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

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ClinicalTrials.gov Identifier: NCT00121550
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : August 11, 2016
Sponsor:
Collaborators:
Danish Heart Foundation
Copenhagen Hospital Corporation
The Danish Medical Research Council
The 1991 Pharmacy Foundation
Abbott
Information provided by (Responsible Party):
Christian Gluud, Copenhagen Trial Unit, Center for Clinical Intervention Research

Study Description
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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.


Condition or disease Intervention/treatment Phase
Heart Disease Cardiovascular Disease Drug: clarithromycin Phase 3

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4372 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 1999
Actual Primary Completion Date : April 2000
Actual Study Completion Date : September 2002

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Clarithromycin
Clarithromycin is a lipophilic semi-synthetic macrolide antibiotic. The lipophilic nature of the drug allows it to easily penetrate into body fluids and tissues and accumulate intracellularly. Side effects are few, apart from trivial gastrointestinal complaints, and severe side effects are rarely observed during standard treatment.
 Drug: clarithromycin
Placebo Comparator: Placebo
Placebo comparator
 Drug: clarithromycin


Outcome Measures
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Primary Outcome Measures :
  1. Composite consisting of: death regardless of cause
  2. non-fatal AMI or
  3. unstable angina pectoris whichever occurred first

Secondary Outcome Measures :
  1. Composite of: cardiovascular death
  2. non-fatal AMI or
  3. unstable angina pectoris whichever occurred first

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00121550


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

Other 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Christian Gluud, MD, DMSc, Copenhagen Trial Unit, Center for Clinical Intervention Research
ClinicalTrials.gov Identifier: NCT00121550     History of Changes
Other Study ID Numbers: 1997-08-DP-42-RKF-13 CLARICOR;
REC: KF01-076/99
DDPA: 2001-41-1496,
DMA: 2612-975
First Posted: July 21, 2005    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016
Keywords provided by Christian Gluud, Copenhagen Trial Unit, Center for Clinical Intervention Research:
Coronary heart disease
Clarithromycin
Macrolides
Cardiovascular mortality
Chlamydia pneumoniae
Additional relevant MeSH terms:
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Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
 Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors