<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/NCT03797729</url>
  </required_header>
  <id_info>
    <org_study_id>TRYIT</org_study_id>
    <nct_id>NCT03797729</nct_id>
  </id_info>
  <brief_title>Early Initiation of Low Dose Tirofiban for PPCI in STEMI Patients.</brief_title>
  <official_title>Early Initiation of Low Dose Tirofiban for Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan Hospital</source>
  <oversight_info>
    <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>
      Anti-platelet therapy is a key point of acute myocardial infarction (AMI) treatment.&#xD;
      Nowadays, dual anti-platelet therapy based on aspirin and ADP-P2Y12 receptor inhibitor is the&#xD;
      preferred treatment before primary percutaneous coronary intervention (PPCI). Restricted by&#xD;
      pharmacokinetic and pharmacodynamic characteristics, ADP-P2Y12 receptor inhibitors cannot&#xD;
      take effect immediately after oral administration. However, platelet glycoprotein Ⅱb / Ⅲa&#xD;
      inhibitors take effect faster. Previous clinical trials indicated that combination of full&#xD;
      dose of glycoprotein Ⅱb / Ⅲa inhibitor and dual anti-platelet therapy reduced AMI related&#xD;
      ischemia events but increased bleeding events significantly. The high dose of glycoprotein Ⅱb&#xD;
      / Ⅲa inhibitor may be the key factor contributing to the increased bleeding events.&#xD;
      Therefore, this study aims to evaluate the effectiveness and security of triple anti-platelet&#xD;
      therapy based on a small dose of glycoprotein Ⅱb / Ⅲa inhibitor, aspirin and ADP-P2Y12&#xD;
      receptor inhibitor in AMI patients receiving PPCI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 14, 2019</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">June 2021</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>TFG(TIMI flow grades) grade III: complete myocardial perfusion immediately after primary percutaneous coronary intervention detected by DSA(Digital Substraction Angiography).</measure>
    <time_frame>Immediately after primary percutaneous coronary intervention.</time_frame>
    <description>TIMI flow grades: grade III.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>TMP(TIMI myocardial perfusion grades) grade III: complete myocardial perfusion immediately after primary percutaneous coronary intervention detected by DSA(Digital Substraction Angiography).</measure>
    <time_frame>Immediately after primary percutaneous coronary intervention.</time_frame>
    <description>TIMI myocardial perfusion grades: grade III.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Remedial Tirofiban intravenous use during primary percutaneous coronary intervention procedure.</measure>
    <time_frame>During the process of primary percutaneous coronary intervention.</time_frame>
    <description>Remedial Tirofiban use during primary percutaneous coronary intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ST segment</measure>
    <time_frame>90 minutes after primary percutaneous coronary intervention.</time_frame>
    <description>The sum of the initial ST segment elevation drops 70% or more.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial microcirculation perfusion estimated by cardiac magnetic (CMR).</measure>
    <time_frame>7 days after primary percutaneous coronary intervention.</time_frame>
    <description>Myocardial microcirculation perfusion estimated by cardiac magnetic resonance imaging.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiovascular events(MACE), including a composite of all-cause death, nonfatal myocardial infarction, stroke, target vessel revascularization.</measure>
    <time_frame>30 days after primary percutaneous coronary intervention.</time_frame>
    <description>Major adverse cardiovascular events, including a composite of all-cause death, nonfatal myocardial infarction, stroke, target vessel revascularization.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Left ventricular ejection fraction (LVEF) assessed by transthoracic echocardiography.</measure>
    <time_frame>7 and 30 days after primary percutaneous coronary intervention.</time_frame>
    <description>Left ventricular ejection fraction assessed by transthoracic echocardiography.</description>
  </other_outcome>
  <other_outcome>
    <measure>The serum microRNA expression pattern changes after primary percutaneous coronary intervention.</measure>
    <time_frame>Pre-, 30 minutes, 3 hours and 24 hours after primary percutaneous coronary intervention.</time_frame>
    <description>The microRNA expression pattern changes.</description>
  </other_outcome>
  <other_outcome>
    <measure>All the bleeding events assessed by bleeding academic research consortium(BARC) definition for bleeding)</measure>
    <time_frame>30 days after primary percutaneous coronary intervention.</time_frame>
    <description>All the bleeding events assessed by bleeding academic research consortium(BARC) definition for bleeding)</description>
  </other_outcome>
  <other_outcome>
    <measure>Major bleeding events assessed by TIMI bleeding criteria.</measure>
    <time_frame>30 days after primary percutaneous coronary intervention.</time_frame>
    <description>Any intracranial bleeding (excluding microhemorrhages &lt;10 mm evident only on gradient-echo MRI); Clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥ 5 g/dL; Fatal bleeding (bleeding that directly results in death within 7 d).</description>
  </other_outcome>
  <other_outcome>
    <measure>Severe or life-threatening and moderate bleeding events assessed by GUSTO bleeding criteria.</measure>
    <time_frame>30 days after primary percutaneous coronary intervention.</time_frame>
