The CLARICOR Trial: Effect of Clarithromycin on Mortality and Morbidity in Patients With Ischemic Heart Disease
Information source: Copenhagen Trial Unit, Center for Clinical Intervention Research
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Disease; Cardiovascular Disease
Intervention: clarithromycin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Copenhagen Trial Unit, Center for Clinical Intervention Research Official(s) and/or principal investigator(s): Christian Jespersen, DMSc, Study Chair, Affiliation: Department of Cardiology Y, Bispebjerg Hospital, Bispebjerg Bakke 23, DK 2400 Copenhagen NV, Denmark. Christian Gluud, DMSc, Principal Investigator, Affiliation: Copenhagen Trial Unit, Center of Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK-2100 Copenhagen
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.
Clinical Details
Official title: The Effect of Clarithromycin on Mortality and Morbidity in Patients With Ischemic Heart Disease - a Randomized, Placebo Controlled, Double Blinded, Multicentre, Clinical Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Composite consisting of: death regardless of causenon-fatal AMI or unstable angina pectoris whichever occurred first
Secondary outcome: Composite of: cardiovascular deathnon-fatal AMI or unstable angina pectoris whichever occurred first
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 84 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen 2100, Denmark
H:S Amager Hospital, Copenhagen 2300, Denmark
H:S Bispebjerg Hospital, Copenhagen 2400, Denmark
H:S Rigshospitalet, Copenhagen 2100, Denmark
H:S Frederiksberg Hospital, Frederiksberg 2000, Denmark
H:S Hvidovre Hospital, Hvidovre 2650, Denmark
Additional Information
Related publications: Hansen S, Als-Nielsen B, Damgaard M, Helø OH, Petersen L, Jespersen CM. Intervention with clarithromycin in patients with stable coronary heart disease. The CLARICOR Trial Design. Heart Drug 2001;1:14-9.
Starting date: October 1999
Last updated: May 4, 2006
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