<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/NCT03758248</url>
  </required_header>
  <id_info>
    <org_study_id>Gene Polymorphism</org_study_id>
    <nct_id>NCT03758248</nct_id>
  </id_info>
  <brief_title>The Influence of Gene Polymorphism on Clinical Outcomes in Patients Undergoing PCI</brief_title>
  <official_title>The Influence of Gene Polymorphism on Clinical Outcomes in Patients Undergoing 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>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dual antiplatelet therapy with aspirin and thienopyridines is an essential treatment in&#xD;
      patients undergoing percutaneous coronary intervention (PCI). However, despite intensified&#xD;
      antiplatelet treatment, some of the patients undergoing PCI develop thrombotic stent&#xD;
      occlusion, suggesting incomplete platelet inhibition due to thienopyridine resistance. Some&#xD;
      patients develop bleeding event because of the improper dosage and covariation. This&#xD;
      observational study is designed for clarifying the Influence of gene polymorphism on clinical&#xD;
      outcomes in patients undergoing PCI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients undergoing PCI who received dual antiplatelet therapy with both aspirin (100mg) and&#xD;
      P2Y12 inhibitors in standard dosage were enrolled. Investigators examined plasma biomarkers&#xD;
      for platelet activation and DNA in those patients, and then analyzed the CYP2C19 genetic&#xD;
      polymorphism to examine the influence of this genetic variation on the several biomarkers for&#xD;
      platelet activation and bleeding event.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">September 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Patients with treatment-related major bleeding event as assessed by the Bleeding Academic Research Consortium (BARC) bleeding criteria</measure>
    <time_frame>up to 24 months</time_frame>
    <description>The major bleeding event was a composite endpoint of BARC bleeding type 3 and 5), defined according to the BARC bleeding criteria, which was used widely in this field. BARC bleeding was defined as follows: BARC type 1, any bleeding that is not actionable; type 2, any overt, actionable sign of bleeding; type 3a, overt bleeding with a haemoglobin drop of 3-5 g/dL or any transfusion; type 3b, overt bleeding with a haemoglobin drop &gt;5 g/dL, requiring vasopressors, surgical intervention, or due to cardiac tamponade; type 3c, any intracranial or intraocular bleeding; and finally type 5, any bleeding resulting in death (type 4 was coronary artery bypass graft-related bleeding, which was excluded). Investigator will get all the information through regular return visit and telephone follow-up after discharge.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiac events (MACE)</measure>
    <time_frame>up to 24 months</time_frame>
    <description>A composite of death, myocardial infarction, stroke, stent thrombosis, and ischemia-driven revascularization</description>
  </secondary_outcome>
  <enrollment type="Anticipated">12000</enrollment>
  <condition>Antiplatelet Therapy</condition>
  <condition>CYP2C19 Polymorphism</condition>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>CYP2C19</intervention_name>
    <description>The CYP2C19 enzyme plays a vital role in the two bioactivation steps of clopidogrel leading to lower (CYP2C19*17 carriers) or higher (CYP2C19*2 carriers) risk of major adverse cardiovascular events.</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Gene polymorphism is measured by using whole blood in patients undergoing PCI.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        PCI patients in Beijing Anzhen Hospital from August 2018 to August 2019&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The patients undergoing PCI&#xD;
&#xD;
          2. More than 18 years old&#xD;
&#xD;
          3. Treated with aspirin and P2Y12 inhibitors (clopidogrel or ticagrelor)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Inability to provide written informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yujie Zhou, PhD,MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Anzhen Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yujie Zhou, PhD,MD</last_name>
    <phone>8613901330652</phone>
    <email>azzyj12@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beijing Anzhen Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yujie Zhou, MD, PhD</last_name>
      <phone>8613901330652</phone>
      <email>azzyj12@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Yujing Cheng, MD</last_name>
      <phone>8613426481193</phone>
      <email>13426481193@163.com</email>
    </contact_backup>
    <investigator>
      <last_name>Yujie Zhou, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>December 4, 2020</last_update_submitted>
  <last_update_submitted_qc>December 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Anzhen Hospital</investigator_affiliation>
    <investigator_full_name>Yujie Zhou</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Genotype-guided therapy</keyword>
  <keyword>CYP2C19 Polymorphism</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03758248
org study id: Gene Polymorphism
nct id: NCT03758248
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Dual antiplatelet therapy with aspirin and thienopyridines is an essential treatment in
      patients undergoing percutaneous coronary intervention (PCI). However, despite intensified
      antiplatelet treatment, some of the patients undergoing PCI develop thrombotic stent
      occlusion, suggesting incomplete platelet inhibition due to thienopyridine resistance. Some
      patients develop bleeding event because of the improper dosage and covariation. This
      observational study is designed for clarifying the Influence of gene polymorphism on clinical
      outcomes in patients undergoing PCI.
Patients undergoing PCI who received dual antiplatelet therapy with both aspirin (100mg) and
      P2Y12 inhibitors in standard dosage were enrolled. Investigators examined plasma biomarkers
      for platelet activation and DNA in those patients, and then analyzed the CYP2C19 genetic
      polymorphism to examine the influence of this genetic variation on the several biomarkers for
      platelet activation and bleeding event.
observational model: Cohort
time perspective: Other
measure: Patients with treatment-related major bleeding event as assessed by the Bleeding Academic Research Consortium (BARC) bleeding criteria
time frame: up to 24 months
description: The major bleeding event was a composite endpoint of BARC bleeding type 3 and 5), defined according to the BARC bleeding criteria, which was used widely in this field. BARC bleeding was defined as follows: BARC type 1, any bleeding that is not actionable; type 2, any overt, actionable sign of bleeding; type 3a, overt bleeding with a haemoglobin drop of 3-5 g/dL or any transfusion; type 3b, overt bleeding with a haemoglobin drop >5 g/dL, requiring vasopressors, surgical intervention, or due to cardiac tamponade; type 3c, any intracranial or intraocular bleeding; and finally type 5, any bleeding resulting in death (type 4 was coronary artery bypass graft-related bleeding, which was excluded). Investigator will get all the information through regular return visit and telephone follow-up after discharge.
measure: Major adverse cardiac events (MACE)
time frame: up to 24 months
description: A composite of death, myocardial infarction, stroke, stent thrombosis, and ischemia-driven revascularization
intervention type: Genetic
intervention name: CYP2C19
description: The CYP2C19 enzyme plays a vital role in the two bioactivation steps of clopidogrel leading to lower (CYP2C19*17 carriers) or higher (CYP2C19*2 carriers) risk of major adverse cardiovascular events.
Gene polymorphism is measured by using whole blood in patients undergoing PCI.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yujie Zhou, PhD,MD
role: Principal Investigator
affiliation: Beijing Anzhen Hospital
last name: Yujie Zhou, PhD,MD
phone: 8613901330652
email: azzyj12@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Anzhen Hospital
investigator full name: Yujie Zhou
investigator title: Professor
sharing ipd: Undecided