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Early Rheumatoid Arthritis COR Intervention (ERACORI)

Primary Purpose

Rheumatoid Arthritis, Cardiovascular Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Simvastatin
Losartan
Losartan
Losartan
Metformin
Outpatient rheumatology department
Refered to general practice
Sponsored by
MD, PhD, Annemarie Lyng Svensson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Department of Rheumathology, Frederiksberg and Bispebjerg univeristy HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Intervention

Control

Arm Description

In 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

In 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
Time to Serious Adverse Event (hospitalizations)
Time from randomization to the first venous thromboembolic event. Kaplan-Meier estimate of the mean
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

Full Information

First Posted
September 17, 2014
Last Updated
May 20, 2022
Sponsor
MD, PhD, Annemarie Lyng Svensson
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1. Study Identification

Unique Protocol Identification Number
NCT02246257
Brief Title
Early Rheumatoid Arthritis COR Intervention
Acronym
ERACORI
Official Title
Multifactorial Intervention to Prevent Cardiovascular Disease in Patients With Early Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
MD, PhD, Annemarie Lyng Svensson

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Cardiovascular Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Other
Arm Description
In 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
Arm Title
Control
Arm Type
Other
Arm Description
In 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
Intervention Type
Other
Intervention Name(s)
Simvastatin
Other Intervention Name(s)
Hyperlipidaemia
Intervention Description
LDL > 2.5 is treated with 40 mg
Intervention Type
Other
Intervention Name(s)
Losartan
Other Intervention Name(s)
Hypertension
Intervention Description
BT > 140/90 mmHg treated with 50 mg OD
Intervention Type
Other
Intervention Name(s)
Losartan
Other Intervention Name(s)
Diabetes
Intervention Description
DM BT > 130/80 mmHg treated with 50 mg OD
Intervention Type
Other
Intervention Name(s)
Losartan
Other Intervention Name(s)
Microalbuminuria
Intervention Description
Microalbuminuria (urinary albumin creatinin ratio > 30 mg) treated with 100 mg OD
Intervention Type
Other
Intervention Name(s)
Metformin
Other Intervention Name(s)
Hyperglycaemia
Intervention Description
HBA1C > 48 mmol/mol treated with 500 mg increased dose to 2,000 mg in 4 weeks
Intervention Type
Other
Intervention Name(s)
Outpatient rheumatology department
Other Intervention Name(s)
Intervention
Intervention Description
(4 times yearly)
Intervention Type
Other
Intervention Name(s)
Refered to general practice
Other Intervention Name(s)
Control
Primary Outcome Measure Information:
Title
Time to Major Cardiac Event (death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke and cardiac revascularization)
Description
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.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Time to Death Due to Any Cause
Description
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
Time Frame
Up to 5 years
Title
Time to Non-cardiovascular Death
Description
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
Time Frame
Up to 5 years
Title
Time to Serious Adverse Event (hospitalizations)
Description
Time from randomization to the first venous thromboembolic event. Kaplan-Meier estimate of the mean
Time Frame
Up to 5 years
Title
The proportion of patients having a treatment success
Description
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
Time Frame
1, 2 and 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annemarie L Svensson, MD, PhD
Phone
+45 28 555 126
Email
lyng.annemarie@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Torkell J Ellingsen, MD, PhD
Phone
+45 6541 1814
Email
torkell.ellingsen@rsyd.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torkell J Ellingsen, MD, PhD
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rheumathology, Frederiksberg and Bispebjerg univeristy Hospital
City
Frederiksberg
State/Province
Region Of Copenhagen
ZIP/Postal Code
2000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annemarie Lyng Svesson, MD, PhD
Phone
004528555126
Email
lyng.annemarie@gmail.com
First Name & Middle Initial & Last Name & Degree
Torkell J Ellingsen, MD, PhD, Professor
Phone
004565413523
Email
torkell.ellingsen@rsyd.dk

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27098820
Citation
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.
Results Reference
derived

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Early Rheumatoid Arthritis COR Intervention

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