<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/NCT03770312</url>
  </required_header>
  <id_info>
    <org_study_id>4-2019-1219</org_study_id>
    <nct_id>NCT03770312</nct_id>
  </id_info>
  <brief_title>Low- and Moderate-intensity Statin and Clinical Outcome of Primary Prevention in Individuals Aged &gt;75 Years: the SCOPE-75 RCT Study</brief_title>
  <official_title>Low- and Moderate-intensity Statin and Clinical Outcome of Primary Prevention in Individuals Aged &gt;75 Years: the SCOPE-75 RCT Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</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>
      One of the most effective drug in the primary prevention of cardiovascular disease is&#xD;
      statins. The protective effects of statin on developement of cardiovascular disease has been&#xD;
      demonstrated in elderly individuals aged over 75 years. Since side effects of statin are more&#xD;
      common in elderly individuals than in younger individuals, clinical guidelines recommend that&#xD;
      use of low intensity statin is considered in elderly individuals. However, there are few&#xD;
      randomized clinical trials evaluating the safety and efficacy of different intensity statins&#xD;
      in elderly individuals.&#xD;
&#xD;
      This is a multicenter, prospective, randomized clinical trial to compare efficacy and safety&#xD;
      between low and high intensity statin for primary prevention of cardiovascular disease in&#xD;
      elderly individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Healthy elderly individuals who are eligible to use of statin for primary prevention will be&#xD;
      enrolled. They are randomly assigned to moderate intensity statin group and low intensity&#xD;
      statin group by 1:1 manner. Blood tests, physical examinations, and evaluation of statin&#xD;
      associated muscle symptoms are conducted every 3 months after enrollment. General medical&#xD;
      care for prevention of cardiovascular disease is continued after 6 months. The accrual period&#xD;
      is 2 years and follow-up period is 4 years, so the total study period is 6 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">March 5, 2020</start_date>
  <completion_date type="Anticipated">January 16, 2026</completion_date>
  <primary_completion_date type="Anticipated">January 16, 2026</primary_completion_date>
  <phase>Phase 4</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Statin associated muscle symptoms (SAMS) -If all of the following occur, it is defined as SAMS.</measure>
    <time_frame>3 months</time_frame>
    <description>They report new or increased myalgia, cramps, or muscle aching, unassociated with recent exercise.&#xD;
These symptoms have persisted for at least 2 weeks.&#xD;
The symptoms resolve within 2 weeks of stopping the study drug.&#xD;
The symptoms reoccur within 4 weeks of restarting the medication.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Statin associated muscle symptoms (SAMS) -If all of the following occur, it is defined as SAMS.</measure>
    <time_frame>6 months</time_frame>
    <description>They report new or increased myalgia, cramps, or muscle aching, unassociated with recent exercise.&#xD;
These symptoms have persisted for at least 2 weeks.&#xD;
The symptoms resolve within 2 weeks of stopping the study drug.&#xD;
The symptoms reoccur within 4 weeks of restarting the medication.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form Brief Pain Inventory (BPI-SF).</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form Brief Pain Inventory (BPI-SF).</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form McGill Pain Questionnaire (SF-MPQ)</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form McGill Pain Questionnaire (SF-MPQ)</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical outcomes</measure>
    <time_frame>4 years</time_frame>
    <description>cardiovascular death&#xD;
nonfatal myocardial infarction&#xD;
nonfatal ischemic stroke or transient ischemic attack&#xD;
coronary revascularization (percutaneous coronary intervention, coronary artery bypass graft)&#xD;
hospitalization for unstable angina</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2484</enrollment>
  <condition>Healthy Elderly Individuals With High LDL-cholesterol or Risk of Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>Low intensity statin group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Taking low intensity statin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate intensity statin group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Taking moderate intensity statin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low intensity statin</intervention_name>
    <description>Use of low intensity statin for primary prevention of cardiovascular disease.</description>
    <arm_group_label>Low intensity statin group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Moderate intensity statin</intervention_name>
    <description>Use of moderate intensity statin for primary prevention of cardiovascular disease.</description>
    <arm_group_label>Moderate intensity statin group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: (1 and, 2 or 3)&#xD;
&#xD;
          1. Individuals aged 76-85 years old.&#xD;
&#xD;
          2. Individuals who have serum LDL-cholesterol of 160-189 mg/dL.&#xD;
&#xD;
          3. Individuals who have serum LDL-cholesterol of 80-159 mg/dL and ≥1 cardiovascular risk&#xD;
             factor (male, diabetes, hypertension, smoking, serum HDL-cholesterol &lt;40 mg/dL, or&#xD;
             family history of premature cardiovascular disease).&#xD;
&#xD;
        Exclusion Criteria: (any)&#xD;
&#xD;
          1. Individuals who have been diagnosed with cancer within the last 5 years.&#xD;
&#xD;
