<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/NCT02234427</url>
  </required_header>
  <id_info>
    <org_study_id>PARes-III</org_study_id>
    <nct_id>NCT02234427</nct_id>
  </id_info>
  <brief_title>Pharmacogenomics of Antiplatelet Response</brief_title>
  <acronym>PARes-III</acronym>
  <official_title>Pharmacogenomics of Antiplatelet Response</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial will examine with effect of 2-week aspirin therapy on platelet gene&#xD;
      expression in persons at high-risk of developing heart attacks due to family history of&#xD;
      early-onset coronary artery disease&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this clinical trials we will select individuals from GeneSTAR cohort based o their&#xD;
      platelet function. Equal number of individuals will be selected from each race and gender and&#xD;
      from low or high platelet aggregation. We will have baseline platelet functions performed and&#xD;
      baseline platelet gene expression examined. Participants will be given 2-week supply of&#xD;
      aspirin(81 mg/daily) and will be examined at the end of 2-weeks with platelet aggregation&#xD;
      studies and a repeat platelet gene-expression (using RNA-seq). The ultimate goal is to&#xD;
      examine platelet gene expression differences due to aspirin and across different gender,&#xD;
      race, platelet-aggregation groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Differential Gene Expression</measure>
    <time_frame>2-weeks</time_frame>
    <description>Differences in platelet transcriptome before and after 2-week aspirin therapy The expression levels of genes before aspirin therapy was compared with the expression level of the genes after aspirin therapy. The expression levels were measured using the FPKM unit (Fragments Per Kilobase of transcript per Million mapped reads). The gene with the highest difference (pre vs. post) in FPKM is being reported with name in the units area and the actual difference in the number area</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Atherosclerosis</condition>
  <arm_group>
    <arm_group_label>Aspirin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aspirin</intervention_name>
    <description>2-week aspirin therapy (81mg/day)</description>
    <arm_group_label>Aspirin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  45-75 years&#xD;
&#xD;
          -  GeneSTAR participant&#xD;
&#xD;
          -  No personal History of Coronary Artery Disease&#xD;
&#xD;
          -  Women who are post-menopausal&#xD;
&#xD;
          -  Women who are using a reliable method of contraception, such as history of tubal&#xD;
             ligation, IUD or taking OCP&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Taking aspirin prescribed by physician&#xD;
&#xD;
          -  weight &lt; 60 kg&#xD;
&#xD;
          -  History of recent or current bleeding&#xD;
&#xD;
          -  allergy to aspirin or history of adverse events to aspirin&#xD;
&#xD;
          -  serious comorbid conditions (such as AIDS, active cancer)&#xD;
&#xD;
          -  high blood pressure (&gt;160/95)&#xD;
&#xD;
          -  History of gastrointestinal ulcer/bleeding&#xD;
&#xD;
          -  Mental incompetence to make decision to participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rehan Qayyum, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins School of Medicine</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.genestarstudy.com</url>
    <description>GeneSTAR Research Program</description>
  </link>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <results_first_submitted>August 1, 2016</results_first_submitted>
  <results_first_submitted_qc>November 10, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 9, 2017</results_first_posted>
  <last_update_submitted>November 10, 2016</last_update_submitted>
  <last_update_submitted_qc>November 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johns Hopkins University</investigator_affiliation>
    <investigator_full_name>Rehan Qayyum</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>aspirin, atherosclerosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atherosclerosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Aspirin</title>
          <description>Aspirin: 2-week aspirin therapy (81mg/day)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="33">One individual withdrew after first visit</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Aspirin</title>
          <description>Aspirin: 2-week aspirin therapy (81mg/day)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="34"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.4" spread="10.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>African Americans</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caucasians</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Differential Gene Expression</title>
