Early Rheumatoid Arthritis COR Intervention

Cardiovascular Diseases Clinical Trial

— ERACORI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02246257
• Other study ID #: OdenseUH
• Status: Recruiting
• Phase: N/A
• Start date: September 2014
• Est. completion date: September 2024

Study information

• Verified date: May 2022
• Source: Odense University Hospital
• Contact: Annemarie L Svensson, MD, PhD
• Phone: +45 28 555 126
• Email: lyng.annemarie[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Cardiovascular Diseases
• Rheumatoid Arthritis

Intervention

Other:
• Simvastatin
LDL > 2.5 is treated with 40 mg
• Losartan
BT > 140/90 mmHg treated with 50 mg OD
• Losartan
DM BT > 130/80 mmHg treated with 50 mg OD
• Losartan
Microalbuminuria (urinary albumin creatinin ratio > 30 mg) treated with 100 mg OD
• Metformin
HBA1C > 48 mmol/mol treated with 500 mg increased dose to 2,000 mg in 4 weeks
• Outpatient rheumatology department
(4 times yearly)
• Refered to general practice

Locations

Country	Name	City	State
Denmark	Department of Rheumathology, Frederiksberg and Bispebjerg univeristy Hospital	Frederiksberg	Region Of Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
MD, PhD, Annemarie Lyng Svensson

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Major Cardiac Event (death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke and cardiac revascularization)	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.	Up to 5 years
Secondary	Time to Death Due to Any Cause	Days from randomization to death. If no death then censoring occurs at earliest of termination date or efficacy cutoff date of 31 Dec 2020. Kaplan-Meier estimate of the mean	Up to 5 years
Secondary	Time to Non-cardiovascular Death	Days from randomization to death from a non-cardiovascular cause. If no event, then censoring occurs at earliest of termination date or efficacy cutoff date of 31 Dec 2020. Events will be adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean	Up to 5 years
Secondary	Time to Serious Adverse Event (hospitalizations)	Time from randomization to the first venous thromboembolic event. Kaplan-Meier estimate of the mean	Up to 5 years
Secondary	The proportion of patients having a treatment success	LDL cholesterol < 2.5 mmol/l; HbA1c < 48 mmol/mol (HbA1c < 6.5%),; Blood pressure < 140/90 mmHg for non-diabetic patients and < 130/80 mm Hg for diabetic patients and normoalbuminuria (urinary albumin creatinine ratio < 30 mg/g) after 1-year of follow-up this in agreement with present national guidelines, which will be adjusted accordingly to any future changes in the respective national guidelines.; Low RA disease activity DAS28-CRP < 3.2 and DAS28-CRP < 2.6 at 12, 24 and 60 months. Furthermore, all to hospitalisations will be adjudicated by the event committee	1, 2 and 5 years