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.

Condition	Intervention	Phase
Heart Disease Cardiovascular Disease	Drug: clarithromycin	Phase III

Further Study Details: 

Primary Outcomes: Composite consisting of: death regardless of cause; non-fatal AMI or; unstable angina pectoris whichever occurred first
Secondary Outcomes: Composite of: cardiovascular death; non-fatal AMI or; unstable angina pectoris whichever occurred first
Expected Total Enrollment:  4372

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.

Ages Eligible for Study:  18 Years   -   84 Years,  Genders Eligible for Study:  Both

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

Denmark
      Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen,  2100,  Denmark
      H:S Bispebjerg Hospital, Copenhagen,  2400,  Denmark
      H:S Rigshospitalet, Copenhagen,  2100,  Denmark
      H:S Frederiksberg Hospital, Frederiksberg,  2000,  Denmark
      H:S Hvidovre Hospital, Hvidovre,  2650,  Denmark
      H:S Amager Hospital, Copenhagen,  2300,  Denmark

Study chairs or principal investigators

Christian Jespersen, DMSc,  Study Chair,  Department of Cardiology Y, Bispebjerg Hospital, Bispebjerg Bakke 23, DK 2400 Copenhagen NV, Denmark.   
Christian Gluud, DMSc,  Principal Investigator,  Copenhagen Trial Unit, Center of Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK-2100 Copenhagen   

Study ID Numbers:  1997-08-DP-42-RKF-13 CLARICOR;; REC: KF01-076/99; DDPA: 2001-41-1496,; DMA: 2612-975
Last Updated:  August 1, 2005
Record first received:  July 20, 2005
ClinicalTrials.gov Identifier:  NCT00121550
Health Authority: Denmark: Danish Medicines Agency; Denmark: The Regional Committee on Biomedical Research Ethics
ClinicalTrials.gov processed this record on 2005-08-02