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

August 10, 2016 updated by: Christian Gluud, Copenhagen Trial Unit, Center for Clinical Intervention Research

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

4372

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 82 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo comparator
Drug: clarithromycin
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen Trial Unit, Center for Clinical Intervention Research

Collaborators

Abbott
The Danish Medical Research Council
Danish Heart Foundation
Copenhagen Hospital Corporation
The 1991 Pharmacy Foundation

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1999

Primary Completion (Actual)

April 1, 2000

Study Completion (Actual)

September 1, 2002

Study Registration Dates

First Submitted

July 13, 2005

First Submitted That Met QC Criteria

July 19, 2005

First Posted (Estimate)

July 21, 2005

Study Record Updates

Last Update Posted (Estimate)

August 11, 2016

Last Update Submitted That Met QC Criteria

August 10, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1997-08-DP-42-RKF-13 CLARICOR;
  • REC: KF01-076/99
  • DDPA: 2001-41-1496,
  • DMA: 2612-975

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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