Multifactorial Intervention to Prevent Cardiovascular Disease in Patients With Early Rheumatoid Arthritis
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- MD, PhD, Annemarie Lyng Svensson
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Time to Major Cardiac Event (death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke and cardiac revascularization)
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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 patients with early RA. The primary endpoint, a composite of death from cardiovascular causes, non-fatal MI, non-fatal stroke and re-vascularisation, will be assessed after 5years' follow-up.
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 group are scheduled to occur at baseline and then after 2, 4 and 12 weeks and thereafter every third month for 5 years after randomisation. The control group will be monitored for RA disease activity and comorbidity after 2, 4 weeks, 12 weeks and thereafter following national guidelines for RA. Prevention of CVD risk factors in the control group will be treated in general practice according to national guidelines for diabetes (2011), hypertension (2009) and CVD (2013).
Investigators
MD, PhD, Annemarie Lyng Svensson
MD, PhD
Odense University Hospital
Eligibility 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).
Outcomes
Primary Outcomes
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
Days from randomization to the first of cardiac event. If no event, censoring occurs at earliest of termination date or efficacy cut-off date of 31 December 2020. Events will be adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean.
Secondary Outcomes
- Time to Serious Adverse Event (hospitalizations)(Up to 5 years)
- Time to Death Due to Any Cause(Up to 5 years)
- The proportion of patients having a treatment success(1, 2 and 5 years)
- Time to Non-cardiovascular Death(Up to 5 years)