title: Randomised placebo controlled multicentre trial to assess short term clarithromycin for patients with stable coronary heart disease: CLARICOR trial.
abstract: OBJECTIVE
  To determine if the macrolide clarithromycin affects mortality and cardiovascular morbidity in patients with stable coronary heart disease.
  
  
  METHODS
  Centrally randomised multicentre trial. All parties at all stages were blinded. Analyses were by intention to treat.
  
  
  METHODS
  Five Copenhagen University cardiology departments and a coordinating centre.
  
  
  METHODS
  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.
  
  
  METHODS
  Two weeks' treatment with clarithromycin 500 mg/day or matching placebo.
  
  
  METHODS
  
  
  
  METHODS
  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.
authors.affiliation: Bispebjerg Hospital, Copenhagen University Hospital, Department of Cardiology Y, Bispebjerg Bakke 23, DK-2400 Copenhagen, Denmark. cmj01@bbh.hosp.dk
authors.forename: Christian M
authors.initials: CM
authors.lastname: Jespersen
authors.forename: Bodil
authors.initials: B
authors.lastname: Als-Nielsen
authors.forename: Morten
authors.initials: M
authors.lastname: Damgaard
authors.forename: Jørgen Fischer
authors.initials: JF
authors.lastname: Hansen
authors.forename: Stig
authors.initials: S
authors.lastname: Hansen
authors.forename: Olav H
authors.initials: OH
authors.lastname: Helø
authors.forename: Per
authors.initials: P
authors.lastname: Hildebrandt
authors.forename: Jørgen
authors.initials: J
authors.lastname: Hilden
authors.forename: Gorm B
authors.initials: GB
authors.lastname: Jensen
authors.forename: Jens
authors.initials: J
authors.lastname: Kastrup
authors.forename: Hans Jørn
authors.initials: HJ
authors.lastname: Kolmos
authors.forename: Erik
authors.initials: E
authors.lastname: Kjøller
authors.forename: Inga
authors.initials: I
authors.lastname: Lind
authors.forename: Henrik
authors.initials: H
authors.lastname: Nielsen
authors.forename: Lars
authors.initials: L
authors.lastname: Petersen
authors.forename: Christian
authors.initials: C
authors.lastname: Gluud
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000787:Angina Pectoris / Q000188:drug therapy*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D023521:Chlamydophila Infections / Q000188:drug therapy; D016993:Chlamydophila pneumoniae; D017291:Clarithromycin / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D017291:Clarithromycin