Heart DiseasePhase 3NCT00121550
The CLARICOR Trial: Effect of Clarithromycin on Mortality and Morbidity in Patients With Ischemic Heart Disease
A Phase 3 study testing clarithromycin in people with Heart Disease and Cardiovascular Disease, run by Copenhagen Trial Unit, Center for Clinical Intervention Research at 6 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Heart Disease, Cardiovascular Disease
- What is being tested?
- clarithromycin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,372 participants
- Where
- 6 sitesDenmark
- Study dates
- Oct 1999to Sep 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged 18 to 85 years and
- previous acute myocardial infarction (AMI) or
- previous or present angina pectoris and
- signed informed concent
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Denmark6 sites
Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9
Copenhagen, 2100
H:S Rigshospitalet
Copenhagen, 2100
H:S Amager Hospital
Copenhagen, 2300
H:S Bispebjerg Hospital
Copenhagen, 2400
H:S Frederiksberg Hospital
Frederiksberg, 2000
H:S Hvidovre Hospital
Hvidovre, 2650
About this study
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
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.
Read the detailed 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.
- Conditions
- Heart Disease, Cardiovascular Disease
- Being tested
- clarithromycin
- Keywords
- Coronary heart disease, Clarithromycin, Macrolides, Cardiovascular mortality, Chlamydia pneumoniae
- Medical subject headings
- Heart Diseases, Cardiovascular Diseases, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clarithromycinDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: clarithromycin |
| Placebo | Placebo comparator | Placebo comparator Receives: Drug: clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startOct 1999
- Primary completionApr 2000
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen Trial Unit, Center for Clinical Intervention Research
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Heart Foundation, Copenhagen Hospital Corporation, The Danish Medical Research Council, The 1991 Pharmacy Foundation, Abbott
- Responsible party
- Principal investigator, Christian Gluud, Copenhagen Trial Unit, Center for Clinical Intervention Research
- Investigators
- Christian Jespersen, DMSc, Study chair, Department of Cardiology Y, Bispebjerg Hospital, Bispebjerg Bakke 23, DK 2400 Copenhagen NV, Denmark.Christian Gluud, DMSc, Principal investigator, Copenhagen Trial Unit, Center of Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK-2100 Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00121550
- Sponsor's protocol ID
- 1997-08-DP-42-RKF-13 CLARICOR;
- Other IDs
- REC: KF01-076/99, DDPA: 2001-41-1496,, DMA: 2612-975
- Status last verified
- Aug 2016
- First submitted
- 13 Jul 2005
- Last updated
- 11 Aug 2016
- Results posted
- No
Publications
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, 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.
PubMed 16339220Jensen GB, Olsen MH, Jensen MT, Lindschou J, Winkel P, Hilden J, Jakobsen JC, Engstrom J, Kolmos HJ, Kastrup J, Sajadieh A, Gluud C; CLARICOR Group. Effect of clarithromycin versus placebo on risk of atrial fibrillation. Dan Med J. 2026 Feb 5;73(3):A08250630. doi: 10.61409/A08250630.
PubMed 41772998Winkel 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.
PubMed 34384145Winkel 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.
PubMed 32819979Bjerre 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.
PubMed 32289619Schroder 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.
PubMed 32114892Winkel 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.
PubMed 31093541Winkel 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.
PubMed 30228904Carlsson 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.
PubMed 29686027Kjoller 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.
PubMed 25066559Lyngbaek 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.
PubMed 23723326Winkel 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.
PubMed 21447948Harutyunyan 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.
PubMed 21108561Jensen 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.
PubMed 19920766
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00121550
- Acronym / sponsor ID
- 1997-08-DP-42-RKF-13 CLARICOR;
- Conditions
- Heart Disease, Cardiovascular Disease
- Keywords
- Coronary heart disease, Clarithromycin, Macrolides, Cardiovascular mortality, Chlamydia pneumoniae
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,372 participants (actual)
- Lead sponsor
- Copenhagen Trial Unit, Center for Clinical Intervention ResearchUniversity, hospital or other
- Collaborators
- Danish Heart Foundation, Copenhagen Hospital Corporation, The Danish Medical Research Council, The 1991 Pharmacy Foundation, Abbott
- Study start
- Oct 1999
- Primary completion
- Apr 2000 (actual)
- Study completion
- Sep 2002 (actual)
- First posted
- 21 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clarithromycin | Experimental | Drug: clarithromycinClarithromycin 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. |
| Placebo | Placebo comparator | Drug: clarithromycinPlacebo comparator |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients aged 18 to 85 years and
- previous acute myocardial infarction (AMI) or
- previous or present angina pectoris and
- signed informed concent
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clarithromycin | Drug | Clarithromycin, Placebo |
Primary outcome
Composite consisting of: death regardless of cause
non-fatal AMI or
unstable angina pectoris whichever occurred first
3 secondary outcomes
Composite of: cardiovascular death
non-fatal AMI or
unstable angina pectoris whichever occurred first
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
- BackgroundHansen 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.
- Results publication: PubMed 16339220Jespersen 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.
- Derived from this study: PubMed 41772998Jensen GB, Olsen MH, Jensen MT, Lindschou J, Winkel P, Hilden J, Jakobsen JC, Engstrom J, Kolmos HJ, Kastrup J, Sajadieh A, Gluud C; CLARICOR Group. Effect of clarithromycin versus placebo on risk of atrial fibrillation. Dan Med J. 2026 Feb 5;73(3):A08250630. doi: 10.61409/A08250630.
- Derived from this study: PubMed 34384145Winkel 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.
- Derived from this study: PubMed 32819979Winkel 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.
- Derived from this study: PubMed 32289619Bjerre 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.
- Derived from this study: PubMed 32114892Schroder 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.
- Derived from this study: PubMed 31093541Winkel 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.
- Derived from this study: PubMed 30228904Winkel 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.
- Derived from this study: PubMed 29686027Carlsson 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.
- Derived from this study: PubMed 25066559Kjoller 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.
- Derived from this study: PubMed 23723326Lyngbaek 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.
Related trials for Heart Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Jespersen, DMSc study chair
Department of Cardiology Y, Bispebjerg Hospital, Bispebjerg Bakke 23, DK 2400 Copenhagen NV, Denmark.
Christian Gluud, DMSc principal investigator
Copenhagen Trial Unit, Center of Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK-2100 Copenhagen
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing clarithromycin in people with Heart Disease and Cardiovascular Disease, run by Copenhagen Trial Unit, Center for Clinical Intervention Research at 6 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite consisting of: death regardless of cause. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00121550, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2016.