<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/NCT02214654</url>
  </required_header>
  <id_info>
    <org_study_id>ISSBRIL0241</org_study_id>
    <nct_id>NCT02214654</nct_id>
  </id_info>
  <brief_title>A Pilot Study To Examine The Effects Of Ticagrelor To Protect Against Type 2 Diabetes-Induced Vascular Damage</brief_title>
  <official_title>A Pilot Study To Examine The Effects Of Ticagrelor To Protect Against Type 2 Diabetes-Induced Vascular Damage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Tianjin Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare clopidogrel with ticagrelor which one has stronger&#xD;
      anti-inflammation effect to protect against type 2 diabetes-induced vascular damage.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      i- Verify the study inclusion and exclusion criteria at visit 1.&#xD;
&#xD;
      ii- Inform patients (verbally and in writing) and their caregivers (when considered necessary&#xD;
      and with the patient's consent) of the characteristics of the study and confirm their&#xD;
      agreement to participate by signing the informed consent document.&#xD;
&#xD;
      iii- Assist with patient assessment, record the information in the case report form. Based on&#xD;
      the data we get from the case report form, assign the patient to the experimental or control&#xD;
      group by stratified randomization.&#xD;
&#xD;
      ⅳ- At visit 2 to obtain blood sample from peripheral vessel and analyze the density of&#xD;
      CECs,sCD40L and hs-CRP by flow cytometry (FCM), ELISA and particle-enhanced turbidimetric&#xD;
      immunoassay.&#xD;
&#xD;
      ⅴ- All patients are given aspirin 100mg/qd orally and the experimental group given ticagrelor&#xD;
      90mg/bid while the control group clopidogrel 75mg/qd for 30 days.&#xD;
&#xD;
      ⅵ- At visit 3 repeating step ⅳ and making comparison on numbers of CECs and CD40L between the&#xD;
      two groups, and finish a statistic analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">June 2015</completion_date>
  <primary_completion_date type="Anticipated">March 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Month</target_duration>
  <primary_outcome>
    <measure>circulation endothelial cell</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">144</enrollment>
  <condition>Type 2 Diabetes Mellitus；</condition>
  <condition>Stable Coronary Disease</condition>
  <arm_group>
    <arm_group_label>ticagrelor，clopidogrel，antiplatelet drugs</arm_group_label>
  </arm_group>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      We will collect blood samples from the vena mediana cubiti, volume of sample blood will be&#xD;
      5ml.Centrifuge samples at 700gfor 20 min at 4 °C with no brake.Remove gently the upper phase&#xD;
      (plasma) with a 5 ml pipette into a separate tube and store in 0.25 ml aliquots.Distribute&#xD;
      500 μl of samples into one isotype control and three sample tubes and add the special&#xD;
      antibodies.Then account the CECs and sCD40/40L,etc.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All patients will be enrolled from outpatient and in hospital in Tianjin First Central&#xD;
        Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provision of informed consent prior to any study specific procedures.&#xD;
&#xD;
          2. A previous or new diagnosis of type 2 diabetes mellitus, document by one of following&#xD;
             criteria:1）Hemoglobin A1c of ≥6.5% at diagnosis;2) Fasting plasma glucose (FPG)&#xD;
             ≥126mg/dL (7.0 mmol/L);3) Two-hour plasma glucose≥200 mg/dL (11.1 mmol/L) during an&#xD;
             oral glucose tolerance test (OGTT);4) with classic symptoms of hyperglycemia or&#xD;
             hyperglycemic crisis, a random plasma glucose≥200mg/dL (11.1 mmol/L)( confirmed by&#xD;
             repeat testing)&#xD;
&#xD;
          3. A previous or new diagnosis of stable CAD according to ICD 10 for at least 6 months,&#xD;
             document by following criteria: 1) Stable angina; 2) No AMI or NSTE-ACS within 1&#xD;
             month;and(or) 3) EKG with ischemic ST-segment and(or) T-wave change; and(or)4)&#xD;
             coronory artery stenosis ≥50% viewed by coronary CTA or coronary angiography&#xD;
&#xD;
          4. No medication history of clopidogrel/ticagrelor for at least 1 months&#xD;
&#xD;
          5. Female or male, and any race, aged≥18 years, not pregnant.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Blood pressure&gt;160/100 mm Hg;&#xD;
&#xD;
          2. Hypercholesterolemia(LDL-c &gt;240mg/dl);&#xD;
&#xD;
          3. Hemoglobin A1c ≥ 10%;&#xD;
&#xD;
          4. Platelet count less than 10*10^9/L or hemoglobin &lt;10 g/dL;&#xD;
&#xD;
          5. Intolerance or allergy to clopidogrel/ticagrelor or any of the excipients;&#xD;
&#xD;
          6. Patient with known inflammatory conditions or those on anti-inflammatory drug therapy;&#xD;
&#xD;
          7. Second and third degree atrioventricular block;&#xD;
&#xD;
          8. chronic obstructive lung disease or asthma;&#xD;
&#xD;
          9. Creatinine&gt;2 mg/dl;&#xD;
&#xD;
         10. Malignancy;&#xD;
&#xD;
         11. Moderate or severe hepatic impairment;&#xD;
&#xD;
         12. History of intracranial haemorrhage;&#xD;
&#xD;
         13. Active pathological bleeding;&#xD;
&#xD;
         14. Pregnancy or lactation;&#xD;
&#xD;
         15. Any condition that increases the risk for noncompliance or being lost to follow-up;&#xD;
&#xD;
         16. Medicine history of potent CYP3A4 inhibitor(ketoconazole, clarithromycin,etc.);&#xD;
&#xD;
         17. No provision of informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaofei Wang, doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tianjin First Central Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tianjin First Central Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300192</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin First Central Hospital</name>
      <address>
        <city>Tianjin</city>
        <zip>300192</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Xiaofei Wang, doctor</last_name>
      <email>wangxiaofei@medmail.com.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>August 10, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>August 11, 2014</last_update_submitted>
  <last_update_submitted_qc>August 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tianjin First Central Hospital</investigator_affiliation>
    <investigator_full_name>Xiaofei Wang</investigator_full_name>
    <investigator_title>Tianjin International Medical Center</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_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/NCT02214654
org study id: ISSBRIL0241
nct id: NCT02214654
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to compare clopidogrel with ticagrelor which one has stronger
      anti-inflammation effect to protect against type 2 diabetes-induced vascular damage.
i- Verify the study inclusion and exclusion criteria at visit 1.

