<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/NCT03230851</url>
  </required_header>
  <id_info>
    <org_study_id>006</org_study_id>
    <nct_id>NCT03230851</nct_id>
  </id_info>
  <brief_title>the Efficacy and Safety of Indobufen and Low-dose Aspirin in Different Regimens of Antiplatelet Therapy</brief_title>
  <official_title>the Efficacy and Safety of Indobufen and Low-dose Aspirin in Different Regimens of Antiplatelet Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital with Nanjing Medical University</source>
  <oversight_info>
    <has_dmc>No</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>
      A total of 210 coronary atherosclerosis patients without indications for stent implantation&#xD;
      are included. The baseline values of platelet aggregation rate, plasmaThromboxaneB2 and&#xD;
      urinary 11-dh ThromboxaneB2 are measured by Light Transmittance Aggregometry method and ELISA&#xD;
      after aspirin 100 mg /d ≥5d. Then the patients are randomly divided into 7 groups: Group1:&#xD;
      aspirin 100 mg/d; Group2: aspirin 100 mg /2d; Groups3: aspirin 100 mg / 3d; Groups4: morning&#xD;
      50mg evening 50mg; Group5: aspirin 75mg / d; Group6: aspirin 50mg / d; Group7: indobufen100mg&#xD;
      bid. One month later,arachidonic acid-induced platelet aggregation rate , plasma TXB2 and&#xD;
      urine 11-dh TXB2 are analyzed again. All patients are followed-up for 1 year. The stomach&#xD;
      Intestinal reactions, small bleeding events are recorded.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 210 coronary atherosclerosis patients without indications for stent implantation&#xD;
      are included. Exclusion criteria：Aspirin resistance, uncontrolled hypertension (&gt; 160 /&#xD;
      100mmHg),hemoglobin concentration &lt;100g /L, hemorrhagic disease or a history of bleeding&#xD;
      tendency, taking other nonsteroidal drugs, severe liver disease history, malignant tumor,&#xD;
      active gastric mucosa bleeding, percutaneous coronary intervention history, coronary artery&#xD;
      bypass surgery, cardiac function grade Ⅳ.The baseline values of platelet aggregation rate,&#xD;
      plasma TXB2 and urinary 11-dh TXB2 are measured by LTA method and ELISA after aspirin 100 mg&#xD;
      /d ≥5d. Then the patients are randomly divided into 7 groups: Group1: aspirin 100 mg/d;&#xD;
      Group2: aspirin 100 mg /2d; Groups3: aspirin 100 mg / 3d; Groups4: morning 50mg evening 50mg;&#xD;
      Group5: aspirin 75mg / d; Group6: aspirin 50mg / d; Group7: indobufen100mg bid. One month&#xD;
      later,arachidonic acid-induced platelet aggregation rate , plasma TXB2 and urine 11-dh TXB2&#xD;
      are analyzed again. All patients are followed-up for 1month,6months and1 year. The stomach&#xD;
      Intestinal reactions, small bleeding events ,whether to take proton pump inhibitors are&#xD;
      recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 20, 2017</start_date>
  <completion_date type="Anticipated">August 10, 2018</completion_date>
  <primary_completion_date type="Anticipated">July 10, 2018</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>platelet aggregation</measure>
    <time_frame>2 hours</time_frame>
    <description>Regional differences between blood samples from each subjects of different groups by LTA.The results of LTA are reported in platelet aggregation rate(%).Platelet aggregation was induced by0.5mg/ml arachidonic acid (AA).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>plasma thromboxaneB2</measure>
    <time_frame>3montshs</time_frame>
    <description>The plasma thromboxane B2 concentration of each subjects are measured by enzyme-linked immunosorbent assay .(cayman chemical, thromboxaneB2 express EIA kit-Monoclonal)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>urine 11-dehydro thromboxaneB2</measure>
    <time_frame>3 months</time_frame>
    <description>The urine 11-dehydro thromboxane B2 concentration of each subjects are measured by ELISA.(cayman chemical,11-dehydro thromboxaneB2 ELISA kit-Monoclonal)</description>
  </primary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Anticipated">210</enrollment>
  <condition>Coronary Atherosclerosis</condition>
  <arm_group>
    <arm_group_label>aspirin 100mg/d therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group1: aspirin 100 mg/d;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>aspirin 100mg/2d therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group2: aspirin ;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>aspirin 100mg/3d therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Groups3: aspirin ;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>aspirin 50mg bid therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Groups4: morning 50mg evening 50mg;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>aspirin 75mg/d therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group5: aspirin 75mg / d;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>aspirin 50mg/d therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group6: aspirin 50mg / d;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>indobufen 100mg bid therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group7: 100mg bid</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>aspirin 100mg/d therapy</intervention_name>
