NCT00121550

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,372

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 1999

Typical duration for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2000

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2002

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
Last Updated

August 11, 2016

Status Verified

August 1, 2016

Enrollment Period

6 months

First QC Date

July 13, 2005

Last Update Submit

August 10, 2016

Conditions

Heart DiseaseCardiovascular Disease

Keywords

Coronary heart diseaseClarithromycinMacrolidesCardiovascular mortalityChlamydia pneumoniae

Outcome Measures

Primary Outcomes (3)

  • Composite consisting of: death regardless of cause

  • non-fatal AMI or

  • unstable angina pectoris whichever occurred first

Secondary Outcomes (3)

  • Composite of: cardiovascular death

  • non-fatal AMI or

  • unstable angina pectoris whichever occurred first

Study Arms (2)

Clarithromycin

EXPERIMENTAL

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

PLACEBO COMPARATOR

Placebo comparator

Drug: clarithromycin

Interventions

clarithromycinDRUG
ClarithromycinPlacebo

Eligibility Criteria

Age18 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients aged 18 to 85 years and
  • previous acute myocardial infarction (AMI) or
  • previous or present angina pectoris and
  • signed informed concent

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9

Copenhagen, 2100, Denmark

Location

H:S Rigshospitalet

Copenhagen, 2100, Denmark

Location

H:S Amager Hospital

Copenhagen, 2300, Denmark

Location

H:S Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

H:S Frederiksberg Hospital

Frederiksberg, 2000, Denmark

Location

H:S Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (15)

  • 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.

    BACKGROUND

  • Jespersen CM, Als-Nielsen B, Damgaard M, Hansen JF, Hansen S, Helo OH, Hildebrandt P, Hilden J, Jensen GB, Kastrup J, Kolmos HJ, Kjoller E, Lind I, Nielsen H, Petersen L, Gluud C; CLARICOR Trial Group. Randomised placebo controlled multicentre trial to assess short term clarithromycin for patients with stable coronary heart disease: CLARICOR trial. BMJ. 2006 Jan 7;332(7532):22-7. doi: 10.1136/bmj.38666.653600.55. Epub 2005 Dec 8.

    PMID: 16339220RESULT

  • Winkel P, Hilden J, Jakobsen JC, Lindschou J, Jensen GB, Kjoller E, Sajadieh A, Kastrup J, Kolmos HJ, Larsson A, Arnlov J, Bjerre M, Gluud C. A screening method to spot biomarkers that may warn of serious events in a chronic disease - illustrated by cardiological CLARICOR trial data. Clin Chem Lab Med. 2021 Aug 12;59(11):1852-1860. doi: 10.1515/cclm-2021-0333. Print 2021 Oct 26.

    PMID: 34384145DERIVED

  • Winkel P, Jakobsen JC, Hilden J, Jensen GB, Kjoller E, Sajadieh A, Kastrup J, Kolmos HJ, Iversen KK, Bjerre M, Larsson A, Arnlov J, Gluud C. Prognostic value of 12 novel cardiological biomarkers in stable coronary artery disease. A 10-year follow-up of the placebo group of the Copenhagen CLARICOR trial. BMJ Open. 2020 Aug 20;10(8):e033720. doi: 10.1136/bmjopen-2019-033720.

    PMID: 32819979DERIVED

  • Bjerre M, Hilden J, Winkel P, Jensen GB, Kjoller E, Sajadieh A, Kastrup J, Kolmos HJ, Larsson A, Arnlov J, Jakobsen JC, Gluud C. Serum osteoprotegerin as a long-term predictor for patients with stable coronary artery disease and its association with diabetes and statin treatment: A CLARICOR trial 10-year follow-up substudy. Atherosclerosis. 2020 May;301:8-14. doi: 10.1016/j.atherosclerosis.2020.03.030. Epub 2020 Apr 4.

    PMID: 32289619DERIVED

  • Schroder J, Jakobsen JC, Winkel P, Hilden J, Jensen GB, Sajadieh A, Larsson A, Arnlov J, Harutyunyan M, Johansen JS, Kjoller E, Gluud C, Kastrup J. Prognosis and Reclassification by YKL-40 in Stable Coronary Artery Disease. J Am Heart Assoc. 2020 Mar 3;9(5):e014634. doi: 10.1161/JAHA.119.014634. Epub 2020 Mar 2.

    PMID: 32114892DERIVED

  • Winkel P, Jakobsen JC, Hilden J, Lange T, Jensen GB, Kjoller E, Sajadieh A, Kastrup J, Kolmos HJ, Larsson A, Arnlov J, Gluud C. Predictors for major cardiovascular outcomes in stable ischaemic heart disease (PREMAC): statistical analysis plan for data originating from the CLARICOR (clarithromycin for patients with stable coronary heart disease) trial. Diagn Progn Res. 2017 Mar 29;1:10. doi: 10.1186/s41512-017-0009-y. eCollection 2017.