    <description>GUSTO bleeding criteria:Severe or life-threatening :&#xD;
Intracerebral hemorrhage ; Resulting in substantial hemodynamic compromise requiring treatment.&#xD;
Moderate:&#xD;
Requiring blood transfusion but not resulting in hemodynamic compromise.&#xD;
Mild :&#xD;
Bleeding that does not meet above criteria.</description>
  </other_outcome>
  <other_outcome>
    <measure>Major bleeding events assessed by international society on thrombosis and haemostasis(ISTH) bleeding criteria.</measure>
    <time_frame>30 days after primary percutaneous coronary intervention.</time_frame>
    <description>Fatal bleeding and/or symptomatic bleeding in a critical area or organ such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing hemoglobin drop of 20 g/L or more, and/or blood transfusion of 2 units or more</description>
  </other_outcome>
  <other_outcome>
    <measure>Adverse events and severe adverse events.</measure>
    <time_frame>30 days after primary percutaneous coronary intervention.</time_frame>
    <description>Adverse events and severe adverse events.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>ST Elevation Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Normal saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Tirofiban</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tirofiban</intervention_name>
    <description>Upon being diagnosed as ST Elevation Myocardial Infarction, if informed consent is obtained, patients start to receive Tirofiban(0.05mg/ml) intravenous drip in a dosage of 4ml/hour (patients weight&lt;50kg) or 6ml/hour (patients weight &gt; 50kg) lasting for 24 hours.</description>
    <arm_group_label>Tirofiban</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>Upon being diagnosed as ST Elevation Myocardial Infarction, if informed consent is obtained, patients start to receive normal saline intravenous drip in a dosage of 4ml/hour (patients weight&lt;50kg) or 6ml/hour (patients weight &gt; 50kg) lasting for 24 hours.</description>
    <arm_group_label>Normal saline</arm_group_label>
    <other_name>Sodium Chloride Injection</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Time after onset of chest pain: ≥ 30 minutes and ≤ 24 hours;&#xD;
&#xD;
          -  ST segment elevated ≥ 0.1mV in adjacent two or more leads;&#xD;
&#xD;
          -  Scheduled for primary percutaneous coronary intervention without contraindications;&#xD;
&#xD;
          -  Written informed consent is obtained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Life expectancy ≤ 1 year;&#xD;
&#xD;
          -  History of cerebral hemorrhage;&#xD;
&#xD;
          -  History of stroke in 6 months;&#xD;
&#xD;
          -  Active hemorrhage;&#xD;
&#xD;
          -  Severe hepatic and renal dysfunction(ALT &gt; 3 folds of upper limit of normal, eGFR &lt;&#xD;
             30ml/min/1.73mm^2 or Scr &gt; 200 mmol/L);&#xD;
&#xD;
          -  Known hemorrhagic diseases;&#xD;
&#xD;
          -  Known malignant tumour diseases；&#xD;
&#xD;
          -  Active peptic ulcer disease;&#xD;
&#xD;
          -  Blood platelet counts &lt; 100×10^9/L;&#xD;
&#xD;
          -  Blood hemoglobin &lt; 90g/L;&#xD;
&#xD;
          -  Pregnancy or lactation period；&#xD;
&#xD;
          -  Take part in other intervention clinical trials；&#xD;
&#xD;
          -  Investigators think not suitable to participate in this trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juying Qian, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhangwei Chen, MD</last_name>
    <phone>+8602164041990</phone>
    <phone_ext>612747</phone_ext>
    <email>chen.zhangwei@zs-hospital.sh.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hongyi Wu, MD</last_name>
    <phone>+8602164041990</phone>
    <email>wu.hongyi@zs-hospital.sh.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Zhongshan Hospital Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhangwei Chen, MD</last_name>
      <phone>+86 21 64041990</phone>
      <email>chen.zhangwei@zs-hospital.sh.cn</email>
    </contact>
    <contact_backup>
      <last_name>Danbo Lu, PhD</last_name>
      <phone>+86 21 64041990</phone>
      <email>lu.danbo@zs-hospital.sh.cn</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 1, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>January 20, 2020</last_update_submitted>
  <last_update_submitted_qc>January 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ST Elevation Myocardial Infarction</keyword>
  <keyword>Tirofiban</keyword>
  <keyword>Percutaneous Coronary Intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>ST Elevation Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tirofiban</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03797729
org study id: TRYIT
nct id: NCT03797729
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Anti-platelet therapy is a key point of acute myocardial infarction (AMI) treatment.
      Nowadays, dual anti-platelet therapy based on aspirin and ADP-P2Y12 receptor inhibitor is the
      preferred treatment before primary percutaneous coronary intervention (PPCI). Restricted by
      pharmacokinetic and pharmacodynamic characteristics, ADP-P2Y12 receptor inhibitors cannot
      take effect immediately after oral administration. However, platelet glycoprotein Ⅱb / Ⅲa
      inhibitors take effect faster. Previous clinical trials indicated that combination of full
      dose of glycoprotein Ⅱb / Ⅲa inhibitor and dual anti-platelet therapy reduced AMI related
      ischemia events but increased bleeding events significantly. The high dose of glycoprotein Ⅱb
      / Ⅲa inhibitor may be the key factor contributing to the increased bleeding events.
