multifactorial intervention to prevent cardiovascular disease in patients with early rheumatoid arthritis protocol for a multicentre randomised controlled trial

Open Access Protocol Multifactorial intervention to prevent cardiovascular disease in patients with early rheumatoid arthritis: protocol for a multicentre randomised controlled trial Annemarie Lyng Svensson,1 Robin Christensen,2 Frederik Persson,3 Brian Bridal Løgstrup,4 Annamaria Giraldi,5 Christian Graugaard,6 Ulrich Fredberg,7 Jesper Blegvad,7 Tina Thygesen,7 Inger Marie Jensen Hansen,8 Ada Colic,9 Döne Bagdat,9 Palle Ahlquist,10 Hanne Slott Jensen,1 Kim Hørslev-Petersen,11 Ekta Sheetal,12 Torben Grube Christensen,13 Lone Svendsen,14 Henrik Emmertsen,15 Torkell Ellingsen12,16 To cite: Svensson AL, Christensen R, Persson F, et al Multifactorial intervention to prevent cardiovascular disease in patients with early rheumatoid arthritis: protocol for a multicentre randomised controlled trial BMJ Open 2016;6:e009134 doi:10.1136/bmjopen-2015009134 ▸ Prepublication history for this paper is available online To view these files please visit the journal online (http://dx.doi.org/10.1136/ bmjopen-2015-009134) Received 22 June 2015 Revised 19 September 2015 Accepted 14 October 2015 For numbered affiliations see end of article Correspondence to Professor Torkell Ellingsen; torkell.ellingsen@rsyd.dk ABSTRACT Introduction: Cardiovascular morbidity is a major burden in patients with rheumatoid arthritis (RA) In this study, we compare the effect of a targeted, intensified, multifactorial intervention with that of conventional treatment of modifiable risk factors for cardiovascular disease (CVD) in patients with early RA fulfilling the 2010 American College of Rheumatology European League Against Rheumatism (ACR/EULAR) criteria Methods and analysis: The study is a prospective, randomised, open label trial with blinded end point assessment and balanced randomisation (1:1) conducted in 10 outpatient clinics in Denmark The primary end point after years of follow-up is a composite of death from cardiovascular causes, nonfatal myocardial infarction, non-fatal stroke and cardiac revascularisation Secondary outcomes are: the proportion of patients achieving low-density lipoprotein cholesterol