<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/NCT02972385</url>
  </required_header>
  <id_info>
    <org_study_id>1608762767</org_study_id>
    <nct_id>NCT02972385</nct_id>
  </id_info>
  <brief_title>Pharmacogenomics of Warfarin in Hispanics and Latinos</brief_title>
  <official_title>Pharmacogenomics of Warfarin in Hispanics and Latinos</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arizona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Arizona</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Warfarin is a commonly used blood thinner to treat and prevent blood clots. It is important&#xD;
      to take the right dose of warfarin because too much can increase the risk of bleeding and too&#xD;
      little can increase the risk of blood clots. This is why patients are closely monitored&#xD;
      especially when they begin warfarin therapy. When clinicians prescribe warfarin, they have to&#xD;
      consider different factors such as patient's age, body size, diet, and other medications that&#xD;
      can interact with warfarin.&#xD;
&#xD;
      Certain genes have also been found to affect warfarin dose. Individuals have variations in&#xD;
      these genes, which can help explain why some patients need higher dose and others require&#xD;
      less. These factors have been used to better predict a patient's warfarin dose requirement.&#xD;
      However, these predictions were created based on Caucasian populations and they may not be&#xD;
      accurate in predicting a safe warfarin dose if a patient is not Caucasian. This study aims to&#xD;
      identify new genetic variation that affects warfarin dosing in Hispanic and Latino&#xD;
      populations and try to better predict a Hispanic or Latino patient's warfarin dose&#xD;
      requirement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      If the patient is willing to hear about the study, during routine clinical care, one of the&#xD;
      patient's providers will approach patients meeting the study criteria about participation in&#xD;
      the study. Study personnel will not approach potential participants unless permission is&#xD;
      given to the patient's provider. If the patient would like to participate in the study, study&#xD;
      personnel will discuss details of the study in person during the patient's routine clinical&#xD;
      care visit. There will also be a flyers available for posting and for distribution to&#xD;
      potential participants.&#xD;
&#xD;
      Participants consenting to the study will be asked to provide a cheek swab or mouthwash&#xD;
      sample to provide buccal cells for DNA extraction. If the patient is receiving a blood draw&#xD;
      during their regular clinical appointment, participants will be asked for a blood sample of&#xD;
      15 milliliters. Genomic DNA will be isolated for genotyping and patient plasma samples will&#xD;
      also be stored.&#xD;
&#xD;
      Linear regression will be used to test association of SNPs with therapeutic warfarin dose&#xD;
      using the algorithms derived by the International Warfarin Pharmacogenomics Consortium. The&#xD;
      primary phenotype (weekly stable warfarin dose) will be transformed by square root. SNPs and&#xD;
      other variables associated with warfarin dose will be assessed in univariate analyses and&#xD;
      entered into stepwise linear regression to determine the adjusted association with dose&#xD;
      requirements using R2. Quality control procedures will include deviation from Hardy-Weinberg&#xD;
      Equilibrium, and SNP and sample exclusions based on call rates. Ancestry-informative marker&#xD;
      (AIM) analysis will be performed to estimate ancestry in each individual.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Anticipated">September 2022</completion_date>
  <primary_completion_date type="Anticipated">September 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Stable warfarin dose</measure>
    <time_frame>At time of enrollment</time_frame>
    <description>Dose of warfarin required to maintain stable INR for at least 2 consecutive clinic visits.</description>
  </primary_outcome>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Thrombosis</condition>
  <condition>Hemorrhage</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mouthwash sample</intervention_name>
    <description>A one time mouthwash sample will be performed.</description>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood Draw</intervention_name>
    <description>Patients who are receiving a blood draw during their regular clinical appointment will be asked for a blood sample of 15 milliliters. Genomic DNA will be isolated for genotyping and patient plasma samples will also be stored.</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Retention: Samples with DNA Description: Isolated DNA will be stored in freezers at minus 80&#xD;
      degrees.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will be Hispanic and Latino patients on stable doses of warfarin&#xD;
        therapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
          -  Ability to give informed consent&#xD;
&#xD;
          -  Therapeutic INR for at least 2 consecutive clinic visits&#xD;
&#xD;
          -  Self-identifies as Hispanic or Latino&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 18 years old&#xD;
&#xD;
          -  Unable to give informed consent&#xD;
&#xD;
          -  Severe hepatic impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jason H Karnes, PharmD, PhD</last_name>
    <phone>520-626-1447</phone>
    <email>karnes@pharmacy.arizona.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Heidi E Steiner, BS</last_name>
    <phone>520-626-3326</phone>
    <email>steiner@pharmacy.arizona.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Banner University Medical Center - Tucson</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85721</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jason H Karnes, PharmD, PhD</last_name>
      <phone>520-626-1447</phone>
      <email>karnes@pharmacy.arizona.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>April 26, 2021</last_update_submitted>
  <last_update_submitted_qc>April 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Arizona</investigator_affiliation>
    <investigator_full_name>Jason H Karnes</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>warfarin</keyword>
  <keyword>blood clotting</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_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/NCT02972385
org study id: 1608762767
nct id: NCT02972385
lead sponsor: 
has dmc: No
Warfarin is a commonly used blood thinner to treat and prevent blood clots. It is important
      to take the right dose of warfarin because too much can increase the risk of bleeding and too
      little can increase the risk of blood clots. This is why patients are closely monitored
      especially when they begin warfarin therapy. When clinicians prescribe warfarin, they have to
      consider different factors such as patient's age, body size, diet, and other medications that
      can interact with warfarin.