      ii- Inform patients (verbally and in writing) and their caregivers (when considered necessary
      and with the patient's consent) of the characteristics of the study and confirm their
      agreement to participate by signing the informed consent document.

      iii- Assist with patient assessment, record the information in the case report form. Based on
      the data we get from the case report form, assign the patient to the experimental or control
      group by stratified randomization.

      ⅳ- At visit 2 to obtain blood sample from peripheral vessel and analyze the density of
      CECs,sCD40L and hs-CRP by flow cytometry (FCM), ELISA and particle-enhanced turbidimetric
      immunoassay.

      ⅴ- All patients are given aspirin 100mg/qd orally and the experimental group given ticagrelor
      90mg/bid while the control group clopidogrel 75mg/qd for 30 days.

      ⅵ- At visit 3 repeating step ⅳ and making comparison on numbers of CECs and CD40L between the
      two groups, and finish a statistic analysis.
observational model: Case-Control
time perspective: Prospective
measure: circulation endothelial cell
time frame: 1 month
arm group label: ticagrelor，clopidogrel，antiplatelet drugs
We will collect blood samples from the vena mediana cubiti, volume of sample blood will be
      5ml.Centrifuge samples at 700gfor 20 min at 4 °C with no brake.Remove gently the upper phase
      (plasma) with a 5 ml pipette into a separate tube and store in 0.25 ml aliquots.Distribute
      500 μl of samples into one isotype control and three sample tubes and add the special
      antibodies.Then account the CECs and sCD40/40L,etc.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Xiaofei Wang, doctor
role: Principal Investigator
affiliation: Tianjin First Central Hospital
facility: 
facility: 
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Tianjin First Central Hospital
investigator full name: Xiaofei Wang
investigator title: Tianjin International Medical Center
mesh term: Coronary Disease
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2