<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/NCT03280641</url>
  </required_header>
  <id_info>
    <org_study_id>2015-P-016</org_study_id>
    <nct_id>NCT03280641</nct_id>
  </id_info>
  <brief_title>D-dimer In Patients With atRial Fibrillation rEceiving antiCoagulation Therapy</brief_title>
  <acronym>DIRECT</acronym>
  <official_title>The Role of D-dimer in Patients With Atrial Fibrillation Receiving Anticoagulation Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wuhan Asia Heart Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wuhan Asia Heart 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a sigle-center, prospective study to evaluate the role of D-Dimer testing in patients&#xD;
      with atrial fibrillation receiving Dabigatran or warfarin anticoagulation therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with atrial fibrillation receiving Dabigatran or warfarin anticoagulation therapy&#xD;
      was screened and signed to two group: Dabigatran group and Warfarin group. D-dimer test was&#xD;
      analyzed before and 3 months after anticoagulation starting specificly. