiotics are effective in eradication of C pneumoniae from atherosclerotic plaques Two small trials showed significant beneficial effects of macrolides on cardiovascular morbidity in patients with ACS To corroborate and extend these findings we undertook a randomised placebo-controlled trial with clarithromycin in patients with stable CHD in order to test the hypothesis that intervention with a macrolide would reduce cardiovascular risk with regard to mortality and morbidity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DMA 2612-975 | None | None | None |
| REC KF01-07699 | None | None | None |
| DDPA 2001-41-1496 | None | None | None |