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

This study has been completed.

First Received: July 13, 2005 Last Updated: May 4, 2006 History of Changes

Sponsor:	Copenhagen Trial Unit, Center for Clinical Intervention Research
Collaborators:	Danish Heart Foundation Copenhagen Hospital Corporation The Danish Medical Research Council The 1991 Pharmacy Foundation Abbott
Information provided by:	Copenhagen Trial Unit, Center for Clinical Intervention Research
ClinicalTrials.gov Identifier:	NCT00121550

Purpose

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.

Condition	Intervention	Phase
Heart Disease Cardiovascular Disease	Drug: clarithromycin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Angina Coronary Artery Disease Heart Diseases Pneumonia

Drug Information available for: Clarithromycin

U.S. FDA Resources

Further study details as provided by Copenhagen Trial Unit, Center for Clinical Intervention Research:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	4372
Study Start Date:	October 1999
Estimated Study Completion Date:	September 2002

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

Ages Eligible for Study:	18 Years to 84 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121550

Locations

Denmark
Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9
Copenhagen, Denmark, 2100
H:S Bispebjerg Hospital
Copenhagen, Denmark, 2400
H:S Rigshospitalet
Copenhagen, Denmark, 2100
H:S Amager Hospital
Copenhagen, Denmark, 2300
H:S Hvidovre Hospital
Hvidovre, Denmark, 2650
H:S Frederiksberg Hospital
Frederiksberg, Denmark, 2000

Sponsors and Collaborators

Copenhagen Trial Unit, Center for Clinical Intervention Research

Danish Heart Foundation

Copenhagen Hospital Corporation

The Danish Medical Research Council

The 1991 Pharmacy Foundation

Abbott

Investigators

Study Chair:	Christian Jespersen, DMSc	Department of Cardiology Y, Bispebjerg Hospital, Bispebjerg Bakke 23, DK 2400 Copenhagen NV, Denmark.
Principal Investigator:	Christian Gluud, DMSc	Copenhagen Trial Unit, Center of Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK-2100 Copenhagen

More Information

Publications:

Jespersen CM, Als-Nielsen B, Damgaard M, Hansen JF, Hansen S, Helo OH, Hildebrandt P, Hilden J, Jensen GB, Kastrup J, Kolmos HJ, Kjoller E, Lind I, Nielsen H, Petersen L, Gluud C; CLARICOR Trial Group. Randomised placebo controlled multicentre trial to assess short term clarithromycin for patients with stable coronary heart disease: CLARICOR trial. BMJ. 2006 Jan 7;332(7532):22-7. Epub 2005 Dec 8. Erratum in: BMJ. 2006 Jan 21;332(7534):151.

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.

Study ID Numbers:	1997-08-DP-42-RKF-13 CLARICOR;, REC: KF01-076/99, DDPA: 2001-41-1496,, DMA: 2612-975
Study First Received:	July 13, 2005
Last Updated:	May 4, 2006
ClinicalTrials.gov Identifier:	NCT00121550 History of Changes
Health Authority:	Denmark: Danish Medicines Agency; Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Copenhagen Trial Unit, Center for Clinical Intervention Research:

Coronary heart disease
Clarithromycin
Macrolides
Cardiovascular mortality
Chlamydia pneumoniae

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Clarithromycin
Heart Diseases
Molecular Mechanisms of Pharmacological Action

Therapeutic Uses
Myocardial Ischemia
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010