Early Rheumatoid Arthritis COR Intervention
ERACORI
Multifactorial Intervention to Prevent Cardiovascular Disease in Patients With Early Rheumatoid Arthritis
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable rheumatoid-arthritis
Started Sep 2014
Longer than P75 for not_applicable rheumatoid-arthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 17, 2014
CompletedFirst Posted
Study publicly available on registry
September 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedMay 23, 2022
May 1, 2022
10 years
September 17, 2014
May 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Time to Death Due to Any Cause
Up to 5 years
Time to Non-cardiovascular Death
Up to 5 years
Time to Serious Adverse Event (hospitalizations)
Up to 5 years
The proportion of patients having a treatment success
1, 2 and 5 years
Study Arms (2)
Intervention
OTHERIn the intervention group all patients will receive statins according to national guidelines. Stepwise introduction of pharmacological therapy targeting 1) hyperlipidaemia, 2) hypertension, 3) hyperglycaemia and 4) microalbuminuria and behaviour modification will be controlled by the project team in an outpatient rheumatology department. Hyperlipidaemia: LDL \> 2.5 is treated with 40 mg Simvastatin; Hypertension: BT \> 140/90 mmHg treated with 100 mg OD Losartan; Diabetes: DM BT \> 130/80 mmHg treated with 100 mg OD Losartan; Microalbuminuria: Urinary albumin creatinin ratio \> 30 mg treated with 100 mg OD Losartan; Hyperglycaemia: HBA1C \> 48 mmol/mol treated with 500 mg increased dose to 2,000 mg in 4 weeks Metformin
Control
OTHERIn the control group patients will be refered to general practice for pharmacological therapy according to national guidelines targeting 1) hyperlipidaemia, 2) hypertension, 3) hyperglycaemia and 4) microalbuminuria. Hyperlipidaemia: LDL \> 2.5 is treated with 40 mg Simvastatin; Hypertension: BT \> 140/90 mmHg treated with 100 mg OD Losartan; Diabetes: DM BT \> 130/80 mmHg treated with 100 mg OD Losartan; Microalbuminuria: Urinary albumin creatinin ratio \> 30 mg treated with 100 mg OD Losartan; Hyperglycaemia: HBA1C \> 48 mmol/mol treated with 500 mg increased dose to 2,000 mg in 4 weeks Metformin
Interventions
HBA1C \> 48 mmol/mol treated with 500 mg increased dose to 2,000 mg in 4 weeks
Eligibility Criteria
You may qualify if:
- RA according to the revised American College of Rheumatology (ACR) 2010 criteria and plasma LDL \> 2.5mmol/l.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Rheumathology, Frederiksberg and Bispebjerg univeristy Hospital
Frederiksberg, Region of Copenhagen, 2000, Denmark
Related Publications (1)
Svensson AL, Christensen R, Persson F, Logstrup BB, Giraldi A, Graugaard C, Fredberg U, Blegvad J, Thygesen T, Hansen IM, Colic A, Bagdat D, Ahlquist P, Jensen HS, Horslev-Petersen K, Sheetal E, Christensen TG, Svendsen L, Emmertsen H, Ellingsen T. Multifactorial intervention to prevent cardiovascular disease in patients with early rheumatoid arthritis: protocol for a multicentre randomised controlled trial. BMJ Open. 2016 Apr 20;6(4):e009134. doi: 10.1136/bmjopen-2015-009134.
PMID: 27098820DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Torkell J Ellingsen, MD, PhD
Odense University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
September 17, 2014
First Posted
September 22, 2014
Study Start
September 1, 2014
Primary Completion
September 1, 2024
Study Completion
September 1, 2024
Last Updated
May 23, 2022
Record last verified: 2022-05