Randomised placebo controlled multicentre trial to assess short term clarithromycin for patients with stable coronary heart disease: CLARICOR trial.
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.
Jespersen
Christian M
CM
Bispebjerg Hospital, Copenhagen University Hospital, Department of Cardiology Y, Bispebjerg Bakke 23, DK-2400 Copenhagen, Denmark. cmj01@bbh.hosp.dk
Als-Nielsen
Bodil
B
Damgaard
Morten
M
Hansen
Jørgen Fischer
JF
Hansen
Stig
S
Helø
Olav H
OH
Hildebrandt
Per
P
Hilden
Jørgen
J
Jensen
Gorm B
GB
Kastrup
Jens
J
Kolmos
Hans Jørn
HJ
Kjøller
Erik
E
Lind
Inga
I
Nielsen
Henrik
H
Petersen
Lars
L
Gluud
Christian
C
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
D000900:Anti-Bacterial Agents; D017291:Clarithromycin