<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <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/NCT03239067</url>
  </required_header>
  <id_info>
    <org_study_id>TJH-COSTIC</org_study_id>
    <nct_id>NCT03239067</nct_id>
  </id_info>
  <brief_title>Comparison Of Efficacy and Safety Between Ticagrelor and Clopidogrel In Chinese</brief_title>
  <acronym>COSTIC</acronym>
  <official_title>Comparison of Short- and Long-term Efficacy and Safety Between Ticagrelor and Clopidogrel in Chinese Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tongji Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tongji Hospital</source>
  <brief_summary>
    <textblock>
      This is a prospective, single-center study to assess the long- and short-term outcomes of&#xD;
      ticagrelor vs clopidogrel in Chinese patients with acute coronary syndrome undergoing&#xD;
      percutaneous coronary intervention. Patients will undergo face-to-face interviews, phone&#xD;
      calls, or/and chart reviews at 7 days, 1 month, 6 months and 12 months. When 4500 patients&#xD;
      have completed the follow-up, an interim analysis will be performed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2014</start_date>
  <completion_date type="Actual">October 24, 2021</completion_date>
  <primary_completion_date type="Actual">October 24, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Composite incidence of vascular death, myocardial infarction and stroke</measure>
    <time_frame>up to 12 months</time_frame>
    <description>Vascular death was defined as death from cardiovascular causes or cerebrovascular causes and any unknown death unless there was another certain cause.&#xD;
The definition of myocardial infarction was consistent with the Third Universal Definition of Myocardial Infarction (1).&#xD;
Stroke was defined as a rapid onset of a new focal loss of neurologic function caused by an ischemic central nervous system event with residual symptoms lasting at least 24 hours from their onset or leading to death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Composite incidence of all-cause death, myocardial infarction and stroke</measure>
    <time_frame>up to 12 months</time_frame>
    <description>All-cause death was defined as any death at hospital or after discharge.&#xD;
The definition of myocardial infarction was consistent with the Third Universal Definition of Myocardial Infarction.&#xD;
Stroke was defined as a rapid onset of a new focal loss of neurologic function caused by an ischemic central nervous system event with residual symptoms lasting at least 24 hours from their onset or leading to death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite incidence of vascular death, myocardial infarction, stroke, recurrent ischemia, transient ischemic attack, or other arterial thrombotic events</measure>
    <time_frame>up to 12 months</time_frame>
    <description>Vascular death was defined as death from cardiovascular causes or cerebrovascular causes and any unknown death unless there was another certain cause.&#xD;
The definition of myocardial infarction was consistent with the Third Universal Definition of Myocardial Infarction (1).&#xD;
Stroke was defined as a rapid onset of a new focal loss of neurologic function caused by an ischemic central nervous system event with residual symptoms lasting at least 24 hours from their onset or leading to death.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence of safety endpoints</measure>
    <time_frame>up to 12 months</time_frame>
    <description>Safety endpoints were defined according to the TIMI bleeding criteria.(2) Major bleeding (not related to heart surgery) was defined as fatal-, or intracranial bleeding including any clinically overt signs of hemorrhage associated with a decreased hemoglobin levels (≥5g/dl). Minor bleeding was defined as any clinically overt bleeding leading to decrease in hemoglobin levels of 3 to 5 g/dL or any bleeding requiring medical intervention. Minimal bleeding was defined as any overt bleeding event that did not meet the above criteria. An independent blinded central committee adjudicated all suspected endpoint event.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">9040</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <arm_group>
    <arm_group_label>ticagrelor group</arm_group_label>
    <description>patients prescribed with ticagrelor</description>
  </arm_group>
  <arm_group>
    <arm_group_label>clopidogrel group</arm_group_label>
    <description>patients prescribed with clopidogrel</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Chinese patients with acute coronary syndrome undergoing percutaneous coronary syndrome&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 years of age or older;&#xD;
&#xD;
          2. diagnosed as acute coronary syndrome;&#xD;
&#xD;
          3. underwent successful percutaneous coronary intervention.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. participate in any drug clinical trials within 3 months;&#xD;
&#xD;
          2. patients with life-threatening complications, or the researchers determined that the&#xD;
             survival time of patients with no more than 1 years;&#xD;
&#xD;
          3. serious neurological disease (Alzheimer's disease, Parkinson syndrome, progressive&#xD;
             lower limbs or deaf patients);&#xD;
&#xD;
          4. previous history of cancer or tumor, or pathological examination confirmed&#xD;
             precancerous lesions (such as breast ductal carcinoma in situ, or atypical hyperplasia&#xD;
