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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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30 May 2022 |
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Main ID: |
NCT02246257 |
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Date of registration:
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17/09/2014 |
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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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Early Rheumatoid Arthritis COR Intervention
ERACORI |
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Scientific title:
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Multifactorial Intervention to Prevent Cardiovascular Disease in Patients With Early Rheumatoid Arthritis |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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300 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02246257 |
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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: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Annemarie Lyng Svesson, MD, PhD |
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Address:
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Telephone:
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004528555126 |
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Email:
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lyng.annemarie@gmail.com |
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Affiliation:
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Name:
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Annemarie L Svensson, MD, PhD |
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Address:
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Telephone:
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+45 28 555 126 |
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Email:
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lyng.annemarie@gmail.com |
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Affiliation:
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Name:
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Torkell J Ellingsen, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Odense University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- RA according to the revised American College of Rheumatology (ACR) 2010 criteria and
plasma LDL > 2.5mmol/l.
Exclusion Criteria:
- Pregnancy
- Lactation
- Ongoing/previous DMARD therapy
- Ongoing/previous steorid therapy
- Contraindication to any of the trial drugs
- Current infection with parvovirus B19, hepatitis B, hepatitis C or human immune
deficiency virus. Previous report of hospitalisation for myocardial ischaemia defined
as follows: a) non-fatal myocardial infarction (MI) defined according to national and
international guidelines. b) Acute coronary syndrome (ACS) including acute ischaemic
symptoms with possible biomarker changes or elctrocardiographic changes that to not
meet the criteria for MI, c) angina pectoris, d) revascularisation (percutaneous
coronary intervention (PCI) or coronary artery bypass grafting (CABG).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Cardiovascular Diseases
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Intervention(s)
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Other: Metformin
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Other: Losartan
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Other: Refered to general practice
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Other: Simvastatin
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Other: Outpatient rheumatology department
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Primary Outcome(s)
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Time to Major Cardiac Event (death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke and cardiac revascularization)
[Time Frame: Up to 5 years]
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Secondary Outcome(s)
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Time to Death Due to Any Cause
[Time Frame: Up to 5 years]
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Time to Serious Adverse Event (hospitalizations)
[Time Frame: Up to 5 years]
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The proportion of patients having a treatment success
[Time Frame: 1, 2 and 5 years]
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Time to Non-cardiovascular Death
[Time Frame: Up to 5 years]
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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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