      Therefore, this study aims to evaluate the effectiveness and security of triple anti-platelet
      therapy based on a small dose of glycoprotein Ⅱb / Ⅲa inhibitor, aspirin and ADP-P2Y12
      receptor inhibitor in AMI patients receiving PPCI.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: TFG(TIMI flow grades) grade III: complete myocardial perfusion immediately after primary percutaneous coronary intervention detected by DSA(Digital Substraction Angiography).
time frame: Immediately after primary percutaneous coronary intervention.
description: TIMI flow grades: grade III.
measure: TMP(TIMI myocardial perfusion grades) grade III: complete myocardial perfusion immediately after primary percutaneous coronary intervention detected by DSA(Digital Substraction Angiography).
time frame: Immediately after primary percutaneous coronary intervention.
description: TIMI myocardial perfusion grades: grade III.
measure: Remedial Tirofiban intravenous use during primary percutaneous coronary intervention procedure.
time frame: During the process of primary percutaneous coronary intervention.
description: Remedial Tirofiban use during primary percutaneous coronary intervention.
measure: ST segment
time frame: 90 minutes after primary percutaneous coronary intervention.
description: The sum of the initial ST segment elevation drops 70% or more.
measure: Myocardial microcirculation perfusion estimated by cardiac magnetic (CMR).
time frame: 7 days after primary percutaneous coronary intervention.
description: Myocardial microcirculation perfusion estimated by cardiac magnetic resonance imaging.
measure: Major adverse cardiovascular events(MACE), including a composite of all-cause death, nonfatal myocardial infarction, stroke, target vessel revascularization.
time frame: 30 days after primary percutaneous coronary intervention.
description: Major adverse cardiovascular events, including a composite of all-cause death, nonfatal myocardial infarction, stroke, target vessel revascularization.
measure: Left ventricular ejection fraction (LVEF) assessed by transthoracic echocardiography.
time frame: 7 and 30 days after primary percutaneous coronary intervention.
description: Left ventricular ejection fraction assessed by transthoracic echocardiography.
measure: The serum microRNA expression pattern changes after primary percutaneous coronary intervention.
time frame: Pre-, 30 minutes, 3 hours and 24 hours after primary percutaneous coronary intervention.
description: The microRNA expression pattern changes.
measure: All the bleeding events assessed by bleeding academic research consortium(BARC) definition for bleeding)
time frame: 30 days after primary percutaneous coronary intervention.
description: All the bleeding events assessed by bleeding academic research consortium(BARC) definition for bleeding)
measure: Major bleeding events assessed by TIMI bleeding criteria.
time frame: 30 days after primary percutaneous coronary intervention.
description: Any intracranial bleeding (excluding microhemorrhages <10 mm evident only on gradient-echo MRI); Clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥ 5 g/dL; Fatal bleeding (bleeding that directly results in death within 7 d).
measure: Severe or life-threatening and moderate bleeding events assessed by GUSTO bleeding criteria.
time frame: 30 days after primary percutaneous coronary intervention.
description: GUSTO bleeding criteria:Severe or life-threatening :
Intracerebral hemorrhage ; Resulting in substantial hemodynamic compromise requiring treatment.
Moderate:
Requiring blood transfusion but not resulting in hemodynamic compromise.
Mild :
Bleeding that does not meet above criteria.
measure: Major bleeding events assessed by international society on thrombosis and haemostasis(ISTH) bleeding criteria.
time frame: 30 days after primary percutaneous coronary intervention.
description: Fatal bleeding and/or symptomatic bleeding in a critical area or organ such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing hemoglobin drop of 20 g/L or more, and/or blood transfusion of 2 units or more
measure: Adverse events and severe adverse events.
time frame: 30 days after primary percutaneous coronary intervention.
description: Adverse events and severe adverse events.
arm group label: Normal saline
arm group type: Placebo Comparator
arm group label: Tirofiban
arm group type: Experimental
intervention type: Drug
intervention name: Tirofiban
description: Upon being diagnosed as ST Elevation Myocardial Infarction, if informed consent is obtained, patients start to receive Tirofiban(0.05mg/ml) intravenous drip in a dosage of 4ml/hour (patients weight<50kg) or 6ml/hour (patients weight > 50kg) lasting for 24 hours.
arm group label: Tirofiban
intervention type: Drug
intervention name: Normal saline
description: Upon being diagnosed as ST Elevation Myocardial Infarction, if informed consent is obtained, patients start to receive normal saline intravenous drip in a dosage of 4ml/hour (patients weight<50kg) or 6ml/hour (patients weight > 50kg) lasting for 24 hours.
arm group label: Normal saline
other name: Sodium Chloride Injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Juying Qian, MD
role: Study Chair
affiliation: Fudan University
last name: Zhangwei Chen, MD
phone: +8602164041990
phone ext: 612747
email: chen.zhangwei@zs-hospital.sh.cn
last name: Hongyi Wu, MD
phone: +8602164041990
email: wu.hongyi@zs-hospital.sh.cn
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction
mesh term: Tirofiban
sharing ipd: No