        <description>Differences in platelet transcriptome before and after 2-week aspirin therapy The expression levels of genes before aspirin therapy was compared with the expression level of the genes after aspirin therapy. The expression levels were measured using the FPKM unit (Fragments Per Kilobase of transcript per Million mapped reads). The gene with the highest difference (pre vs. post) in FPKM is being reported with name in the units area and the actual difference in the number area</description>
        <time_frame>2-weeks</time_frame>
        <population>The data were analyzed combining results from two studies (24 from this study and additional 33 individuals from study NCT01894555; total population size = 57) to improve the power to detect a difference. Same results are reported for the two studies. Note that the top most gene (HBG1) with the lowest p-value is being reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Aspirin</title>
            <description>Aspirin: 2-week aspirin therapy (81mg/day)</description>
          </group>
        </group_list>
        <measure>
          <title>Differential Gene Expression</title>
          <description>Differences in platelet transcriptome before and after 2-week aspirin therapy The expression levels of genes before aspirin therapy was compared with the expression level of the genes after aspirin therapy. The expression levels were measured using the FPKM unit (Fragments Per Kilobase of transcript per Million mapped reads). The gene with the highest difference (pre vs. post) in FPKM is being reported with name in the units area and the actual difference in the number area</description>
          <population>The data were analyzed combining results from two studies (24 from this study and additional 33 individuals from study NCT01894555; total population size = 57) to improve the power to detect a difference. Same results are reported for the two studies. Note that the top most gene (HBG1) with the lowest p-value is being reported.</population>
          <units>FPKM for HBG1 Gene</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.1" spread="19.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Null Hypothesis: There is no difference in gene expression before and after aspirin therapy</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.000005</p_value>
            <p_value_desc>Above noted p-value is adjusted for multiple comparisons. Analysis was performed using the TopHat/Cufflinks pipeline. The differential expression algorithm uses a beta distribution and the overdispersion with a negative binomial distribution.</p_value_desc>
            <method>negative binomial</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Aspirin</title>
          <description>Aspirin: 2-week aspirin therapy (81mg/day)</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Rehan Qayyum</name_or_title>
      <organization>Johns Hopkins School of Medicine</organization>
      <phone>410-955-7781</phone>
      <email>rqayyum@jhmi.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02234427
org study id: PARes-III
nct id: NCT02234427
lead sponsor: 
has dmc: Yes
This clinical trial will examine with effect of 2-week aspirin therapy on platelet gene
      expression in persons at high-risk of developing heart attacks due to family history of
      early-onset coronary artery disease
In this clinical trials we will select individuals from GeneSTAR cohort based o their
      platelet function. Equal number of individuals will be selected from each race and gender and
      from low or high platelet aggregation. We will have baseline platelet functions performed and
      baseline platelet gene expression examined. Participants will be given 2-week supply of
      aspirin(81 mg/daily) and will be examined at the end of 2-weeks with platelet aggregation
      studies and a repeat platelet gene-expression (using RNA-seq). The ultimate goal is to
      examine platelet gene expression differences due to aspirin and across different gender,
      race, platelet-aggregation groups.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Differential Gene Expression
time frame: 2-weeks
description: Differences in platelet transcriptome before and after 2-week aspirin therapy The expression levels of genes before aspirin therapy was compared with the expression level of the genes after aspirin therapy. The expression levels were measured using the FPKM unit (Fragments Per Kilobase of transcript per Million mapped reads). The gene with the highest difference (pre vs. post) in FPKM is being reported with name in the units area and the actual difference in the number area
arm group label: Aspirin
arm group type: Experimental
intervention type: Drug
intervention name: Aspirin
description: 2-week aspirin therapy (81mg/day)
arm group label: Aspirin
criteria: 
gender: All
minimum age: 45 Years
maximum age: 75 Years
healthy volunteers: No
last name: Rehan Qayyum, MD
role: Principal Investigator
affiliation: Johns Hopkins School of Medicine
facility: 
country: United States
url: http://www.genestarstudy.com
description: GeneSTAR Research Program
responsible party type: Principal Investigator
investigator affiliation: Johns Hopkins University
investigator full name: Rehan Qayyum
investigator title: Assistant Professor
mesh term: Atherosclerosis
mesh term: Aspirin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 