<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/NCT03289520</url>
  </required_header>
  <id_info>
    <org_study_id>DAC Fistual</org_study_id>
    <secondary_id>U01DK058982</secondary_id>
    <nct_id>NCT03289520</nct_id>
  </id_info>
  <brief_title>Clopidogrel Prevention of Early Arteriovenous (AV) Fistula Thrombosis</brief_title>
  <acronym>FISTULA</acronym>
  <official_title>Effect of Clopidogrel on Early Failure of Arteriovenous Fistulas for Hemodialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Iowa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>MaineHealth</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Baystate Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vanderbilt University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CAMC Health System</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>St. Louis University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tyler Nephrology Associates</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vascular Surgery Associates LLC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to determine whether clopidogrel reduces the early failure rate&#xD;
      of native AV fistulae. This study was originally registered as NCT00067119 which included two&#xD;
      protocols, this one and the GRAFT study)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2003</start_date>
  <completion_date type="Actual">June 18, 2007</completion_date>
  <primary_completion_date type="Actual">June 18, 2007</primary_completion_date>
  <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fistula thrombosis (patency failure)</measure>
    <time_frame>6 weeks</time_frame>
    <description>The fistula was classified as patent if a bruit was audible with a stethoscope throughout systole and diastole at least 8 cm proximal to the arteriovenous anastomosis. Fistula patency was assessed by trained study personnel.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Failure to attain suitability for dialysis (ability to use the fistula for dialysis with 2 needles and maintain a dialysis machine blood flow rate adequate for optimal dialysis (&gt;=300 mL/min))</measure>
    <time_frame>30 days</time_frame>
    <description>Fistula suitability was defined as the ability to use the fistula for dialysis with 2 needles and maintain a dialysis machine blood flow rate adequate for optimal dialysis (&gt;=300 mL/min) during 8 of 12 dialysis sessions occurring during a 30-day suitability ascertainment period. For participants receiving maintenance hemodialysis at the time of enrollment and for participants who started maintenance hemodialysis within 120 days after fistula creation, the suitability ascertainment period began between 120 and 150 days after fistula creation surgery.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">877</enrollment>
  <condition>Kidney Failure</condition>
  <condition>Hemodialysis Fistula Thrombosis</condition>
  <arm_group>
    <arm_group_label>Clopidogrel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clopidogrel</intervention_name>
    <arm_group_label>Clopidogrel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Fistula Study Protocol&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-21 depending on state regulations&#xD;
&#xD;
          -  Life expectancy of at least six months&#xD;
&#xD;
          -  Chronic renal failure with anticipated start of hemodialysis within six months of&#xD;
             enrollment, or current dialysis dependence&#xD;
&#xD;
          -  Planned creation of native upper extremity AV fistula&#xD;
&#xD;
          -  The patient is not on aspirin, or the patient is on aspirin but has not had a&#xD;
             myocardial infarction or a cerebrovascular accident within the past 12 months.&#xD;
&#xD;
          -  The patient is expected to stay at a participating dialysis facility for at least 6&#xD;
             months.&#xD;
&#xD;
          -  The patient's physician(s) will allow the patient to participate.&#xD;
&#xD;
          -  Ability to give informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women must not be pregnant, breastfeeding, or plan to be pregnant during the course of&#xD;
             the study.&#xD;
&#xD;
          -  The presence of ongoing bleeding.&#xD;
&#xD;
          -  The presence of a known bleeding disorder (e.g., hemophilia or von Willebrand's&#xD;
             disease).&#xD;
&#xD;
          -  Recent bleeding episode requiring transfusion within 12 weeks of entry.&#xD;
&#xD;
          -  The presence of acute ulcer disease. Acute ulcer disease is defined as a new diagnosis&#xD;
             of peptic disease including esophagitis, gastritis, or ulcer or the initiation of&#xD;
             treatment with proton pump inhibitors, H2 blockers or therapy for Helicobacter pylori&#xD;
             within three months prior to obtaining consent.&#xD;
&#xD;
          -  A condition which prohibits discontinuation of anticoagulant drugs, aspirin, or&#xD;
             nonsteroidal anti-inflammatory drugs during the six week study drug administration&#xD;
             period. Use of heparin during dialysis is allowed.&#xD;
&#xD;
          -  Required use of oral or intravenous glucocorticoids at a dose greater than the&#xD;
             equivalent of prednisone 15 mg per day during the six week study drug administration&#xD;
             period.&#xD;
&#xD;
          -  Current unstable angina.&#xD;
&#xD;
          -  Required use of clopidogrel.&#xD;
&#xD;
          -  Known hypersensitivity to clopidogrel.&#xD;
&#xD;
          -  Medical considerations making anti-platelet therapy dangerous.&#xD;
&#xD;
          -  Current uncontrolled hypertension with systolic blood pressure in excess of 200 mm Hg&#xD;
             or diastolic blood pressure in excess of 115 mm Hg at the time of enrollment.&#xD;
&#xD;
          -  Baseline platelet count less than 75,000/mm3.&#xD;
&#xD;
          -  Known advanced liver disease with decompensated cirrhosis, jaundice, ascites or&#xD;
             bleeding varices.&#xD;
