<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/NCT02218476</url>
  </required_header>
  <id_info>
    <org_study_id>PI12-01511</org_study_id>
    <nct_id>NCT02218476</nct_id>
  </id_info>
  <brief_title>Beneficial Effects of Coenzyme Q10 Treatment on the Mitochondrial Dysfunction and Oxidative Stress Associated to Atherothrombosis Developement in Antiphospholipidid Syndrome Patients</brief_title>
  <acronym>coenzyme Q10</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Maimónides Biomedical Research Institute of Córdoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maimónides Biomedical Research Institute of Córdoba</source>
  <brief_summary>
    <textblock>
      The study will be performed on 50 APS (antiphospholipid Syndrome) patients, which will be&#xD;
      randomized to receive either CoQ10 (200mg/day) or placebo for one month. Blood will be drawn&#xD;
      at time 0 and at the end of the treatment. Studies will be conducted in plasma and purified&#xD;
      leukocytes from APS. Design: 1) Study of endothelial function: 2) Analysis of changes&#xD;
      operated on various prothrombotic/proinflammatory parameters and their associated&#xD;
      intracellular signalling. 3) Analysis of mitochondrial ultra structure and activity;&#xD;
      mitochondrial antioxidant system characterization; Expression levels and activity of&#xD;
      transcription factors/proteins involved in oxidative stress (Foxo 3, NFkB, Nrf2),&#xD;
      Quantification of CoQ10 (Coenzyme Q10). 4) Biomarkers of oxidative stress. 5) miRNAs&#xD;
      microarrays, RT-PCR validation and correlation/association studies. 6) Induction of&#xD;
      over-expression of miRNAs of interest; luciferase constructs. 7)Studies of methylation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2013</start_date>
  <primary_completion_date type="Anticipated">September 2016</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in endothelial function in vivo</measure>
    <time_frame>0 weeks, 4 weeks, 8weeks, 12weeks</time_frame>
    <description>Study of the endothelial function in vivo. Variations in capilar blood flow of the skin will be analyzed by noninvasive Doppler laser fluorimetry using a Periflux 5000 equipment.&#xD;
The study will be performed on 50 APS (antiphospholipid Syndrome) patients. Patients will be randomized to CoQ10 or placebo group. Treatments will be given for 1 month, according to a randomized and crossover design (with wash-out periods of four weeks) Blood will be drawn at time 0, at the end of treatment, and after three months of the end of treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Tissue factor</measure>
    <time_frame>0 weeks, 4 weeks, 8 weeks, 12 weeks</time_frame>
    <description>Parameters related to inflammation and thrombosis in cells measure at mRNA and VEGF (Vascular Endothelial Growth Factor) in serum/plasma and cells.&#xD;
The study will be performed on 50 APS (antiphospholipid Syndrome) patients. Patients will be randomized to CoQ10 or placebo group. Treatments will be given for 1 month, according to a randomized and crossover design (with wash-out periods of four weeks) Blood will be drawn at time 0, at the end of treatment, and after three months of the end of treatment.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment>50</enrollment>
  <condition>Coenzyme Q10 on Athero-thrombosis in APS Patients</condition>
  <arm_group>
    <arm_group_label>APS Patient</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CoQ10</intervention_name>
    <arm_group_label>APS Patient</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>APS Patient</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients who fulfilled Sidney criteria for APS (antiphospholipid Syndrome) (Miyakis S&#xD;
             et al., J Thromb Haemost 2006; 4:295-306)&#xD;
&#xD;
          2. Age over 18 years&#xD;
&#xD;
          3. Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Acute Liver Disease.&#xD;
&#xD;
          2. Severe renal impairment&#xD;
&#xD;
          3. Acute arterial or venous thrombosis episode in the last 3 months&#xD;
&#xD;
          4. Pregnancy and breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rosario Lopez Pedrera, Biology</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <overall_contact>
    <last_name>Maria de los Angeles Aguirre, Medicine</last_name>
    <phone>0034639410897</phone>
    <email>maaguirrezamorano@yahoo.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Universitario Reina Sofía de Córdoba</name>
      <address>
        <city>Cordoba</city>
        <state>Andalucía</state>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aguirre</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>August 14, 2014</last_update_submitted>
  <last_update_submitted_qc>August 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 18, 2014</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>Thrombosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coenzyme Q10</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/NCT02218476
org study id: PI12-01511
nct id: NCT02218476
lead sponsor: 
The study will be performed on 50 APS (antiphospholipid Syndrome) patients, which will be
      randomized to receive either CoQ10 (200mg/day) or placebo for one month. Blood will be drawn
      at time 0 and at the end of the treatment. Studies will be conducted in plasma and purified
      leukocytes from APS. Design: 1) Study of endothelial function: 2) Analysis of changes
      operated on various prothrombotic/proinflammatory parameters and their associated
      intracellular signalling. 3) Analysis of mitochondrial ultra structure and activity;
      mitochondrial antioxidant system characterization; Expression levels and activity of
      transcription factors/proteins involved in oxidative stress (Foxo 3, NFkB, Nrf2),
      Quantification of CoQ10 (Coenzyme Q10). 4) Biomarkers of oxidative stress. 5) miRNAs
      microarrays, RT-PCR validation and correlation/association studies. 6) Induction of
      over-expression of miRNAs of interest; luciferase constructs. 7)Studies of methylation.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in endothelial function in vivo
time frame: 0 weeks, 4 weeks, 8weeks, 12weeks
description: Study of the endothelial function in vivo. Variations in capilar blood flow of the skin will be analyzed by noninvasive Doppler laser fluorimetry using a Periflux 5000 equipment.
The study will be performed on 50 APS (antiphospholipid Syndrome) patients. Patients will be randomized to CoQ10 or placebo group. Treatments will be given for 1 month, according to a randomized and crossover design (with wash-out periods of four weeks) Blood will be drawn at time 0, at the end of treatment, and after three months of the end of treatment.
measure: Change in Tissue factor
time frame: 0 weeks, 4 weeks, 8 weeks, 12 weeks
description: Parameters related to inflammation and thrombosis in cells measure at mRNA and VEGF (Vascular Endothelial Growth Factor) in serum/plasma and cells.
The study will be performed on 50 APS (antiphospholipid Syndrome) patients. Patients will be randomized to CoQ10 or placebo group. Treatments will be given for 1 month, according to a randomized and crossover design (with wash-out periods of four weeks) Blood will be drawn at time 0, at the end of treatment, and after three months of the end of treatment.
arm group label: APS Patient
arm group type: Other
intervention type: Drug
intervention name: CoQ10
arm group label: APS Patient
intervention type: Drug
intervention name: Placebo
arm group label: APS Patient
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Rosario Lopez Pedrera, Biology
role: Principal Investigator
last name: Maria de los Angeles Aguirre, Medicine
phone: 0034639410897
email: maaguirrezamorano@yahoo.es
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Sponsor
mesh term: Thrombosis
mesh term: Coenzyme Q10