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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.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02246257
Date of registration: 17/09/2014
Prospective Registration: Yes
Primary sponsor: MD, PhD, Annemarie Lyng Svensson
Public title: Early Rheumatoid Arthritis COR Intervention ERACORI
Scientific title: Multifactorial Intervention to Prevent Cardiovascular Disease in Patients With Early Rheumatoid Arthritis
Date of first enrolment: September 2014
Target sample size: 300
Recruitment status: Unknown status
URL:  https://clinicaltrials.gov/show/NCT02246257
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Denmark
Contacts
Name:     Annemarie Lyng Svesson, MD, PhD
Address: 
Telephone: 004528555126
Email: lyng.annemarie@gmail.com
Affiliation: 
Name:     Annemarie L Svensson, MD, PhD
Address: 
Telephone: +45 28 555 126
Email: lyng.annemarie@gmail.com
Affiliation: 
Name:     Torkell J Ellingsen, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Odense University Hospital
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Cardiovascular Diseases
Rheumatoid Arthritis
Intervention(s)
Other: Losartan
Other: Metformin
Other: Outpatient rheumatology department
Other: Refered to general practice
Other: Simvastatin
Primary Outcome(s)
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]
Secondary Outcome(s)
The proportion of patients having a treatment success [Time Frame: 1, 2 and 5 years]
Time to Death Due to Any Cause [Time Frame: Up to 5 years]
Time to Non-cardiovascular Death [Time Frame: Up to 5 years]
Time to Serious Adverse Event (hospitalizations) [Time Frame: Up to 5 years]
Secondary ID(s)
OdenseUH
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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