&#xD;
          -  Current problem with substance abuse.&#xD;
&#xD;
          -  Concurrent participation in another medical intervention trial.&#xD;
&#xD;
          -  Anticipated non-compliance with medical care based on physician judgment.&#xD;
&#xD;
          -  Patient refusal.&#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_official>
    <last_name>John W Kusek, Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>NIDDK - Telephone: 301-594-7717; Email: kusekj@ep.niddk.nih.gov</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Catherine Meyers, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>NIDDK - Telephone: 301-451-4901; Email: meyersc@extra.niddk.nih.gov</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maine Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Maine</state>
        <zip>04102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston University Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest University</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Dember LM, Kaufman JS, Beck GJ, Dixon BS, Gassman JJ, Greene T, Himmelfarb J, Hunsicker LG, Kusek JW, Lawson JH, Middleton JP, Radeva M, Schwab SJ, Whiting JF, Feldman HI; DAC Study Group. Design of the Dialysis Access Consortium (DAC) Clopidogrel Prevention of Early AV Fistula Thrombosis Trial. Clin Trials. 2005;2(5):413-22. doi: 10.1191/1740774505cn118oa.</citation>
    <PMID>16317810</PMID>
  </reference>
  <results_reference>
    <citation>Dember LM, Beck GJ, Allon M, Delmez JA, Dixon BS, Greenberg A, Himmelfarb J, Vazquez MA, Gassman JJ, Greene T, Radeva MK, Braden GL, Ikizler TA, Rocco MV, Davidson IJ, Kaufman JS, Meyers CM, Kusek JW, Feldman HI; Dialysis Access Consortium Study Group. Effect of clopidogrel on early failure of arteriovenous fistulas for hemodialysis: a randomized controlled trial. JAMA. 2008 May 14;299(18):2164-71. doi: 10.1001/jama.299.18.2164.</citation>
    <PMID>18477783</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>September 19, 2017</last_update_submitted>
  <last_update_submitted_qc>September 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Access Blood Flow Monitoring</keyword>
  <keyword>Clinical Trial Vascular Access</keyword>
  <keyword>Fistula Failure</keyword>
  <keyword>Hemodialysis</keyword>
  <keyword>Vascular Access</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Fistula</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clopidogrel</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be available at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>September 2011</ipd_time_frame>
    <ipd_url>https://www.niddkrepository.org/studies/fistula/?query=dac</ipd_url>
  </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/NCT03289520
org study id: DAC Fistual
secondary id: U01DK058982
nct id: NCT03289520
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
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collaborator: 
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collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The objective of the study is to determine whether clopidogrel reduces the early failure rate
      of native AV fistulae. This study was originally registered as NCT00067119 which included two
      protocols, this one and the GRAFT study)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Fistula thrombosis (patency failure)
time frame: 6 weeks
description: The fistula was classified as patent if a bruit was audible with a stethoscope throughout systole and diastole at least 8 cm proximal to the arteriovenous anastomosis. Fistula patency was assessed by trained study personnel.
measure: Failure to attain suitability for dialysis (ability to use the fistula for dialysis with 2 needles and maintain a dialysis machine blood flow rate adequate for optimal dialysis (>=300 mL/min))
time frame: 30 days
description: Fistula suitability was defined as the ability to use the fistula for dialysis with 2 needles and maintain a dialysis machine blood flow rate adequate for optimal dialysis (>=300 mL/min) during 8 of 12 dialysis sessions occurring during a 30-day suitability ascertainment period. For participants receiving maintenance hemodialysis at the time of enrollment and for participants who started maintenance hemodialysis within 120 days after fistula creation, the suitability ascertainment period began between 120 and 150 days after fistula creation surgery.
arm group label: Clopidogrel
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Clopidogrel
arm group label: Clopidogrel
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John W Kusek, Ph.D.
role: Study Director
affiliation: NIDDK - Telephone: 301-594-7717; Email: kusekj@ep.niddk.nih.gov
last name: Catherine Meyers, M.D.
role: Study Director
affiliation: NIDDK - Telephone: 301-451-4901; Email: meyersc@extra.niddk.nih.gov
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Dember LM, Kaufman JS, Beck GJ, Dixon BS, Gassman JJ, Greene T, Himmelfarb J, Hunsicker LG, Kusek JW, Lawson JH, Middleton JP, Radeva M, Schwab SJ, Whiting JF, Feldman HI; DAC Study Group. Design of the Dialysis Access Consortium (DAC) Clopidogrel Prevention of Early AV Fistula Thrombosis Trial. Clin Trials. 2005;2(5):413-22. doi: 10.1191/1740774505cn118oa.
PMID: 16317810
citation: Dember LM, Beck GJ, Allon M, Delmez JA, Dixon BS, Greenberg A, Himmelfarb J, Vazquez MA, Gassman JJ, Greene T, Radeva MK, Braden GL, Ikizler TA, Rocco MV, Davidson IJ, Kaufman JS, Meyers CM, Kusek JW, Feldman HI; Dialysis Access Consortium Study Group. Effect of clopidogrel on early failure of arteriovenous fistulas for hemodialysis: a randomized controlled trial. JAMA. 2008 May 14;299(18):2164-71. doi: 10.1001/jama.299.18.2164.
PMID: 18477783
responsible party type: Sponsor
mesh term: Renal Insufficiency
mesh term: Thrombosis
mesh term: Fistula
mesh term: Clopidogrel
sharing ipd: Yes
ipd description: Data will be available at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: September 2011
ipd url: https://www.niddkrepository.org/studies/fistula/?query=dac