The CLARICOR Trial: Effect of Clarithromycin on Mortality and Morbidity in Patients With Ischemic Heart Disease
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Composite consisting of: death regardless of cause
- non-fatal AMI or
- unstable angina pectoris whichever occurred first
- 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 |
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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00121550
| Denmark | |
| Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9 | |
| Copenhagen, Denmark, 2100 | |
| H:S Amager Hospital | |
| Copenhagen, Denmark, 2300 | |
| H:S Bispebjerg Hospital | |
| Copenhagen, Denmark, 2400 | |
| H:S Rigshospitalet | |
| Copenhagen, Denmark, 2100 | |
| H:S Frederiksberg Hospital | |
| Frederiksberg, Denmark, 2000 | |
| H:S Hvidovre Hospital | |
| Hvidovre, Denmark, 2650 | |
| 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:
|
Coronary Artery Disease Heart Diseases Myocardial Ischemia Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Vascular Diseases |
Clarithromycin Anti-Bacterial Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protein Synthesis Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015