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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
---|---|---|
Heart Disease Cardiovascular Disease | Drug: clarithromycin | Phase 3 |
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 (Clinical Trial) |
Actual Enrollment : | 4372 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
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 |
Study Start Date : | October 1999 |
Actual Primary Completion Date : | April 2000 |
Actual Study Completion Date : | September 2002 |

Arm | Intervention/treatment |
---|---|
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 |
Placebo Comparator: Placebo
Placebo comparator
|
Drug: clarithromycin |
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 84 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00121550
Denmark | |
Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9 | |
Copenhagen, Denmark, 2100 | |
H:S Rigshospitalet | |
Copenhagen, Denmark, 2100 | |
H:S Amager Hospital | |
Copenhagen, Denmark, 2300 | |
H:S Bispebjerg Hospital | |
Copenhagen, Denmark, 2400 | |
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 |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Christian Gluud, MD, DMSc, Copenhagen Trial Unit, Center for Clinical Intervention Research |
ClinicalTrials.gov Identifier: | NCT00121550 |
Other Study ID Numbers: |
1997-08-DP-42-RKF-13 CLARICOR; REC: KF01-076/99 DDPA: 2001-41-1496, DMA: 2612-975 |
First Posted: | July 21, 2005 Key Record Dates |
Last Update Posted: | August 11, 2016 |
Last Verified: | August 2016 |
Coronary heart disease Clarithromycin Macrolides Cardiovascular mortality Chlamydia pneumoniae |
Cardiovascular Diseases Heart Diseases Myocardial Ischemia Coronary Artery Disease Vascular Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases |
Clarithromycin Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |