Status:
UNKNOWN
Early Rheumatoid Arthritis COR Intervention
Lead Sponsor:
MD, PhD, Annemarie Lyng Svensson
Conditions:
Rheumatoid Arthritis
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary aim of our present study is to evaluate the effect of a targeted, intensified, multidimensional intervention compared to conventional treatment of modifiable risk factors for CVD in patien...
Detailed Description
The study is a prospective randomised open, blinded endpoint trial with balanced randomisation (1:1) conducted in seven outpatient clinics in Denmark. Follow-up visits for patients in the intervention...
Eligibility Criteria
Inclusion
- RA according to the revised American College of Rheumatology (ACR) 2010 criteria and plasma LDL \> 2.5mmol/l.
Exclusion
- 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).
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT02246257
Start Date
September 1 2014
End Date
September 1 2024
Last Update
May 23 2022
Active Locations (1)
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1
Department of Rheumathology, Frederiksberg and Bispebjerg univeristy Hospital
Frederiksberg, Region of Copenhagen, Denmark, 2000