Multifactorial Intervention to Prevent Cardiovascular Disease in Patients With Early Rheumatoid Arthritis (ERACORI)

NCT02246257 NA UNKNOWN

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.

Details

Lead sponsor	MD, PhD, Annemarie Lyng Svensson
Phase	NA
Status	UNKNOWN
Enrolment	300
Start date	2014-09
Completion	2024-09

Conditions

• Rheumatoid Arthritis
• Cardiovascular Diseases

Interventions

• Simvastatin
• Losartan
• Losartan
• Losartan
• Metformin
• Outpatient rheumatology department
• Refered to general practice

Primary outcomes

• Time to Major Cardiac Event (death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke and cardiac revascularization) — 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.

Countries

Denmark