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
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Study First Received: July 13, 2005
Last Updated: May 4, 2006
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:
Cardiovascular Diseases
Heart Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014