    <description>100mg aspirin for at least 5 days followed by aspirin 100mg/d</description>
    <arm_group_label>aspirin 100mg/d therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>aspirin 100mg/2d therapy</intervention_name>
    <description>100mg aspirin for at least 5 days followed by aspirin 100mg/2d</description>
    <arm_group_label>aspirin 100mg/2d therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>aspirin 100mg/3d therapy</intervention_name>
    <description>100mg aspirin for at least 5 days followed by aspirin 100mg/3d</description>
    <arm_group_label>aspirin 100mg/3d therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>aspirin 50mg bid therapy</intervention_name>
    <description>100mg aspirin for at least 5 days followed by aspirin 50mg bid</description>
    <arm_group_label>aspirin 50mg bid therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>aspirin 75mg/d therapy</intervention_name>
    <description>100mg aspirin for at least 5 days followed by aspirin 75mg/d</description>
    <arm_group_label>aspirin 75mg/d therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>aspirin 50mg/d therapy</intervention_name>
    <description>100mg aspirin for at least 5 days followed by aspirin 50mg/d</description>
    <arm_group_label>aspirin 50mg/d therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>indobufen 100mg bid therapy</intervention_name>
    <description>100mg aspirin for at least 5 days followed by indobufen 100mg bid</description>
    <arm_group_label>indobufen 100mg bid therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Clinical diagnosis of coronary atherosclerosis without indications for stent implantation .&#xD;
&#xD;
        Patient aged &gt;18 years and ≤75years. Must be able to swallow tablets&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Aspirin resistance; uncontrolled hypertension (&gt; 160 / 100mmHg); hemoglobin &lt;100g / L;&#xD;
        hemorrhagic disease or bleeding tendency history; taking other non-steroidal drugs; severe&#xD;
        liver disease history; malignant neoplasms; active gastric mucosa bleeding; PCI history;&#xD;
        coronary artery bypass surgery; cardiac function grade Ⅳ.&#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_contact>
    <last_name>Li Chunjian, Ph.D</last_name>
    <phone>+86-25-83718836</phone>
    <phone_ext>6018</phone_ext>
    <email>lijay@njmu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mei Lianlian</last_name>
    <phone>17766092046</phone>
    <email>Maylianlian1989@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>First Affiliated Hospital of Nanjing Medical University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>July 27, 2017</last_update_submitted>
  <last_update_submitted_qc>July 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First Affiliated Hospital with Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>Chunjian Li</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>Light Transmittance Aggregometry</keyword>
  <keyword>Indobufen</keyword>
  <keyword>Aspirin</keyword>
  <keyword>Plasma Thromboxane</keyword>
  <keyword>Urine 11-dehydro thromboxane</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
    <mesh_term>Indobufen</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>August 20, 2020</submitted>
    <returned>September 9, 2020</returned>
  </pending_results>
  <!-- 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/NCT03230851
org study id: 006
nct id: NCT03230851
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
A total of 210 coronary atherosclerosis patients without indications for stent implantation
      are included. The baseline values of platelet aggregation rate, plasmaThromboxaneB2 and
      urinary 11-dh ThromboxaneB2 are measured by Light Transmittance Aggregometry method and ELISA
      after aspirin 100 mg /d ≥5d. Then the patients are randomly divided into 7 groups: Group1:
      aspirin 100 mg/d; Group2: aspirin 100 mg /2d; Groups3: aspirin 100 mg / 3d; Groups4: morning
      50mg evening 50mg; Group5: aspirin 75mg / d; Group6: aspirin 50mg / d; Group7: indobufen100mg
      bid. One month later,arachidonic acid-induced platelet aggregation rate , plasma TXB2 and
      urine 11-dh TXB2 are analyzed again. All patients are followed-up for 1 year. The stomach
      Intestinal reactions, small bleeding events are recorded.
