Randomised placebo controlled multicentre trial to assess short term clarithromycin for patients with stable coronary heart disease: CLARICOR trial. CLARICOR trial

Christian M Jespersen, Bodil Als-Nielsen, Morten Damgaard, Jørgen Fischer Hansen, Stig Hansen, Olav H Helø, Per Hildebrandt, Jørgen Hilden, Gorm B Jensen, Jens Kastrup, Hans Jørn Jepsen Kolmos, Erik Kjøller, Inga Lind, Henrik Nielsen, Lars Petersen, Christian Gluud, CLARICOR Trial Group

140 Citationer (Scopus)

Abstract

OBJECTIVE: To determine if the macrolide clarithromycin affects mortality and cardiovascular morbidity in patients with stable coronary heart disease. DESIGN: Centrally randomised multicentre trial. All parties at all stages were blinded. Analyses were by intention to treat. SETTING: Five Copenhagen University cardiology departments and a coordinating centre. PARTICIPANTS: 13,702 patients aged 18 to 85 years who had a discharge diagnosis of myocardial infarction or angina pectoris in 1993-9 and alive in August 1999 were invited by letter; 4373 were randomised. INTERVENTIONS: Two weeks' treatment with clarithromycin 500 mg/day or matching placebo. MAIN OUTCOME MEASURES: Primary outcome: composite of all cause mortality, myocardial infarction, or unstable angina pectoris during three years' follow-up. Secondary outcome: composite of cardiovascular mortality, myocardial infarction, or unstable angina pectoris. The outcomes were obtained from Danish registers and were blindly assessed by the event committee. RESULTS: 2172 participants were randomised to clarithromycin and 2201 to placebo. We found no significant effects of clarithromycin on the primary outcome (hazard ratio 1.15, 95% confidence interval 0.99 to 1.34) or secondary outcome (1.17, 0.98 to 1.40). Mortality was significantly higher in the clarithromycin arm (1.27, 1.03 to 1.54; P = 0.03) as a result of significantly higher cardiovascular mortality (1.45, 1.09 to 1.92; P = 0.01). CONCLUSIONS: Short term clarithromycin in patients with stable coronary heart disease may cause significantly higher cardiovascular mortality. The long term safety of clarithromycin in patients with stable ischaemic heart disease should be examined. Trial registration ClinicalTrials.gov NCT00121550. Erratum in: BMJ. 2006 Jan 21;332(7534):151. Comment in: Evid Based Cardiovasc Med. 2006 Jun;10(2):147-8. Republished in: Ugeskr Laeger. 2007 Feb 5;169(6):497-9.
OriginalsprogEngelsk
TidsskriftB M J
Vol/bind332
Udgave nummer7532
Sider (fra-til)22-7
Antal sider6
ISSN0959-8146
DOI
StatusUdgivet - 2006

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