    PMID: 31093541DERIVED

  • Winkel P, Jakobsen JC, Hilden J, Jensen G, Kjoller E, Sajadieh A, Kastrup J, Kolmos HJ, Larsson A, Arnlov J, Gluud C. Prognostic value of routinely available data in patients with stable coronary heart disease. A 10-year follow-up of patients sampled at random times during their disease course. Open Heart. 2018 Sep 5;5(2):e000808. doi: 10.1136/openhrt-2018-000808. eCollection 2018.

    PMID: 30228904DERIVED

  • Carlsson AC, Ruge T, Kjoller E, Hilden J, Kolmos HJ, Sajadieh A, Kastrup J, Jensen GB, Larsson A, Nowak C, Jakobsen JC, Winkel P, Gluud C, Arnlov J. 10-Year Associations Between Tumor Necrosis Factor Receptors 1 and 2 and Cardiovascular Events in Patients With Stable Coronary Heart Disease: A CLARICOR (Effect of Clarithromycin on Mortality and Morbidity in Patients With Ischemic Heart Disease) Trial Substudy. J Am Heart Assoc. 2018 Apr 23;7(9):e008299. doi: 10.1161/JAHA.117.008299.

    PMID: 29686027DERIVED

  • Kjoller E, Hilden J, Winkel P, Galatius S, Frandsen NJ, Jensen GB, Fischer Hansen J, Kastrup J, Jespersen CM, Hildebrandt P, Kolmos HJ, Gluud C; CLARICOR Trial Group. Agreement between public register and adjudication committee outcome in a cardiovascular randomized clinical trial. Am Heart J. 2014 Aug;168(2):197-204.e1-4. doi: 10.1016/j.ahj.2013.12.032. Epub 2014 May 4.

    PMID: 25066559DERIVED

  • Lyngbaek S, Winkel P, Gotze JP, Kastrup J, Gluud C, Kolmos HJ, Kjoller E, Jensen GB, Hansen JF, Hildebrandt P, Hilden J; CLARICOR Trial Group. Risk stratification in stable coronary artery disease is possible at cardiac troponin levels below conventional detection and is improved by use of N-terminal pro-B-type natriuretic peptide. Eur J Prev Cardiol. 2014 Oct;21(10):1275-84. doi: 10.1177/2047487313492099. Epub 2013 May 30.

    PMID: 23723326DERIVED

  • Winkel P, Hilden J, Fischer Hansen J, Hildebrandt P, Kastrup J, Kolmos HJ, Kjoller E, Jespersen CM, Gluud C, Jensen GB; CLARICOR Trial Group. Excess sudden cardiac deaths after short-term clarithromycin administration in the CLARICOR trial: why is this so, and why are statins protective? Cardiology. 2011;118(1):63-7. doi: 10.1159/000324533. Epub 2011 Mar 26.

    PMID: 21447948DERIVED

  • Harutyunyan MJ, Mathiasen AB, Winkel P, Gotze JP, Hansen JF, Hildebrandt P, Jensen GB, Hilden J, Jespersen CM, Kjoller E, Kolmos HJ, Gluud C, Kastrup J; CLARICOR Trial Group. High-sensitivity C-reactive protein and N-terminal pro-B-type natriuretic peptide in patients with stable coronary artery disease: a prognostic study within the CLARICOR trial. Scand J Clin Lab Invest. 2011 Feb;71(1):52-62. doi: 10.3109/00365513.2010.538081. Epub 2010 Nov 25.

    PMID: 21108561DERIVED

  • Jensen GB, Hilden J, Als-Nielsen B, Damgaard M, Hansen JF, Hansen S, Helo OH, Hildebrandt P, Kastrup J, Kolmos HJ, Kjoller E, Lind I, Nielsen H, Petersen L, Jespersen CM, Gluud C; CLARICOR Trial Group. Statin treatment prevents increased cardiovascular and all-cause mortality associated with clarithromycin in patients with stable coronary heart disease. J Cardiovasc Pharmacol. 2010 Feb;55(2):123-8. doi: 10.1097/FJC.0b013e3181c87e37.

    PMID: 19920766DERIVED

  • Jespersen CM, Kolmos HJ, Frydendall N, Hilden J, Gluud C, Hansen JF; CLARICOR Trial Group. Compliance with and short-term adverse events from clarithromycin versus placebo in patients with stable coronary heart disease: the CLARICOR trial. J Antimicrob Chemother. 2009 Aug;64(2):411-5. doi: 10.1093/jac/dkp190. Epub 2009 May 28.

    PMID: 19477891DERIVED

MeSH Terms

Conditions

Heart DiseasesCardiovascular DiseasesCoronary Disease

Interventions

Clarithromycin

Condition Hierarchy (Ancestors)

Myocardial IschemiaVascular Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Christian Jespersen, DMSc

    Department of Cardiology Y, Bispebjerg Hospital, Bispebjerg Bakke 23, DK 2400 Copenhagen NV, Denmark.

    STUDY CHAIR

  • Christian Gluud, DMSc

    Copenhagen Trial Unit, Center of Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK-2100 Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, DMSc

Study Record Dates

First Submitted

July 13, 2005

First Posted

July 21, 2005

Study Start

October 1, 1999

Primary Completion

April 1, 2000

Study Completion

September 1, 2002

Last Updated

August 11, 2016

Record last verified: 2016-08

Locations

DK(6)