          2. Individuals who have high level of serum aspartate aminotransferase (AST), alanine&#xD;
             amino- transferse (ALT) (&gt;2 upper normal limit).&#xD;
&#xD;
          3. past history of myopathy or rhabdomyolysis or Creatine Kinase (CK)&gt; 2-fold of upper&#xD;
             normal limit&#xD;
&#xD;
          4. Individuals who have serum creatinine ≥2 mg/dL.&#xD;
&#xD;
          5. Individuals who have been diagnosed with cardiovascular disease (&gt;50% stenosis of&#xD;
             coronary artery on imaging study, percutaneous transluminal coronary angioplasty,&#xD;
             coronary artery bypass graft, or myocardial infarction).&#xD;
&#xD;
          6. Individuals who have been diagnosed with peripheral artery disease (&gt;50% stenosis of&#xD;
             peripheral artery on imaging study, or ankle brachial index &lt;0.9 or ≥1.3).&#xD;
&#xD;
          7. Individuals who have been diagnosed with hyperthyroidism or hypothyroidism.&#xD;
&#xD;
          8. Individuals who are taking drug that can interact with statin.&#xD;
&#xD;
          9. Individuals who have physical disability to live daily life.&#xD;
&#xD;
         10. genetic disorder such as galactose intolerance, etc&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>76 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Division of Cardiology, Cardiovascular Center, Severance Hospital, Yonsei University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <contact>
      <last_name>Sang-Hak Lee, MD</last_name>
      <phone>82-2-2228-8460</phone>
      <email>SHL1106@yuhs.ac</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>February 4, 2020</last_update_submitted>
  <last_update_submitted_qc>February 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydroxymethylglutaryl-CoA Reductase Inhibitors</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03770312
org study id: 4-2019-1219
nct id: NCT03770312
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
One of the most effective drug in the primary prevention of cardiovascular disease is
      statins. The protective effects of statin on developement of cardiovascular disease has been
      demonstrated in elderly individuals aged over 75 years. Since side effects of statin are more
      common in elderly individuals than in younger individuals, clinical guidelines recommend that
      use of low intensity statin is considered in elderly individuals. However, there are few
      randomized clinical trials evaluating the safety and efficacy of different intensity statins
      in elderly individuals.

      This is a multicenter, prospective, randomized clinical trial to compare efficacy and safety
      between low and high intensity statin for primary prevention of cardiovascular disease in
      elderly individuals.
Healthy elderly individuals who are eligible to use of statin for primary prevention will be
      enrolled. They are randomly assigned to moderate intensity statin group and low intensity
      statin group by 1:1 manner. Blood tests, physical examinations, and evaluation of statin
      associated muscle symptoms are conducted every 3 months after enrollment. General medical
      care for prevention of cardiovascular disease is continued after 6 months. The accrual period
      is 2 years and follow-up period is 4 years, so the total study period is 6 years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Statin associated muscle symptoms (SAMS) -If all of the following occur, it is defined as SAMS.
time frame: 3 months
description: They report new or increased myalgia, cramps, or muscle aching, unassociated with recent exercise.
These symptoms have persisted for at least 2 weeks.
The symptoms resolve within 2 weeks of stopping the study drug.
The symptoms reoccur within 4 weeks of restarting the medication.
measure: Statin associated muscle symptoms (SAMS) -If all of the following occur, it is defined as SAMS.
time frame: 6 months
description: They report new or increased myalgia, cramps, or muscle aching, unassociated with recent exercise.
These symptoms have persisted for at least 2 weeks.
The symptoms resolve within 2 weeks of stopping the study drug.
The symptoms reoccur within 4 weeks of restarting the medication.
measure: Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form Brief Pain Inventory (BPI-SF).
time frame: 3 months
measure: Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form Brief Pain Inventory (BPI-SF).
time frame: 6 months
measure: Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form McGill Pain Questionnaire (SF-MPQ)
time frame: 3 months
measure: Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form McGill Pain Questionnaire (SF-MPQ)
time frame: 6 months
measure: Clinical outcomes
time frame: 4 years
description: cardiovascular death
nonfatal myocardial infarction
nonfatal ischemic stroke or transient ischemic attack
coronary revascularization (percutaneous coronary intervention, coronary artery bypass graft)
hospitalization for unstable angina
arm group label: Low intensity statin group
arm group type: Active Comparator
description: Taking low intensity statin
arm group label: Moderate intensity statin group
arm group type: Active Comparator
description: Taking moderate intensity statin
intervention type: Drug
intervention name: Low intensity statin
description: Use of low intensity statin for primary prevention of cardiovascular disease.
arm group label: Low intensity statin group
intervention type: Drug
intervention name: Moderate intensity statin
description: Use of moderate intensity statin for primary prevention of cardiovascular disease.
arm group label: Moderate intensity statin group
criteria: 
gender: All
minimum age: 76 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Hydroxymethylglutaryl-CoA Reductase Inhibitors
sharing ipd: No