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The CLARICOR Trial: Effect of Clarithromycin on Mortality and Morbidity in Patients With Ischemic Heart Disease

The Effect of Clarithromycin on Mortality and Morbidity in Patients With Ischemic Heart Disease - a Randomized, Placebo Controlled, Double Blinded, Multicentre, Clinical Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00121550
Enrollment
4372
Registered
2005-07-21
Start date
1999-10-31
Completion date
2002-09-30
Last updated
2016-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Heart Disease

Keywords

Coronary heart disease, Clarithromycin, Macrolides, Cardiovascular mortality, Chlamydia pneumoniae

Brief summary

A growing body of evidence links Chlamydia pneumoniae to the progression of coronary heart disease. The purpose of this study is to determine the positive and negative effect of 14 days treatment with clarithromycin 500 mg daily in patients already suffering from stable coronary heart disease. The participants will be followed for at least two years after the treatment. Abbott Laboratories supplied Clarithromycin and placebo tablets.

Detailed description

Basic science suggests a fundamental role for inflammation in mediating all stages of coronary heart disease (CHD), and a large number of clinical studies have reported an association between markers of inflammation and CHD. Consequently, infectious agents have been proposed as promoters of atherosclerosis and/or acute coronary syndrome (ACS). Many studies have suggested a relation between Chlamydia pneumoniae (C. pneumoniae) infection and CHD, and C. pneumoniae has been demonstrated in atherosclerotic tissue. Macrolide antibiotics are effective in eradication of C. pneumoniae from atherosclerotic plaques. Two small trials showed significant beneficial effects of macrolides on cardiovascular morbidity in patients with ACS. To corroborate and extend these findings, we undertook a randomised, placebo-controlled trial with clarithromycin in patients with stable CHD in order to test the hypothesis that intervention with a macrolide would reduce cardiovascular risk with regard to mortality and morbidity.

Interventions

DRUGclarithromycin

Sponsors

Danish Heart Foundation
CollaboratorOTHER
Copenhagen Hospital Corporation
CollaboratorOTHER
The Danish Medical Research Council
CollaboratorOTHER
The 1991 Pharmacy Foundation
CollaboratorOTHER
Abbott
CollaboratorINDUSTRY
Copenhagen Trial Unit, Center for Clinical Intervention Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
No

Inclusion criteria

* patients aged 18 to 85 years and * previous acute myocardial infarction (AMI) or * previous or present angina pectoris and * signed informed concent

Exclusion criteria

* AMI or unstable angina pectoris within the last three months * revascularisation (PTCA or CABG) within the preceding six months * severe heart failure (New York Heart Association (NYHA) functional class IV) * known impaired renal or hepatic function * active malignancy * intolerance to macrolides * treatment with methylxanthines, carbamazepine, cisapride, astemizole, terfenadine, or coumarin anticoagulants * earlier inclusion in the CLARICOR Trial or participation in another drug trial within four weeks * participation in other clinical trials within one month before this trial * individuals incapable of managing own affairs or not able to sign written consent * lack of written consent * women of childbearing age not using reliable contraceptives * breast feeding women

Design outcomes

Primary

MeasureTime frame
Composite consisting of: death regardless of cause
non-fatal AMI or
unstable angina pectoris whichever occurred first

Secondary

MeasureTime frame
Composite of: cardiovascular death
non-fatal AMI or
unstable angina pectoris whichever occurred first

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 12, 2026