The CLARICOR Trial: Effect of Clarithromycin on Mortality and Morbidity in Patients With Ischemic Heart Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Heart Disease, Cardiovascular Disease

Intervention / Treatment
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* Drug: clarithromycin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clarithromycin<br>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. | Drug: clarithromycin<br> <br> |
| Placebo Comparator: Placebo<br>Placebo comparator | Drug: clarithromycin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite consisting of: death regardless of cause |  |  | 
| non-fatal AMI or |  |  | 
| unstable angina pectoris whichever occurred first |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of: cardiovascular death |  |  | 
| non-fatal AMI or |  |  | 
| unstable angina pectoris whichever occurred first |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary heart disease, Clarithromycin, Macrolides, Cardiovascular mortality, Chlamydia pneumoniae