xml: <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/NCT05984537</url>
    </required_header>
    <id_info>
      <org_study_id>ZHENG Bo.</org_study_id>
      <nct_id>NCT05984537</nct_id>
    </id_info>
    <brief_title>A Study on the Impact of Bivalirudin Usage During PCI for High-risk Plaques on Post-PCI Coronary Microcirculation.</brief_title>
    <acronym>PCI</acronym>
    <official_title>A Study on the Impact of Bivalirudin Usage During Percutaneous Coronary Intervention for High-risk Plaques in the Coronary Artery on Post Percutaneous Coronary Intervention Coronary Microcirculation.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking University First Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking University First Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In this study, investigators enrolled patients with coronary heart disease who were scheduled&#xD;
        to undergo percutaneous coronary intervention (PCI) and had high-risk plaques according to&#xD;
        computed tomography angiography (CTA). During the PCI procedure, patients will be randomly&#xD;
        assigned to receive either bivalirudin or standard heparin anticoagulation therapy.&#xD;
        Investigators will compare the post-PCI coronary angiography-derived index of&#xD;
        microcirculatory resistance (CaIMR), thrombolysis in myocardial infarction (TIMI) blood flow&#xD;
        grade, CTFC (corrected TIMI frame count), TIMI myocardial perfusion grading(TMPG), levels of&#xD;
        troponin, and major adverse cardiac events (MACE) during a follow-up period of 6 months&#xD;
        between the two groups. Investigators aim to explore the potential benefits of bivalirudin&#xD;
        perioperative anticoagulation therapy in improving coronary microvascular dysfunction (CMD)&#xD;
        after PCI for high-risk plaques in coronary artery lesions.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Coronary artery disease (CAD) is one of the leading causes of death in China, with nearly&#xD;
        11.39 million patients affected. Percutaneous coronary intervention (PCI) is an important&#xD;
        treatment for CAD, but despite effectively improving coronary stenosis, patients still&#xD;
        experience the phenomenon of no-reflow (NR), which seriously affects long-term prognosis.&#xD;
        Coronary microvascular dysfunction (CMD) during PCI is an important mechanism of NR, and&#xD;
        previous studies have shown that immediate post-PCI CMD significantly affects long-term&#xD;
        prognosis. Previous studies have shown that high-risk plaques identified by computed&#xD;
        tomography angiography (CTA) before surgery in patients with stable coronary heart disease&#xD;
        are closely related to the occurrence of NR and can serve as a predictor of NR after PCI.&#xD;
        Therefore, CTA can identify high-risk patients for NR before PCI and has clinical value in&#xD;
        preventing NR. Bivalirudin is a direct thrombin inhibitor that can block the continued&#xD;
        development of blood clots. BIVAL study has shown that bivalirudin can improve post-PCI&#xD;
        microcirculation dysfunction in patients with acute ST-segment elevation myocardial&#xD;
        infarction, and animal experiments have shown that bivalirudin can improve thrombin-induced&#xD;
        endothelial hyperpermeability.&#xD;
  &#xD;
        In this study, investigators plan to identify high-risk coronary artery plaques early through&#xD;
        CTA examination. Participants will be randomly assigned to receive either bivalirudin or&#xD;
        standard heparin anticoagulation therapy. Investigators will compare the post-PCI CaIMR,&#xD;
        thrombolysis in myocardial infarction (TIMI) blood flow grade, CTFC (corrected TIMI frame&#xD;
        count), TIMI myocardial perfusion grading(TMPG), levels of troponin, and major adverse&#xD;
        cardiac events (MACE) during a follow-up period of 6 months between the two groups.&#xD;
        Investigators will also explore the possible mechanisms by which bivalirudin reduces coronary&#xD;
        microcirculatory injury and improves endothelial function through the detection of&#xD;
        endothelial function-related biomarkers, providing evidence for the multi-effectiveness of&#xD;
        bivalirudin in myocardial protection.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2024</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>single-center</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>single-blind</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>CaIMR</measure>
      <time_frame>3 days</time_frame>
      <description>The caIMR value of the target vessel immediately after PCI.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>CMD</measure>
      <time_frame>3 days</time_frame>
      <description>The proportion of target vessels with caIMR ≥ 25 and caIMR ≥ 40 immediately after PCI.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>clinical events</measure>
      <time_frame>6 months</time_frame>
      <description>(1) MACE (including cardiac death, target vessel revascularization, target vessel myocardial infarction, and heart failure readmission) at 30 days and 6 months after PCI; (2) Major adverse events (including all-cause death, non-fatal myocardial infarction, unplanned revascularization, definite or probable stent thrombosis, and clinically significant bleeding events) at 30 days and 6 months.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>biomarker_eNOs</measure>
      <time_frame>3 days</time_frame>
      <description>Serum levels of eNOs after PCI.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>biomarker_ET-1</measure>
      <time_frame>3 days</time_frame>
