<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/NCT02970084</url>
  </required_header>
  <id_info>
    <org_study_id>PLAK2/74/OSR</org_study_id>
    <nct_id>NCT02970084</nct_id>
  </id_info>
  <brief_title>Vitamin K2 for Reduction the Calcium at Carotid Bifurcation in Patients With Subcritical Lesions</brief_title>
  <official_title>Role of Vitamin K2 in the Reduction of the Calcium Content at the Level of the Carotid Bifurcation in Patients With Subcritical Lesions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Scientific Institute San Raffaele</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Scientific Institute San Raffaele</source>
  <brief_summary>
    <textblock>
      Clinical study single center, prospective, randomized, controlled (vs. no supplement),&#xD;
      open-label, blinded assessor (the doctor who will perform the Doppler ultrasound at 6 and 12&#xD;
      months will not know the treatment given to the patient, because the diagnostic test in&#xD;
      question is considered operator-dependent), a &quot;parallel group&quot;, which aims is evaluate the&#xD;
      reduction in the level of calcium in the carotid artery and the carotid atherosclerotic&#xD;
      plaques, on a sample of 60 subjects presenting subcritical calcified lesions of the carotid&#xD;
      bifurcation with a range of 40-60%.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">May 2019</completion_date>
  <primary_completion_date type="Actual">May 2019</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of calcium content, to 12 months, at the level of carotid atheromatous plaque</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Carotid Plaques</condition>
  <arm_group>
    <arm_group_label>Group with K2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The nutraceutical product (PLAK2) based on vitamin K2, will be administered once a day (a tablet 800mg) for 12 months.&#xD;
All patients enrolled will continue to be treated according to the clinical standard (100 mg Cardioaspirin, cp 1 day : Acetylsalicylic acid)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group (no vitamin K2)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group did not take the supplement of Vitamin K2. All patients enrolled will continue to be treated according to the clinical standard (100 mg Cardioaspirin, cp 1 day : Acetylsalicylic acid)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nutraceutical product based on vitamin K2 (PLAK2)</intervention_name>
    <arm_group_label>Group with K2</arm_group_label>
    <other_name>PLAK2</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years&#xD;
&#xD;
          2. Ability to provide written informed consent&#xD;
&#xD;
          3. subjects with calcified lesions subcritical from the carotid bifurcation. with a range&#xD;
             of 40-60% calculated method with ECTS (European Carotid Surgery Trial)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with reduced life expectancy or age&gt; 80 years,&#xD;
&#xD;
          2. Patients already subjected to other clinical trial in the previous three months,&#xD;
&#xD;
          3. Patients with hypersensitivity or with known allergies to acetylsalicylic acid,&#xD;
             patients with pre-existing mastocytosis, a history of asthma induced by salicylates,&#xD;
             duodenal ulcer, bleeding diathesis, severe hepatic insufficiency, severe heart&#xD;
             failure, concomitant treatment with methotrexate, last trimester of pregnancy.&#xD;
&#xD;
          4. Patients with known hypersensitivity to vitamin K2 and vitamin D, people with&#xD;
             hemolytic diseases, concomitant anticoagulant therapy, people with cancer, MAV&#xD;
             (arteriovenous malformations) and / or cerebral aneurysms, hypercalcemia,&#xD;
             nephrolithiasis and renal failure.&#xD;
&#xD;
          5. Uncooperative patients , or allergies related to the substance under study or with any&#xD;
             contra-indicated in the data sheet / Summary of Product Characteristics (SPC) of the&#xD;
             substances in the studio.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>San Raffaele Hospital</name>
      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>May 21, 2019</last_update_submitted>
  <last_update_submitted_qc>May 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Scientific Institute San Raffaele</investigator_affiliation>
    <investigator_full_name>yamume tshomba</investigator_full_name>
    <investigator_title>Medical doctor Associate Professor of Vascular Surgery</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin K</mesh_term>
    <mesh_term>Vitamin K 2</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02970084
org study id: PLAK2/74/OSR
nct id: NCT02970084
lead sponsor: 
Clinical study single center, prospective, randomized, controlled (vs. no supplement),
      open-label, blinded assessor (the doctor who will perform the Doppler ultrasound at 6 and 12
      months will not know the treatment given to the patient, because the diagnostic test in
      question is considered operator-dependent), a "parallel group", which aims is evaluate the
      reduction in the level of calcium in the carotid artery and the carotid atherosclerotic
      plaques, on a sample of 60 subjects presenting subcritical calcified lesions of the carotid
      bifurcation with a range of 40-60%.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: Reduction of calcium content, to 12 months, at the level of carotid atheromatous plaque
time frame: 12 months
arm group label: Group with K2
arm group type: Experimental
description: The nutraceutical product (PLAK2) based on vitamin K2, will be administered once a day (a tablet 800mg) for 12 months.
All patients enrolled will continue to be treated according to the clinical standard (100 mg Cardioaspirin, cp 1 day : Acetylsalicylic acid)
arm group label: Control group (no vitamin K2)
arm group type: No Intervention
description: The control group did not take the supplement of Vitamin K2. All patients enrolled will continue to be treated according to the clinical standard (100 mg Cardioaspirin, cp 1 day : Acetylsalicylic acid)
intervention type: Other
intervention name: Nutraceutical product based on vitamin K2 (PLAK2)
arm group label: Group with K2
other name: PLAK2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Scientific Institute San Raffaele
investigator full name: yamume tshomba
investigator title: Medical doctor Associate Professor of Vascular Surgery
mesh term: Vitamin K
mesh term: Vitamin K 2