Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2020-11-24
2022-02-01
Brief Summary
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Detailed Description
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Objective: The objective of the Urica Cor Intervention (URICORI) trial is to evaluate the effectiveness of a one-year, intervention of modifiable risk factors for CVD administered in a rheumatology outpatient clinical setting, compared with conventional treatment for modifiable risk factors for CVD in people with gout.
Design: The study is a randomised, open label, blinded endpoint trial, with balanced randomisation (1:1) conducted in four rheumatology outpatient clinics in Denmark. The investigators aim to recruit 266 people with gout, fulfilling the current EULAR ( European League against Rheumatism)/ ACR (American College of Rheumatology) gout classification criteria. Eligible patients will be randomised to receive either conventional (control group) treatment for CVD risk factors administered by their general practitioner according to national guidelines (NG) versus the URICORI programme, administered at the rheumatology department, targeting the same CVD risk factors according to NG. Both groups will be treated for gout at their local department of rheumatology.
End Points: primary end point is a composite endpoint. By inclusion in the URICORI programme all participants will be considered a member of one of four categories derived from the Systematic Coronary Risk Estimation (SCORE) screening programme designed to assess the 10 year risk of fatal cardiovascular disease in European low risk population. As a consequence, participants will be classified as responder after 12 months if all national treatment targets for LDL cholesterol, HbA1c, Blood pressure (systolic and diastolic), according to their SCORE risk profile, is met and no commencement of smoking. If not, participants will be classified as non-responders.
Key secondary end points: Change from baseline of LDL cholesterol, HbA1c, systolic blood pressure, diastolic blood pressure, smoking status and change from baseline in serum urate. Exploratory end points: Proportion of participants achieving treatment target for LDL cholesterol, HbA1c, systolic blood pressure, diastolic blood pressure, change in smoking status (commencement and cessation) and proportion of participants achieving serum urate \< 36.0 mmol/l or serum urate \< 0.30 mmol/l for tophaceous disease.
After year 1 and year 5, the first occurrence of any serious cardiovascular event (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke or urgent revascularization due to unstable angina) during the URICORI trial will be registered. Death and hospitalisation during the URICORI trial will also be evaluated after year 5. Events will be determined by medical record review and evaluated by the endpoint adjudication committee. The Outcome Measures in Rheumatology (OMERACT) endorsed Core Domain Set for us in trials in gout will measured during and after the one-year URICORI intervention trial.
Ethics and dissemination: The local ethics committee in the region of southern Denmark and the Danish data agency in the region of southern Denmark will approve this protocol prior to commencement.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Management by Rheumatologist
Treatment of modifiable risk factors for cardiovascular disease managed by the Rheumatologist according to national guideline.
URICORI
Treatment for cardiovascular risk factors according to national guideline administered at the department of Rheumatology
Management by General Practitioner
Treatment of modifiable risk factors for cardiovascular disease managed by the General Practitioner according to national guideline.
CONTROL
Treatment for cardiovascular risk factors according to national guideline administered at the General Practitioner
Interventions
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URICORI
Treatment for cardiovascular risk factors according to national guideline administered at the department of Rheumatology
CONTROL
Treatment for cardiovascular risk factors according to national guideline administered at the General Practitioner
Eligibility Criteria
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Inclusion Criteria
* Age \>18 years
* Plasma LDL \>3.0 mmol/L
* Agreeable to start treatment for CVD risk factors if indicated
* Ability to give informed consent
* Ability to communicate via telephone
Exclusion Criteria
* Age \>70 years.
* Active cancer (in active treatment).
* Chronic kidney disease (eGFR \<30 ml/min/1.73m2).
* People whose behaviour or lifestyle would render them less likely to comply with the study protocol (i.e., abuse of alcohol, substance misuse or debilitating psychiatric conditions).
* Familial hypercholesterolemia.
18 Years
70 Years
ALL
No
Sponsors
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Odense University Hospital
OTHER
Frederiksberg University Hospital
OTHER
Oak Foundation
OTHER
The Danish Rheumatism Association
OTHER
Region of Southern Denmark
OTHER
University of Southern Denmark
OTHER
Torkell Ellingsen
OTHER
Responsible Party
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Torkell Ellingsen
Professor
Principal Investigators
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Melanie Morillon, MD
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Locations
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Odense University Hospital
Odense, , Denmark
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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OL10224607
Identifier Type: -
Identifier Source: org_study_id
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