A total of 210 coronary atherosclerosis patients without indications for stent implantation
      are included. Exclusion criteria：Aspirin resistance, uncontrolled hypertension (> 160 /
      100mmHg),hemoglobin concentration <100g /L, hemorrhagic disease or a history of bleeding
      tendency, taking other nonsteroidal drugs, severe liver disease history, malignant tumor,
      active gastric mucosa bleeding, percutaneous coronary intervention history, coronary artery
      bypass surgery, cardiac function grade Ⅳ.The baseline values of platelet aggregation rate,
      plasma TXB2 and urinary 11-dh TXB2 are measured by LTA method and ELISA after aspirin 100 mg
      /d ≥5d. Then the patients are randomly divided into 7 groups: Group1: aspirin 100 mg/d;
      Group2: aspirin 100 mg /2d; Groups3: aspirin 100 mg / 3d; Groups4: morning 50mg evening 50mg;
      Group5: aspirin 75mg / d; Group6: aspirin 50mg / d; Group7: indobufen100mg bid. One month
      later,arachidonic acid-induced platelet aggregation rate , plasma TXB2 and urine 11-dh TXB2
      are analyzed again. All patients are followed-up for 1month,6months and1 year. The stomach
      Intestinal reactions, small bleeding events ,whether to take proton pump inhibitors are
      recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: platelet aggregation
time frame: 2 hours
description: Regional differences between blood samples from each subjects of different groups by LTA.The results of LTA are reported in platelet aggregation rate(%).Platelet aggregation was induced by0.5mg/ml arachidonic acid (AA).
measure: plasma thromboxaneB2
time frame: 3montshs
description: The plasma thromboxane B2 concentration of each subjects are measured by enzyme-linked immunosorbent assay .(cayman chemical, thromboxaneB2 express EIA kit-Monoclonal)
measure: urine 11-dehydro thromboxaneB2
time frame: 3 months
description: The urine 11-dehydro thromboxane B2 concentration of each subjects are measured by ELISA.(cayman chemical,11-dehydro thromboxaneB2 ELISA kit-Monoclonal)
arm group label: aspirin 100mg/d therapy
arm group type: Experimental
description: Group1: aspirin 100 mg/d;
arm group label: aspirin 100mg/2d therapy
arm group type: Experimental
description: Group2: aspirin ;
arm group label: aspirin 100mg/3d therapy
arm group type: Experimental
description: Groups3: aspirin ;
arm group label: aspirin 50mg bid therapy
arm group type: Experimental
description: Groups4: morning 50mg evening 50mg;
arm group label: aspirin 75mg/d therapy
arm group type: Experimental
description: Group5: aspirin 75mg / d;
arm group label: aspirin 50mg/d therapy
arm group type: Experimental
description: Group6: aspirin 50mg / d;
arm group label: indobufen 100mg bid therapy
arm group type: Experimental
description: Group7: 100mg bid
intervention type: Drug
intervention name: aspirin 100mg/d therapy
description: 100mg aspirin for at least 5 days followed by aspirin 100mg/d
arm group label: aspirin 100mg/d therapy
intervention type: Drug
intervention name: aspirin 100mg/2d therapy
description: 100mg aspirin for at least 5 days followed by aspirin 100mg/2d
arm group label: aspirin 100mg/2d therapy
intervention type: Drug
intervention name: aspirin 100mg/3d therapy
description: 100mg aspirin for at least 5 days followed by aspirin 100mg/3d
arm group label: aspirin 100mg/3d therapy
intervention type: Drug
intervention name: aspirin 50mg bid therapy
description: 100mg aspirin for at least 5 days followed by aspirin 50mg bid
arm group label: aspirin 50mg bid therapy
intervention type: Drug
intervention name: aspirin 75mg/d therapy
description: 100mg aspirin for at least 5 days followed by aspirin 75mg/d
arm group label: aspirin 75mg/d therapy
intervention type: Drug
intervention name: aspirin 50mg/d therapy
description: 100mg aspirin for at least 5 days followed by aspirin 50mg/d
arm group label: aspirin 50mg/d therapy
intervention type: Drug
intervention name: indobufen 100mg bid therapy
description: 100mg aspirin for at least 5 days followed by indobufen 100mg bid
arm group label: indobufen 100mg bid therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Li Chunjian, Ph.D
phone: +86-25-83718836
phone ext: 6018
email: lijay@njmu.edu.cn
last name: Mei Lianlian
phone: 17766092046
email: Maylianlian1989@163.com
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The First Affiliated Hospital with Nanjing Medical University
investigator full name: Chunjian Li
investigator title: professor
mesh term: Atherosclerosis
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Aspirin
mesh term: Indobufen
submitted: August 20, 2020
returned: September 9, 2020