<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04459936</url>
  </required_header>
  <id_info>
    <org_study_id>OL10224607</org_study_id>
    <nct_id>NCT04459936</nct_id>
  </id_info>
  <brief_title>Urica Cor Intervention (URICORI) Trial</brief_title>
  <acronym>URICORI</acronym>
  <official_title>A Multifactorial 'Urica Cor Intervention' to Prevent Cardiovascular Disease in People With Gout: Protocol for the Multicentre, Randomised Controlled, Blinded Endpoint URICORI Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Torkell Ellingsen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Frederiksberg University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oak Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Danish Rheumatism Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Region of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Odense University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the Urica Cor Intervention (URICORI) trial is to evaluate the effectiveness&#xD;
      of a one-year, intervention of modifiable risk factors for CVD administered in a rheumatology&#xD;
      outpatient clinical setting, compared with conventional treatment for modifiable risk factors&#xD;
      for CVD in people with gout.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction: Gout has been associated with a number of comorbidities including&#xD;
      cardiovascular disease (CVD). Mounting evidence suggests that hyperuricaemia and gout are&#xD;
      associated with a high risk for CVD. Gout is closely related to hypertension, dyslipidaemia,&#xD;
      obesity and metabolic syndrome, all well-known factors contributing to the development of&#xD;
      CVD. Gout management guidelines all agree that comorbidity screening is relevant and thus&#xD;
      should be implemented in contemporary gout management. However, no specific strategy for&#xD;
      management of CVD risk factors, in a gout population, exists.&#xD;
&#xD;
      Objective: The objective of the Urica Cor Intervention (URICORI) trial is to evaluate the&#xD;
      effectiveness of a one-year, intervention of modifiable risk factors for CVD administered in&#xD;
      a rheumatology outpatient clinical setting, compared with conventional treatment for&#xD;
      modifiable risk factors for CVD in people with gout.&#xD;
&#xD;
      Design: The study is a randomised, open label, blinded endpoint trial, with balanced&#xD;
      randomisation (1:1) conducted in four rheumatology outpatient clinics in Denmark. The&#xD;
      investigators aim to recruit 266 people with gout, fulfilling the current EULAR ( European&#xD;
      League against Rheumatism)/ ACR (American College of Rheumatology) gout classification&#xD;
      criteria. Eligible patients will be randomised to receive either conventional (control group)&#xD;
      treatment for CVD risk factors administered by their general practitioner according to&#xD;
      national guidelines (NG) versus the URICORI programme, administered at the rheumatology&#xD;
      department, targeting the same CVD risk factors according to NG. Both groups will be treated&#xD;
      for gout at their local department of rheumatology.&#xD;
&#xD;
      End Points: primary end point is a composite endpoint. By inclusion in the URICORI programme&#xD;
      all participants will be considered a member of one of four categories derived from the&#xD;
      Systematic Coronary Risk Estimation (SCORE) screening programme designed to assess the 10&#xD;
      year risk of fatal cardiovascular disease in European low risk population. As a consequence,&#xD;
      participants will be classified as responder after 12 months if all national treatment&#xD;
      targets for LDL cholesterol, HbA1c, Blood pressure (systolic and diastolic), according to&#xD;
      their SCORE risk profile, is met and no commencement of smoking. If not, participants will be&#xD;
      classified as non-responders.&#xD;
&#xD;
      Key secondary end points: Change from baseline of LDL cholesterol, HbA1c, systolic blood&#xD;
      pressure, diastolic blood pressure, smoking status and change from baseline in serum urate.&#xD;
      Exploratory end points: Proportion of participants achieving treatment target for LDL&#xD;
      cholesterol, HbA1c, systolic blood pressure, diastolic blood pressure, change in smoking&#xD;
      status (commencement and cessation) and proportion of participants achieving serum urate &lt;&#xD;
      36.0 mmol/l or serum urate &lt; 0.30 mmol/l for tophaceous disease.&#xD;
&#xD;
      After year 1 and year 5, the first occurrence of any serious cardiovascular event&#xD;
      (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke or urgent&#xD;
      revascularization due to unstable angina) during the URICORI trial will be registered. Death&#xD;
      and hospitalisation during the URICORI trial will also be evaluated after year 5. Events will&#xD;
      be determined by medical record review and evaluated by the endpoint adjudication committee.&#xD;
      The Outcome Measures in Rheumatology (OMERACT) endorsed Core Domain Set for us in trials in&#xD;
      gout will measured during and after the one-year URICORI intervention trial.&#xD;
&#xD;
      Ethics and dissemination: The local ethics committee in the region of southern Denmark and&#xD;
      the Danish data agency in the region of southern Denmark will approve this protocol prior to&#xD;
      commencement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The study has been terminated due to inclusion difficulties during the worldwide Covid-19&#xD;
    pandemic.&#xD;
  </why_stopped>
  <start_date type="Actual">November 24, 2020</start_date>
  <completion_date type="Actual">February 1, 2022</completion_date>
  <primary_completion_date type="Actual">February 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The study is a randomised, open label, blinded endpoint trial, with balanced randomisation (1:1)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Responders (Dichotomised: responder/non-responder)</measure>
    <time_frame>1 year from inclusion</time_frame>
    <description>Primary end point is a composite endpoint. By inclusion in the URICORI trial 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, range 0-24%). 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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>LDL Cholesterol</measure>
    <time_frame>1 year from inclusion</time_frame>
    <description>Change from baseline of LDL Cholesterol (mmol/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c</measure>
    <time_frame>1 year from inclusion</time_frame>
    <description>Change from baseline of HbA1c (mmol/mol).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic blood pressure</measure>
    <time_frame>1 year from inclusion</time_frame>
    <description>Change from baseline Systolic blood pressure (mmHg).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic blood pressure Change from baseline Diastolic blood pressure (mmHg).</measure>
