<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/NCT02198053</url>
  </required_header>
  <id_info>
    <org_study_id>azliquan</org_study_id>
    <nct_id>NCT02198053</nct_id>
  </id_info>
  <brief_title>the Effect Between Platelet Reactivation and Antiplatelet Drugs</brief_title>
  <official_title>Effect of 180 mgTicagrelor Compared With 90 mg Ticagrelor on Platelet Reactivity in Patients Undergoing Elective PCI.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Anzhen Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Anzhen Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Different antiplatelet drugs played various role in coronary artery disease. The mechanisms&#xD;
      were unclear. Platelet reactivation maybe was one of major causes. Compared with clopidogrel,&#xD;
      Ticagrelor is more powerful antiplatelet drug. However, because of increased bleeding and&#xD;
      dyspnea risk, both loading double dose and following second dose time had potential risk and&#xD;
      inconvenient in routine clinical work, especially in elective PCI of comparable stable&#xD;
      patients in Chinese. The benefit and risk should be balanced in such patients. The&#xD;
      investigators supposed loading single dose and followed by second routine time dose was&#xD;
      superior to clopidogrel and safer than ticagrelor previously prescribed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All admission patients were divided into two groups, the first group were prescribed loading&#xD;
      dose (180 mg) ticagrelor, the second group were prescribed with 90 mg ticagrelor. We measured&#xD;
      both platelet activity and platelet reactivity using the LTA at baseline, pre-operation and&#xD;
      post-operation. All bleeding or dyspnea events were recorded in hospital period.&#xD;
&#xD;
      Primary endpoints: platelet activity, platelet reactivity using the LTA and safety events&#xD;
      were recorded in hospital period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>May 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">December 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 Year</target_duration>
  <primary_outcome>
    <measure>Platelet reactivity</measure>
    <time_frame>1 year</time_frame>
    <description>LTA and TEG used to measure the effect of Platelet reactivity</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">74</enrollment>
  <condition>Drug Effect Disorder</condition>
  <condition>Platelet Procoagulant Activity Deficiency</condition>
  <arm_group>
    <arm_group_label>Ticagrelor2</arm_group_label>
    <description>Ticagrelor with a loading dose of 180mg followed by 90 mg twice per day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ticagrelor1</arm_group_label>
    <description>Ticagrelor with a dose of 90mg followed by 90 mg twice per day .</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Platelet reactivity&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Chinese&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        coronary artery disease, percutaneous coronary intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        high risk bleeding patient, allergic to the drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>LI QUAN, doctor</last_name>
    <role>Study Director</role>
    <affiliation>Beijing Anzhen Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anzhen Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>July 20, 2015</last_update_submitted>
  <last_update_submitted_qc>July 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Anzhen Hospital</investigator_affiliation>
    <investigator_full_name>quan li</investigator_full_name>
    <investigator_title>associate chief physician</investigator_title>
  </responsible_party>
  <!-- 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/NCT02198053
org study id: azliquan
nct id: NCT02198053
lead sponsor: 
has dmc: No
Different antiplatelet drugs played various role in coronary artery disease. The mechanisms
      were unclear. Platelet reactivation maybe was one of major causes. Compared with clopidogrel,
      Ticagrelor is more powerful antiplatelet drug. However, because of increased bleeding and
      dyspnea risk, both loading double dose and following second dose time had potential risk and
      inconvenient in routine clinical work, especially in elective PCI of comparable stable
      patients in Chinese. The benefit and risk should be balanced in such patients. The
      investigators supposed loading single dose and followed by second routine time dose was
      superior to clopidogrel and safer than ticagrelor previously prescribed.
All admission patients were divided into two groups, the first group were prescribed loading
      dose (180 mg) ticagrelor, the second group were prescribed with 90 mg ticagrelor. We measured
      both platelet activity and platelet reactivity using the LTA at baseline, pre-operation and
      post-operation. All bleeding or dyspnea events were recorded in hospital period.

      Primary endpoints: platelet activity, platelet reactivity using the LTA and safety events
      were recorded in hospital period.
observational model: Case-Control
time perspective: Prospective
measure: Platelet reactivity
time frame: 1 year
description: LTA and TEG used to measure the effect of Platelet reactivity
arm group label: Ticagrelor2
description: Ticagrelor with a loading dose of 180mg followed by 90 mg twice per day
arm group label: Ticagrelor1
description: Ticagrelor with a dose of 90mg followed by 90 mg twice per day .
Platelet reactivity
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: LI QUAN, doctor
role: Study Director
affiliation: Beijing Anzhen Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Anzhen Hospital
investigator full name: quan li
investigator title: associate chief physician