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

• Status: Completed
• Trial end date: 2002-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Copenhagen Trial Unit, Center for Clinical Intervention Research
• Collaborators: Abbott; Copenhagen Hospital Corporation; Danish Heart Foundation; The 1991 Pharmacy Foundation; The Danish Medical Research Council
• Treatments: Clarithromycin

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