<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/NCT02261025</url>
  </required_header>
  <id_info>
    <org_study_id>20120308</org_study_id>
    <nct_id>NCT02261025</nct_id>
  </id_info>
  <brief_title>The Effect Of Aspirin On Survival in in Patients Undergoing Chronic Hemodialysis</brief_title>
  <official_title>The Effect Of Aspirin On Survival in in Patients Undergoing Chronic Hemodialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Jiao Tong University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of present study is to examine the effect of low-dose aspirin on the incidence of&#xD;
      cardiovascular events and mortality in patients undergoing chronic hemodialysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study prospectively evaluate the impacts of low dose aspirin on survival and&#xD;
      cardio-cerebral vascular events in a large cohort of Chinese patients undergoing chronic&#xD;
      hemodialysis. Between January 2008, consecutive patients with hemodialysis with aspirin were&#xD;
      enrolled.We examine the association of aspirin with all-cause mortality in patients matched&#xD;
      by propensity scores using the Kaplan-Meier method and Cox models in &quot;intention-to-treat&quot;&#xD;
      analyses.The secondary endpoint was rate of cardio-cerebral events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2008</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>survival rate</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>cardio-cerebral event</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">410</enrollment>
  <condition>Hemodialysis</condition>
  <arm_group>
    <arm_group_label>Aspirin group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aspirin 75-100mg,per day，oral</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-aspirin group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No interventions</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>acetylsalicylic acid</intervention_name>
    <description>75-100mg,per day</description>
    <arm_group_label>Aspirin group</arm_group_label>
    <other_name>Aspirin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All patients aged 18 to 85, undergoing chronic hemodialysis, who have none of the following&#xD;
        exclusion criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        History of gastric or duodenal ulcers Known allergy to aspirin or other NSAIDs&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>October 22, 2014</last_update_submitted>
  <last_update_submitted_qc>October 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 23, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Jiao Tong University School of Medicine</investigator_affiliation>
    <investigator_full_name>Hui Min Jin</investigator_full_name>
    <investigator_title>Shanghai Jiao Tong University School of Medicine</investigator_title>
  </responsible_party>
  <keyword>aspirin</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</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/NCT02261025
org study id: 20120308
nct id: NCT02261025
lead sponsor: 
has dmc: Yes
The aim of present study is to examine the effect of low-dose aspirin on the incidence of
      cardiovascular events and mortality in patients undergoing chronic hemodialysis.
This study prospectively evaluate the impacts of low dose aspirin on survival and
      cardio-cerebral vascular events in a large cohort of Chinese patients undergoing chronic
      hemodialysis. Between January 2008, consecutive patients with hemodialysis with aspirin were
      enrolled.We examine the association of aspirin with all-cause mortality in patients matched
      by propensity scores using the Kaplan-Meier method and Cox models in "intention-to-treat"
      analyses.The secondary endpoint was rate of cardio-cerebral events.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: survival rate
time frame: 5 years
measure: cardio-cerebral event
time frame: 5 years
arm group label: Aspirin group
arm group type: Experimental
description: Aspirin 75-100mg,per day，oral
arm group label: non-aspirin group
arm group type: No Intervention
description: No interventions
intervention type: Drug
intervention name: acetylsalicylic acid
description: 75-100mg,per day
arm group label: Aspirin group
other name: Aspirin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Shanghai Jiao Tong University School of Medicine
investigator full name: Hui Min Jin
investigator title: Shanghai Jiao Tong University School of Medicine
mesh term: Aspirin