Trial | NCT00121550  Report issue

Title

The CLARICOR Trial: Effect of Clarithromycin on Mortality and Morbidity in Patients With Ischemic Heart Disease
The Effect of Clarithromycin on Mortality and Morbidity in Patients With Ischemic Heart Disease - a Randomized, Placebo Controlled, Double Blinded, Multicentre, Clinical Trial

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    4372
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.
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 and/or 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.
Study Started
Oct 31
1999
Primary Completion
Apr 30
2000
Study Completion
Sep 30
2002
Last Update
Aug 11
2016
Estimate

Drug clarithromycin

Clarithromycin Experimental

Clarithromycin is a lipophilic semi-synthetic macrolide antibiotic. The lipophilic nature of the drug allows it to easily penetrate into body fluids and tissues and accumulate intracellularly. Side effects are few, apart from trivial gastrointestinal complaints, and severe side effects are rarely observed during standard treatment.

Placebo Placebo Comparator

Placebo comparator

Criteria 

Inclusion Criteria:

patients aged 18 to 85 years and
previous acute myocardial infarction (AMI) or
previous or present angina pectoris and
signed informed concent

Exclusion Criteria:

AMI or unstable angina pectoris within the last three months
revascularisation (PTCA or CABG) within the preceding six months
severe heart failure (New York Heart Association (NYHA) functional class IV)
known impaired renal or hepatic function
active malignancy
intolerance to macrolides
treatment with methylxanthines, carbamazepine, cisapride, astemizole, terfenadine, or coumarin anticoagulants
earlier inclusion in the CLARICOR Trial or participation in another drug trial within four weeks
participation in other clinical trials within one month before this trial
individuals incapable of managing own affairs or not able to sign written consent
lack of written consent
women of childbearing age not using reliable contraceptives
breast feeding women
No Results Posted