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

This study has been completed.
Sponsor:
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
First received: July 13, 2005
Last updated: May 4, 2006
Last verified: September 1999

July 13, 2005
May 4, 2006
October 1999
Not Provided
  • Composite consisting of: death regardless of cause
  • non-fatal AMI or
  • unstable angina pectoris whichever occurred first
Same as current
Complete list of historical versions of study NCT00121550 on ClinicalTrials.gov Archive Site
  • Composite of: cardiovascular death
  • non-fatal AMI or
  • unstable angina pectoris whichever occurred first
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Heart Disease
  • Cardiovascular Disease
Drug: clarithromycin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4372
September 2002
Not Provided

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
Both
18 Years to 84 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00121550
1997-08-DP-42-RKF-13 CLARICOR;, REC: KF01-076/99, DDPA: 2001-41-1496,, DMA: 2612-975
Not Provided
Not Provided
Copenhagen Trial Unit, Center for Clinical Intervention Research
  • Danish Heart Foundation
  • Copenhagen Hospital Corporation
  • The Danish Medical Research Council
  • The 1991 Pharmacy Foundation
  • Abbott
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
Copenhagen Trial Unit, Center for Clinical Intervention Research
September 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP