Intervention with Clarithromycin in Patients with Stable Coronary Heart Disease

Abstract

<i>Background:</i> There is a growing body of evidence linking <i>Chlamydia pneumoniae</i> to the progression of coronary heart disease. Smaller studies have indicated that intervention with macrolide antibiotics might reduce coronary events in patients with cardiovascular diseases. <i>Objective:</i> To describe the design of a large-scale intervention study on the effects of a macrolide antibiotic on coronary events in patients with stable coronary heart disease (documented myocardial infarction and/or angina pectoris). <i>Methods: </i>This study is a double-blind, randomised, placebo-controlled, multicentre study with parallel groups. Patients are randomised to 14 days of treatment with clarithromycin (500 mg, once daily) or matching placebo. The follow-up period is 2 years, and the primary end point is a composite end point of death, non-fatal myocardial infarction or unstable angina pectoris, whichever occurs first. Recruitment began in October 1999 and will be completed in 2000. In total, 4,600 patients will be randomised. <i>Prospectives:</i> The study is powered to detect a reduction in coronary events of 20%. Also, the study will examine the question of whether the presence of a <i>C. pneumoniae</i> antibody titre is associated with a significantly increased risk of future coronary events. Finally, in the case of a significant outcome, it will be possible to test whether the effect is restricted to patients with <i>C. pneumoniae</i> antibodies only, or to a universal effect without any coherence to <i>C. pneumoniae</i> antibodies.