Randomised placebo controlled multicentre trial to assess short term clarithromycin for patients with stable coronary heart disease: 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 Kolmos; Erik Kjøller; Inga Lind; Henrik Nielsen; Lars Petersen; Christian Gluud; CLARICOR Trial Group

doi:10.1136/bmj.38666.653600.55

Randomised placebo controlled multicentre trial to assess short term clarithromycin for patients with stable coronary heart disease: 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 Kolmos, Erik Kjøller, Inga Lind, Henrik Nielsen, Lars Petersen, Christian Gluud, CLARICOR Trial Group

116 Citations (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.

Original language	English
Journal	BMJ - British Medical Journal - Clinical Research Edition
Volume	332
Issue number	7532
Pages (from-to)	22-7
Number of pages	5
ISSN	0959-8138
DOIs	https://doi.org/10.1136/bmj.38666.653600.55
Publication status	Published - 2005

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Jespersen, C. M., Als-Nielsen, B., Damgaard, M., Hansen, J. F., Hansen, S., Helø, O. H., Hildebrandt, P., Hilden, J., Jensen, G. B., Kastrup, J., Kolmos, H. J., Kjøller, E., Lind, I., Nielsen, H., Petersen, L., Gluud, C., & CLARICOR Trial Group (2005). Randomised placebo controlled multicentre trial to assess short term clarithromycin for patients with stable coronary heart disease: CLARICOR trial. BMJ - British Medical Journal - Clinical Research Edition, 332(7532), 22-7. https://doi.org/10.1136/bmj.38666.653600.55

Randomised placebo controlled multicentre trial to assess short term clarithromycin for patients with stable coronary heart disease: CLARICOR trial. / Jespersen, Christian M; Als-Nielsen, Bodil; Damgaard, Morten et al.

In: BMJ - British Medical Journal - Clinical Research Edition, Vol. 332, No. 7532, 2005, p. 22-7.

Research output: Contribution to journal › Journal article › Research › peer-review

Jespersen, CM, Als-Nielsen, B, Damgaard, M, Hansen, JF, Hansen, S, Helø, OH, Hildebrandt, P, Hilden, J, Jensen, GB, Kastrup, J, Kolmos, HJ, Kjøller, E, Lind, I, Nielsen, H, Petersen, L, Gluud, C & CLARICOR Trial Group 2005, 'Randomised placebo controlled multicentre trial to assess short term clarithromycin for patients with stable coronary heart disease: CLARICOR trial', BMJ - British Medical Journal - Clinical Research Edition, vol. 332, no. 7532, pp. 22-7. https://doi.org/10.1136/bmj.38666.653600.55

@article{4c05cc509d4b11debc73000ea68e967b,

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. 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.",

author = "Jespersen, {Christian M} and Bodil Als-Nielsen and Morten Damgaard and Hansen, {J{\o}rgen Fischer} and Stig Hansen and Hel{\o}, {Olav H} and Per Hildebrandt and J{\o}rgen Hilden and Jensen, {Gorm B} and Jens Kastrup and Kolmos, {Hans J{\o}rn} and Erik Kj{\o}ller and Inga Lind and Henrik Nielsen and Lars Petersen and Christian Gluud and {CLARICOR Trial Group}",

note = "Keywords: Adolescent; Adult; Aged; Aged, 80 and over; Angina Pectoris; Anti-Bacterial Agents; Chlamydophila Infections; Chlamydophila pneumoniae; Clarithromycin; Humans; Middle Aged; Myocardial Infarction; Treatment Outcome",

year = "2005",

doi = "10.1136/bmj.38666.653600.55",

language = "English",

volume = "332",

pages = "22--7",

journal = "B M J (Clinical Research Edition)",

issn = "0959-8138",

publisher = "B M J Group",

number = "7532",

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TY - JOUR

T1 - Randomised placebo controlled multicentre trial to assess short term clarithromycin for patients with stable coronary heart disease: CLARICOR trial

AU - Jespersen, Christian M

AU - Als-Nielsen, Bodil

AU - Damgaard, Morten

AU - Hansen, Jørgen Fischer

AU - Hansen, Stig

AU - Helø, Olav H

AU - Hildebrandt, Per

AU - Hilden, Jørgen

AU - Jensen, Gorm B

AU - Kastrup, Jens

AU - Kolmos, Hans Jørn

AU - Kjøller, Erik

AU - Lind, Inga

AU - Nielsen, Henrik

AU - Petersen, Lars

AU - Gluud, Christian

AU - CLARICOR Trial Group

N1 - Keywords: Adolescent; Adult; Aged; Aged, 80 and over; Angina Pectoris; Anti-Bacterial Agents; Chlamydophila Infections; Chlamydophila pneumoniae; Clarithromycin; Humans; Middle Aged; Myocardial Infarction; Treatment Outcome

PY - 2005

Y1 - 2005

N2 - 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.

AB - 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.

U2 - 10.1136/bmj.38666.653600.55

DO - 10.1136/bmj.38666.653600.55

M3 - Journal article

C2 - 16339220

SN - 0959-8138

VL - 332

SP - 22

EP - 27

JO - B M J (Clinical Research Edition)

JF - B M J (Clinical Research Edition)

IS - 7532

ER -

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

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