    <time_frame>1 year from inclusion</time_frame>
    <description>Change from baseline Diastolic blood pressure (mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smoking</measure>
    <time_frame>1 year from inclusion</time_frame>
    <description>Change in smoking status (dichotomised yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Urate</measure>
    <time_frame>1 year from inclusion</time_frame>
    <description>Change from baseline in serum urate (mmol/L)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>LDL cholesterol</measure>
    <time_frame>1 and 5 years from inclusion</time_frame>
    <description>Proportion of participants achieving treatment target for LDL cholesterol (mmol/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>HbA1c</measure>
    <time_frame>1 and 5 years from inclusion</time_frame>
    <description>Proportion of participants achieving HbA1c (mmol/mol) treatment target.</description>
  </other_outcome>
  <other_outcome>
    <measure>Systolic blood pressure</measure>
    <time_frame>1 and 5 years from inclusion</time_frame>
    <description>Proportion of participants achieving treatment target for systolic blood pressure (mmHg)</description>
  </other_outcome>
  <other_outcome>
    <measure>Diastolic blood pressure</measure>
    <time_frame>1 and 5 years from inclusion</time_frame>
    <description>Proportion of participants achieving treatment target for diastolic blood pressure (mmHg)</description>
  </other_outcome>
  <other_outcome>
    <measure>Smoking</measure>
    <time_frame>1 and 5 years from inclusion</time_frame>
    <description>Proportion of participants with change in smoking status (commencement and cessation)</description>
  </other_outcome>
  <other_outcome>
    <measure>Serum urate</measure>
    <time_frame>1 and 5 years from inclusion</time_frame>
    <description>Proportion of participants achieving serum urate &lt; 36.0 mmol/l or if tophaceous disease serum urate &lt; 0.30 mmol/l</description>
  </other_outcome>
  <other_outcome>
    <measure>Cardiovascular event</measure>
    <time_frame>1 year form inclusion</time_frame>
    <description>Proportion of participants with any serious cardiovascular event during the first year of the URICORI trial.</description>
  </other_outcome>
  <other_outcome>
    <measure>Serious cardiovascular event</measure>
    <time_frame>5 years from inclusion</time_frame>
    <description>Proportion of patients with any serious cardiovascular event during the 5-year URICORI trial. (serious cardiovascular event: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or urgent revascularization due to unstable angina)</description>
  </other_outcome>
  <other_outcome>
    <measure>Death</measure>
    <time_frame>5 years from inclusion</time_frame>
    <description>Death from any cause (death will be classified as due to either cardiovascular or non-cardiovascular)</description>
  </other_outcome>
  <other_outcome>
    <measure>Hospitalisation</measure>
    <time_frame>5 years from inclusion</time_frame>
    <description>Hospitalisation due to elective or acute cardiovascular reasons during the URICORI trial.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Gout</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Dyslipidemias</condition>
  <condition>Hypertension</condition>
  <condition>Diabetes</condition>
  <condition>Behavior, Smoking</condition>
  <arm_group>
    <arm_group_label>Management by Rheumatologist</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment of modifiable risk factors for cardiovascular disease managed by the Rheumatologist according to national guideline.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Management by General Practitioner</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment of modifiable risk factors for cardiovascular disease managed by the General Practitioner according to national guideline.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>URICORI</intervention_name>
    <description>Treatment for cardiovascular risk factors according to national guideline administered at the department of Rheumatology</description>
    <arm_group_label>Management by Rheumatologist</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CONTROL</intervention_name>
    <description>Treatment for cardiovascular risk factors according to national guideline administered at the General Practitioner</description>
    <arm_group_label>Management by General Practitioner</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gout according to current EULAR/ACR (American College of Rheumatology) gout&#xD;
             classification criteria&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
          -  Plasma LDL &gt;3.0 mmol/L&#xD;
&#xD;
          -  Agreeable to start treatment for CVD risk factors if indicated&#xD;
&#xD;
          -  Ability to give informed consent&#xD;
&#xD;
          -  Ability to communicate via telephone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other inflammatory diseases requiring immunosuppressant therapy.&#xD;
&#xD;
          -  Age &gt;70 years.&#xD;
&#xD;
          -  Active cancer (in active treatment).&#xD;
&#xD;
          -  Chronic kidney disease (eGFR &lt;30 ml/min/1.73m2).&#xD;
&#xD;
          -  People whose behaviour or lifestyle would render them less likely to comply with the&#xD;
             study protocol (i.e., abuse of alcohol, substance misuse or debilitating psychiatric&#xD;
             conditions).&#xD;
&#xD;
          -  Familial hypercholesterolemia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melanie Morillon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Odense University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>May 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>May 19, 2022</last_update_submitted>
  <last_update_submitted_qc>May 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>Torkell Ellingsen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Dyslipidemias</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>If other research groups could benefit from the IPD (individual patient data ), the data will be shared after individual evaluation by the trial sponsor.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 23, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT04459936/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04459936
org study id: OL10224607
nct id: NCT04459936
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
Introduction: Gout has been associated with a number of comorbidities including
      cardiovascular disease (CVD). Mounting evidence suggests that hyperuricaemia and gout are
      associated with a high risk for CVD. Gout is closely related to hypertension, dyslipidaemia,
      obesity and metabolic syndrome, all well-known factors contributing to the development of
      CVD. Gout management guidelines all agree that comorbidity screening is relevant and thus
      should be implemented in contemporary gout management. However, no specific strategy for
      management of CVD risk factors, in a gout population, exists.

