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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01566201 |
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Date of registration:
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27/03/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effects of Interleukin-1 Inhibition on Vascular and Left Ventricular Function in Rheumatoid Arthritis Patients With Coronary Artery Disease
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Scientific title:
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The Effect of Inhibition of Interleukin-1 Activity on Vascular and Left Ventricular Function in Patients With Coronary Artery Disease and Coexistent Rheumatoid Arthritis |
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Date of first enrolment:
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March 2011 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01566201 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Greece
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Contacts
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Name:
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John P. Lekakis, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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2nd Cardiology Department, University of Athens, Greece |
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Name:
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Ignatios Ikonomidis, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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2nd Cardiology Department, University of Athens, Greece |
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Name:
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Ioanna Andreadou, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Pharmaceutical Chemistry, University of Athens Medical School, Greece |
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Name:
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Ioannis Paraskevaidis, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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2nd Cardiology Department, University of Athens, Greece |
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Name:
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Maria Anastasiou-Nana, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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2nd Cardiology Department, University of Athens, Greece |
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Name:
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Stavros Tzortzis, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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2nd Cardiology Department, University of Athens, Greece |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with rheumatoid arthritis and coexistent coronary artery disease or without
CAD who had an inadequate response to disease modifying antirheumatic drugs (DMARDs)
and corticosteroids and were going to initiate treatment with interleukin-1
inhibitor.
Exclusion Criteria:
- Familiar hyperlipidemia
- Diabetes mellitus
- Chronic obstructive pulmonary disease or asthma, moderate or severe valvular heart
disease, primary cardiomyopathies,malignant tumors
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Inflammation
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Coronary Artery Disease
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Rheumatoid Arthritis
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Intervention(s)
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Drug: anakinra
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Drug: placebo
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Primary Outcome(s)
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Improvement in vascular and left ventricular function after anakinra
[Time Frame: 3 hours after treatment]
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Secondary Outcome(s)
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Reduction of nitrooxidative stress and apoptosis after anakinra treatment
[Time Frame: 3 hours after treatment]
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Secondary ID(s)
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RCT-RACAD-ATTIKON-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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