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

Cardiovascular Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00121550
• Other study ID #: 1997-08-DP-42-RKF-13 CLARICOR
• Secondary ID: REC: KF01-076/99
• Status: Completed
• Phase: Phase 3
• First received: July 13, 2005
• Last updated: August 10, 2016
• Start date: October 1999
• Est. completion date: September 2002

Study information

• Verified date: August 2016
• Source: Copenhagen Trial Unit, Center for Clinical Intervention Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4372
• Est. completion date: September 2002
• Est. primary completion date: April 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 84 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Coronary Artery Disease
• Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• clarithromycin

Locations

Country	Name	City	State
Denmark	Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9	Copenhagen
Denmark	H:S Amager Hospital	Copenhagen
Denmark	H:S Bispebjerg Hospital	Copenhagen
Denmark	H:S Rigshospitalet	Copenhagen
Denmark	H:S Frederiksberg Hospital	Frederiksberg
Denmark	H:S Hvidovre Hospital	Hvidovre

Sponsors (6)

Lead Sponsor	Collaborator
Copenhagen Trial Unit, Center for Clinical Intervention Research	Abbott, Copenhagen Hospital Corporation, Danish Heart Foundation, The 1991 Pharmacy Foundation, The Danish Medical Research Council

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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.

Jespersen CM, Als-Nielsen B, Damgaard M, Hansen JF, Hansen S, Helø OH, Hildebrandt P, Hilden J, Jensen GB, Kastrup J, Kolmos HJ, Kjøller E, Lind I, Nielsen H, Petersen L, Gluud C; CLARICOR Trial Group. Randomised placebo controlled multicentre trial to as — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite consisting of: death regardless of cause
Primary	non-fatal AMI or
Primary	unstable angina pectoris whichever occurred first
Secondary	Composite of: cardiovascular death
Secondary	non-fatal AMI or
Secondary	unstable angina pectoris whichever occurred first