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Trial record 63 of 399 for:    CLARITHROMYCIN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 13, 2005
First Posted Date  ICMJE July 21, 2005
Last Update Posted Date August 11, 2016
Study Start Date  ICMJE October 1999
Actual Primary Completion Date April 2000   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2005)
  • Composite consisting of: death regardless of cause
  • non-fatal AMI or
  • unstable angina pectoris whichever occurred first
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00121550 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2005)
  • Composite of: cardiovascular death
  • non-fatal AMI or
  • unstable angina pectoris whichever occurred first
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The CLARICOR Trial: Effect of Clarithromycin on Mortality and Morbidity in Patients With Ischemic Heart Disease
Official Title  ICMJE The Effect of Clarithromycin on Mortality and Morbidity in Patients With Ischemic Heart Disease - a Randomized, Placebo Controlled, Double Blinded, Multicentre, Clinical Trial
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Disease
  • Cardiovascular Disease
Intervention  ICMJE Drug: clarithromycin
Study Arms  ICMJE
  • 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.
    Intervention: Drug: clarithromycin
  • Placebo Comparator: Placebo
    Placebo comparator
    Intervention: Drug: clarithromycin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2005)
4372
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2002
Actual Primary Completion Date April 2000   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00121550
Other Study ID Numbers  ICMJE 1997-08-DP-42-RKF-13 CLARICOR;
REC: KF01-076/99
DDPA: 2001-41-1496,
DMA: 2612-975
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christian Gluud, Copenhagen Trial Unit, Center for Clinical Intervention Research
Study Sponsor  ICMJE Copenhagen Trial Unit, Center for Clinical Intervention Research
Collaborators  ICMJE
  • Danish Heart Foundation
  • Copenhagen Hospital Corporation
  • The Danish Medical Research Council
  • The 1991 Pharmacy Foundation
  • Abbott
Investigators  ICMJE
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
PRS Account Copenhagen Trial Unit, Center for Clinical Intervention Research
Verification Date August 2016

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