      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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study is a randomised, open label, blinded endpoint trial, with balanced randomisation (1:1)
primary purpose: Treatment
masking: None (Open Label)
measure: Responders (Dichotomised: responder/non-responder)
time frame: 1 year from inclusion
description: Primary end point is a composite endpoint. By inclusion in the URICORI trial 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, range 0-24%). 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.
measure: LDL Cholesterol
time frame: 1 year from inclusion
description: Change from baseline of LDL Cholesterol (mmol/L)
measure: HbA1c
time frame: 1 year from inclusion
description: Change from baseline of HbA1c (mmol/mol).
measure: Systolic blood pressure
time frame: 1 year from inclusion
description: Change from baseline Systolic blood pressure (mmHg).
measure: Diastolic blood pressure Change from baseline Diastolic blood pressure (mmHg).
time frame: 1 year from inclusion
description: Change from baseline Diastolic blood pressure (mmHg)
measure: Smoking
time frame: 1 year from inclusion
description: Change in smoking status (dichotomised yes/no)
measure: Serum Urate
time frame: 1 year from inclusion
description: Change from baseline in serum urate (mmol/L)
measure: LDL cholesterol
time frame: 1 and 5 years from inclusion
description: Proportion of participants achieving treatment target for LDL cholesterol (mmol/L)
measure: HbA1c
time frame: 1 and 5 years from inclusion
description: Proportion of participants achieving HbA1c (mmol/mol) treatment target.
measure: Systolic blood pressure
time frame: 1 and 5 years from inclusion
description: Proportion of participants achieving treatment target for systolic blood pressure (mmHg)
measure: Diastolic blood pressure
time frame: 1 and 5 years from inclusion
description: Proportion of participants achieving treatment target for diastolic blood pressure (mmHg)
measure: Smoking
time frame: 1 and 5 years from inclusion
description: Proportion of participants with change in smoking status (commencement and cessation)
measure: Serum urate
time frame: 1 and 5 years from inclusion
description: Proportion of participants achieving serum urate < 36.0 mmol/l or if tophaceous disease serum urate < 0.30 mmol/l
measure: Cardiovascular event
time frame: 1 year form inclusion
description: Proportion of participants with any serious cardiovascular event during the first year of the URICORI trial.
measure: Serious cardiovascular event
time frame: 5 years from inclusion
description: Proportion of patients with any serious cardiovascular event during the 5-year URICORI trial. (serious cardiovascular event: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or urgent revascularization due to unstable angina)
measure: Death
time frame: 5 years from inclusion
description: Death from any cause (death will be classified as due to either cardiovascular or non-cardiovascular)
measure: Hospitalisation
time frame: 5 years from inclusion
description: Hospitalisation due to elective or acute cardiovascular reasons during the URICORI trial.
arm group label: Management by Rheumatologist
arm group type: Experimental
description: Treatment of modifiable risk factors for cardiovascular disease managed by the Rheumatologist according to national guideline.
arm group label: Management by General Practitioner
arm group type: Active Comparator
description: Treatment of modifiable risk factors for cardiovascular disease managed by the General Practitioner according to national guideline.
intervention type: Other
intervention name: URICORI
description: Treatment for cardiovascular risk factors according to national guideline administered at the department of Rheumatology
arm group label: Management by Rheumatologist
intervention type: Other
intervention name: CONTROL
description: Treatment for cardiovascular risk factors according to national guideline administered at the General Practitioner
arm group label: Management by General Practitioner
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Melanie Morillon, MD
role: Principal Investigator
affiliation: Odense University Hospital
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: Odense University Hospital
investigator full name: Torkell Ellingsen
investigator title: Professor
mesh term: Cardiovascular Diseases
mesh term: Dyslipidemias
sharing ipd: No
ipd description: If other research groups could benefit from the IPD (individual patient data ), the data will be shared after individual evaluation by the trial sponsor.
provided document: 