      Certain genes have also been found to affect warfarin dose. Individuals have variations in
      these genes, which can help explain why some patients need higher dose and others require
      less. These factors have been used to better predict a patient's warfarin dose requirement.
      However, these predictions were created based on Caucasian populations and they may not be
      accurate in predicting a safe warfarin dose if a patient is not Caucasian. This study aims to
      identify new genetic variation that affects warfarin dosing in Hispanic and Latino
      populations and try to better predict a Hispanic or Latino patient's warfarin dose
      requirement.
If the patient is willing to hear about the study, during routine clinical care, one of the
      patient's providers will approach patients meeting the study criteria about participation in
      the study. Study personnel will not approach potential participants unless permission is
      given to the patient's provider. If the patient would like to participate in the study, study
      personnel will discuss details of the study in person during the patient's routine clinical
      care visit. There will also be a flyers available for posting and for distribution to
      potential participants.

      Participants consenting to the study will be asked to provide a cheek swab or mouthwash
      sample to provide buccal cells for DNA extraction. If the patient is receiving a blood draw
      during their regular clinical appointment, participants will be asked for a blood sample of
      15 milliliters. Genomic DNA will be isolated for genotyping and patient plasma samples will
      also be stored.

      Linear regression will be used to test association of SNPs with therapeutic warfarin dose
      using the algorithms derived by the International Warfarin Pharmacogenomics Consortium. The
      primary phenotype (weekly stable warfarin dose) will be transformed by square root. SNPs and
      other variables associated with warfarin dose will be assessed in univariate analyses and
      entered into stepwise linear regression to determine the adjusted association with dose
      requirements using R2. Quality control procedures will include deviation from Hardy-Weinberg
      Equilibrium, and SNP and sample exclusions based on call rates. Ancestry-informative marker
      (AIM) analysis will be performed to estimate ancestry in each individual.
observational model: Cohort
time perspective: Prospective
measure: Stable warfarin dose
time frame: At time of enrollment
description: Dose of warfarin required to maintain stable INR for at least 2 consecutive clinic visits.
intervention type: Procedure
intervention name: Mouthwash sample
description: A one time mouthwash sample will be performed.
intervention type: Procedure
intervention name: Blood Draw
description: Patients who are receiving a blood draw during their regular clinical appointment will be asked for a blood sample of 15 milliliters. Genomic DNA will be isolated for genotyping and patient plasma samples will also be stored.
Retention: Samples with DNA Description: Isolated DNA will be stored in freezers at minus 80
      degrees.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jason H Karnes, PharmD, PhD
phone: 520-626-1447
email: karnes@pharmacy.arizona.edu
last name: Heidi E Steiner, BS
phone: 520-626-3326
email: steiner@pharmacy.arizona.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Arizona
investigator full name: Jason H Karnes
investigator title: Assistant Professor
mesh term: Thrombosis
mesh term: Hemorrhage
sharing ipd: No