      <description>Serum levels of ET-1 after PCI.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>biomarker_myocardial injury markers</measure>
      <time_frame>3 days</time_frame>
      <description>Peak levels of myocardial injury markers (CK-MB and CTNI) after PCI.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>imaging examination_microcirculation</measure>
      <time_frame>3 days</time_frame>
      <description>Other indicators for assessing microcirculation during the procedure (including TMPG, TIMI frame count, and myocardial staining grade).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>imaging examination_longitudinal myocardial strain</measure>
      <time_frame>3 days</time_frame>
      <description>Changes in global longitudinal myocardial strain of the left ventricle measured by post-PCI echocardiography compared to baseline values.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Coronary Microvascular Dysfunction</condition>
    <arm_group>
      <arm_group_label>bivalirudin group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>participants using bivalirudin during PCI</description>
    </arm_group>
    <arm_group>
      <arm_group_label>standard heparin group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>participants using standard heparin during PCI</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bivalirudin</intervention_name>
      <description>Participants in the bivalirudin group received a one-time intravenous injection of 0.75 mg/kg during PCI, and then received a continuous intravenous infusion of 1.75 mg/kg/h for 4 hours according to the participants' condition after PCI.</description>
      <arm_group_label>bivalirudin group</arm_group_label>
      <other_name>bivalirudin anticoagulation</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>standard heparin</intervention_name>
      <description>Participants in the standard heparin group received a one-time intravenous injection of 50 U/kg of standard heparin during PCI.</description>
      <arm_group_label>standard heparin group</arm_group_label>
      <other_name>standard heparin anticoagulation</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. aged 18 years or older;&#xD;
  &#xD;
            2. diagnosed with non-ST-segment elevation myocardial infarction or unstable angina&#xD;
               pectoris;&#xD;
  &#xD;
            3. scheduled to undergo elective coronary angiography and intervention;&#xD;
  &#xD;
            4. coronary computed tomography angiography showing high-risk plaque features within 3&#xD;
               months prior to the procedure;&#xD;
  &#xD;
            5. voluntary participation in the study and signed informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. prior PCI of the target vessel within 3 months;&#xD;
  &#xD;
            2. cardiogenic shock, active bleeding, bleeding disorders, irreversible coagulation&#xD;
               dysfunction, severe liver dysfunction (Child-Pugh class C), severe renal dysfunction&#xD;
               (eGFR &lt; 30 ml/min/1.73m2), and dependence on dialysis;&#xD;
  &#xD;
            3. life expectancy less than 1 year;&#xD;
  &#xD;
            4. chronic total occlusion of the target vessel;&#xD;
  &#xD;
            5. poor opacification of the target vessel, severe vessel overlap or distortion, and&#xD;
               inability to completely expose the lesion site;&#xD;
  &#xD;
            6. allergy to contrast agents, verapamil, or its excipients;&#xD;
  &#xD;
            7. severe uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic&#xD;
               blood pressure ≥ 100 mmHg);&#xD;
  &#xD;
            8. subacute bacterial endocarditis.&#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>Bo Zheng, Prof</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peking University First Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Peking university first hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>10034</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Peking University First Hospital</investigator_affiliation>
      <investigator_full_name>ZHENG Bo</investigator_full_name>
      <investigator_title>associate professor</investigator_title>
    </responsible_party>
    <keyword>coronary microvascular dysfunction</keyword>
    <keyword>computed tomography angiography</keyword>
    <keyword>percutaneous coronary intervention</keyword>
    <keyword>bivalirudin</keyword>
    <keyword>heparin</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heparin</mesh_term>
      <mesh_term>Calcium heparin</mesh_term>
      <mesh_term>Hirudins</mesh_term>
      <mesh_term>Bivalirudin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05984537
  org study id: ZHENG Bo.
  nct id: NCT05984537
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  In this study, investigators enrolled patients with coronary heart disease who were scheduled
        to undergo percutaneous coronary intervention (PCI) and had high-risk plaques according to
        computed tomography angiography (CTA). During the PCI procedure, patients will be randomly
        assigned to receive either bivalirudin or standard heparin anticoagulation therapy.
        Investigators will compare the post-PCI coronary angiography-derived index of
        microcirculatory resistance (CaIMR), thrombolysis in myocardial infarction (TIMI) blood flow
        grade, CTFC (corrected TIMI frame count), TIMI myocardial perfusion grading(TMPG), levels of
        troponin, and major adverse cardiac events (MACE) during a follow-up period of 6 months
        between the two groups. Investigators aim to explore the potential benefits of bivalirudin
        perioperative anticoagulation therapy in improving coronary microvascular dysfunction (CMD)
        after PCI for high-risk plaques in coronary artery lesions.
