<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/NCT01709994</url>
  </required_header>
  <id_info>
    <org_study_id>MG001</org_study_id>
    <nct_id>NCT01709994</nct_id>
  </id_info>
  <brief_title>Primary Cardiovascular Risk Prevention With Aspirin in Chronic Kidney Disease Patients</brief_title>
  <official_title>Effect of Aspirin in Primary Prevention of Cardiovascular Risk in Patients With Chronic Kidney Disease (AASER Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to examine whether the use of low-dose aspirin (75-100 mg /&#xD;
      day) reduces the risk of cardiovascular disease in patients with chronic kidney disease&#xD;
      (stage 3 or 4).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothesis: The low-dose aspirin reduces cardiovascular risk in patients with chronic kidney&#xD;
      disease without increasing the risk of bleeding&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2010</start_date>
  <completion_date type="Anticipated">May 2015</completion_date>
  <primary_completion_date type="Anticipated">May 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiovascular events</measure>
    <time_frame>five years</time_frame>
    <description>To assess the benefit of treatment with low-dose aspirin in the primary prevention of cardiovascular events (incidence of the composite endpoint: death, acute coronary syndrome, stroke or nonfatal acute peripheral arteriopathy disease) in patients with chronic kidney disease who are not in dialysis or renal transplant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major bleeding</measure>
    <time_frame>five years</time_frame>
    <description>-Evaluate the incidence of major bleeding requiring hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>antiinflammatory effects of aspirin</measure>
    <time_frame>five years</time_frame>
    <description>-to analyze the antiinflammatory effect of aspirin in patients with chronic kidney disease</description>
  </secondary_outcome>
  <other_outcome>
    <measure>progression of chronic kidney disease</measure>
    <time_frame>five years</time_frame>
    <description>to Analyze the progression of CKD</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">97</enrollment>
  <condition>Chronic Kidney Disease Stage 4</condition>
  <condition>Chronic Kidney Disease Stage 3</condition>
  <arm_group>
    <arm_group_label>aspirin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Aspirin dosage 100 mg/day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>standard medication</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>the patients will continue with standard medication</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aspirin</intervention_name>
    <description>100 mg/day of aspirin</description>
    <arm_group_label>aspirin</arm_group_label>
    <other_name>ACETILSALYCILIC ACID</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  sign informed consent&#xD;
&#xD;
          -  males 45-79 years or females 55-79 years. -Stage 3 or 4 CKD (estimated GFR by MDRD&#xD;
             abbreviated, between 15 and 60 ml / min/1.73 m2) -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a previous cardiovascular event: cardiac arrhythmias, cardiac arrest, angina or acute&#xD;
             myocardial infarction, stroke, carotid stenosis of more than 50%, peripheral vascular&#xD;
             arteriopathy documented&#xD;
&#xD;
          -  hospitalization for any cause in the last three months prior to inclusion in the study&#xD;
             allergy of acetyl-salicylic acid&#xD;
&#xD;
          -  coagulopathy from any cause&#xD;
&#xD;
          -  thrombocytopenia &lt;150,000 platelets&#xD;
&#xD;
          -  liver disease from any cause&#xD;
&#xD;
          -  Infection by hepatitis B virus, hepatitis C or HIV&#xD;
&#xD;
          -  immunosuppressive treatment within 12 weeks before inclusion in the study&#xD;
&#xD;
          -  Major bleeding events including gastrointestinal bleeding and brain hemorrhage.&#xD;
&#xD;
          -  hemoglobinopathies (eg sickle cell disease or thalassemia of any kind)&#xD;
&#xD;
          -  active malignancy (except non-melanoma skin cancer). May be included in the study&#xD;
             patients with malignant neoplasia who have remained disease-free for at least the&#xD;
             previous 5 years.&#xD;
&#xD;
          -  uncontrolled inflammatory disease or symptomatic (eg rheumatoid arthritis, lupus,&#xD;
             Chrom disease or bowel inflammatory disease)&#xD;
&#xD;
          -  hemolysis&#xD;
&#xD;
          -  treatment with oral anticoagulation and / or antiplatelet therapy prior.&#xD;
&#xD;
          -  poorly controlled hypertension (&gt; 160/90 mm Hg) -pregnancy or breast-&#xD;
&#xD;
          -  women of childbearing potential not using effective contraception.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>JOSE LUÑO, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital General Universitario Gregorio Marañon</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>JOSE LUÑO, MD, PHD</last_name>
    <phone>0034915868319</phone>
    <email>jluno.hgugm@salud.madrid.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Marañon</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>MARIAN GOICOECHEA, MD, PhD</last_name>
      <phone>0034915868319</phone>
      <email>marian.goicoechea@gmail.com</email>
    </contact>
    <investigator>
      <last_name>MARIAN GOICOECHEA, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>October 17, 2012</last_update_submitted>
  <last_update_submitted_qc>October 17, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 18, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales</investigator_affiliation>
    <investigator_full_name>Jose Luño Fernandez</investigator_full_name>
    <investigator_title>Headmaster of Nephrology Department</investigator_title>
  </responsible_party>
  <keyword>cardiovascular events</keyword>
  <keyword>chronic kidney disease</keyword>
  <keyword>bleedings</keyword>
  <keyword>progression</keyword>
  <keyword>antiinflammatory effects</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <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/NCT01709994
org study id: MG001
nct id: NCT01709994
lead sponsor: 
has dmc: No
The objective of the study is to examine whether the use of low-dose aspirin (75-100 mg /
      day) reduces the risk of cardiovascular disease in patients with chronic kidney disease
      (stage 3 or 4).
Hypothesis: The low-dose aspirin reduces cardiovascular risk in patients with chronic kidney
      disease without increasing the risk of bleeding
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Cardiovascular events
time frame: five years
description: To assess the benefit of treatment with low-dose aspirin in the primary prevention of cardiovascular events (incidence of the composite endpoint: death, acute coronary syndrome, stroke or nonfatal acute peripheral arteriopathy disease) in patients with chronic kidney disease who are not in dialysis or renal transplant.
measure: Major bleeding
time frame: five years
description: -Evaluate the incidence of major bleeding requiring hospitalization
measure: antiinflammatory effects of aspirin
time frame: five years
description: -to analyze the antiinflammatory effect of aspirin in patients with chronic kidney disease
measure: progression of chronic kidney disease
time frame: five years
description: to Analyze the progression of CKD
arm group label: aspirin
arm group type: Active Comparator
description: Aspirin dosage 100 mg/day
arm group label: standard medication
arm group type: No Intervention
description: the patients will continue with standard medication
intervention type: Drug
intervention name: Aspirin
description: 100 mg/day of aspirin
arm group label: aspirin
other name: ACETILSALYCILIC ACID
criteria: 
gender: All
minimum age: 45 Years
maximum age: 79 Years
healthy volunteers: No
last name: JOSE LUÑO, MD, PhD
role: Principal Investigator
affiliation: Hospital General Universitario Gregorio Marañon
last name: JOSE LUÑO, MD, PHD
phone: 0034915868319
email: jluno.hgugm@salud.madrid.org
facility: 
status: Recruiting
contact: 
investigator: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales
investigator full name: Jose Luño Fernandez
investigator title: Headmaster of Nephrology Department
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Aspirin