             of the cervix);&#xD;
&#xD;
          5. patients refused to comply with the requirements of this study to complete the&#xD;
             research work.&#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>Dao Wen Wang, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>Tongji Hospital,Wuhan, Hubei, China, 430030</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tongji Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; Katus HA, Lindahl B, Morrow DA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S. Third universal definition of myocardial infarction. Circulation. 2012 Oct 16;126(16):2020-35. doi: 10.1161/CIR.0b013e31826e1058. Epub 2012 Aug 24. No abstract available.</citation>
    <PMID>22923432</PMID>
  </reference>
  <reference>
    <citation>Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.</citation>
    <PMID>21670242</PMID>
  </reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>November 25, 2021</last_update_submitted>
  <last_update_submitted_qc>November 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tongji Hospital</investigator_affiliation>
    <investigator_full_name>Dao Wen Wang</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <keyword>Ticagrelor</keyword>
  <keyword>Clopidogrel</keyword>
  <keyword>Acute Coronary Syndrome</keyword>
  <keyword>Percutaneous Coronary Intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- 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/NCT03239067
org study id: TJH-COSTIC
nct id: NCT03239067
lead sponsor: 
This is a prospective, single-center study to assess the long- and short-term outcomes of
      ticagrelor vs clopidogrel in Chinese patients with acute coronary syndrome undergoing
      percutaneous coronary intervention. Patients will undergo face-to-face interviews, phone
      calls, or/and chart reviews at 7 days, 1 month, 6 months and 12 months. When 4500 patients
      have completed the follow-up, an interim analysis will be performed.
observational model: Cohort
time perspective: Prospective
measure: Composite incidence of vascular death, myocardial infarction and stroke
time frame: up to 12 months
description: Vascular death was defined as death from cardiovascular causes or cerebrovascular causes and any unknown death unless there was another certain cause.
The definition of myocardial infarction was consistent with the Third Universal Definition of Myocardial Infarction (1).
Stroke was defined as a rapid onset of a new focal loss of neurologic function caused by an ischemic central nervous system event with residual symptoms lasting at least 24 hours from their onset or leading to death.
measure: Composite incidence of all-cause death, myocardial infarction and stroke
time frame: up to 12 months
description: All-cause death was defined as any death at hospital or after discharge.
The definition of myocardial infarction was consistent with the Third Universal Definition of Myocardial Infarction.
Stroke was defined as a rapid onset of a new focal loss of neurologic function caused by an ischemic central nervous system event with residual symptoms lasting at least 24 hours from their onset or leading to death.
measure: Composite incidence of vascular death, myocardial infarction, stroke, recurrent ischemia, transient ischemic attack, or other arterial thrombotic events
time frame: up to 12 months
description: Vascular death was defined as death from cardiovascular causes or cerebrovascular causes and any unknown death unless there was another certain cause.
The definition of myocardial infarction was consistent with the Third Universal Definition of Myocardial Infarction (1).
Stroke was defined as a rapid onset of a new focal loss of neurologic function caused by an ischemic central nervous system event with residual symptoms lasting at least 24 hours from their onset or leading to death.
measure: Incidence of safety endpoints
time frame: up to 12 months
description: Safety endpoints were defined according to the TIMI bleeding criteria.(2) Major bleeding (not related to heart surgery) was defined as fatal-, or intracranial bleeding including any clinically overt signs of hemorrhage associated with a decreased hemoglobin levels (≥5g/dl). Minor bleeding was defined as any clinically overt bleeding leading to decrease in hemoglobin levels of 3 to 5 g/dL or any bleeding requiring medical intervention. Minimal bleeding was defined as any overt bleeding event that did not meet the above criteria. An independent blinded central committee adjudicated all suspected endpoint event.
arm group label: ticagrelor group
description: patients prescribed with ticagrelor
arm group label: clopidogrel group
description: patients prescribed with clopidogrel
blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dao Wen Wang, Doctor
role: Study Chair
affiliation: Tongji Hospital,Wuhan, Hubei, China, 430030
facility: 
country: China
citation: Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; Katus HA, Lindahl B, Morrow DA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S. Third universal definition of myocardial infarction. Circulation. 2012 Oct 16;126(16):2020-35. doi: 10.1161/CIR.0b013e31826e1058. Epub 2012 Aug 24. No abstract available.
PMID: 22923432
citation: Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.
PMID: 21670242
responsible party type: Principal Investigator
investigator affiliation: Tongji Hospital
investigator full name: Dao Wen Wang
investigator title: Prof.
mesh term: Acute Coronary Syndrome
mesh term: Syndrome