  Coronary artery disease (CAD) is one of the leading causes of death in China, with nearly
        11.39 million patients affected. Percutaneous coronary intervention (PCI) is an important
        treatment for CAD, but despite effectively improving coronary stenosis, patients still
        experience the phenomenon of no-reflow (NR), which seriously affects long-term prognosis.
        Coronary microvascular dysfunction (CMD) during PCI is an important mechanism of NR, and
        previous studies have shown that immediate post-PCI CMD significantly affects long-term
        prognosis. Previous studies have shown that high-risk plaques identified by computed
        tomography angiography (CTA) before surgery in patients with stable coronary heart disease
        are closely related to the occurrence of NR and can serve as a predictor of NR after PCI.
        Therefore, CTA can identify high-risk patients for NR before PCI and has clinical value in
        preventing NR. Bivalirudin is a direct thrombin inhibitor that can block the continued
        development of blood clots. BIVAL study has shown that bivalirudin can improve post-PCI
        microcirculation dysfunction in patients with acute ST-segment elevation myocardial
        infarction, and animal experiments have shown that bivalirudin can improve thrombin-induced
        endothelial hyperpermeability.
  
        In this study, investigators plan to identify high-risk coronary artery plaques early through
        CTA examination. Participants will be randomly assigned to receive either bivalirudin or
        standard heparin anticoagulation therapy. Investigators will compare the post-PCI CaIMR,
        thrombolysis in myocardial infarction (TIMI) blood flow grade, CTFC (corrected TIMI frame
        count), TIMI myocardial perfusion grading(TMPG), levels of troponin, and major adverse
        cardiac events (MACE) during a follow-up period of 6 months between the two groups.
        Investigators will also explore the possible mechanisms by which bivalirudin reduces coronary
        microcirculatory injury and improves endothelial function through the detection of
        endothelial function-related biomarkers, providing evidence for the multi-effectiveness of
        bivalirudin in myocardial protection.
  allocation: Randomized
  intervention model: Single Group Assignment
  intervention model description: single-center
  primary purpose: Prevention
  masking: Single (Participant)
  masking description: single-blind
  measure: CaIMR
  time frame: 3 days
  description: The caIMR value of the target vessel immediately after PCI.
  measure: CMD
  time frame: 3 days
  description: The proportion of target vessels with caIMR ≥ 25 and caIMR ≥ 40 immediately after PCI.
  measure: clinical events
  time frame: 6 months
  description: (1) MACE (including cardiac death, target vessel revascularization, target vessel myocardial infarction, and heart failure readmission) at 30 days and 6 months after PCI; (2) Major adverse events (including all-cause death, non-fatal myocardial infarction, unplanned revascularization, definite or probable stent thrombosis, and clinically significant bleeding events) at 30 days and 6 months.
  measure: biomarker_eNOs
  time frame: 3 days
  description: Serum levels of eNOs after PCI.
  measure: biomarker_ET-1
  time frame: 3 days
  description: Serum levels of ET-1 after PCI.
  measure: biomarker_myocardial injury markers
  time frame: 3 days
  description: Peak levels of myocardial injury markers (CK-MB and CTNI) after PCI.
  measure: imaging examination_microcirculation
  time frame: 3 days
  description: Other indicators for assessing microcirculation during the procedure (including TMPG, TIMI frame count, and myocardial staining grade).
  measure: imaging examination_longitudinal myocardial strain
  time frame: 3 days
  description: Changes in global longitudinal myocardial strain of the left ventricle measured by post-PCI echocardiography compared to baseline values.
  arm group label: bivalirudin group
  arm group type: Experimental
  description: participants using bivalirudin during PCI
  arm group label: standard heparin group
  arm group type: Active Comparator
  description: participants using standard heparin during PCI
  intervention type: Drug
  intervention name: Bivalirudin
  description: Participants in the bivalirudin group received a one-time intravenous injection of 0.75 mg/kg during PCI, and then received a continuous intravenous infusion of 1.75 mg/kg/h for 4 hours according to the participants' condition after PCI.
  arm group label: bivalirudin group
  other name: bivalirudin anticoagulation
  intervention type: Drug
  intervention name: standard heparin
  description: Participants in the standard heparin group received a one-time intravenous injection of 50 U/kg of standard heparin during PCI.
  arm group label: standard heparin group
  other name: standard heparin anticoagulation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Bo Zheng, Prof
  role: Principal Investigator
  affiliation: Peking University First Hospital
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Peking University First Hospital
  investigator full name: ZHENG Bo
  investigator title: associate professor
  mesh term: Heparin
  mesh term: Calcium heparin
  mesh term: Hirudins
  mesh term: Bivalirudin
  sharing ipd: No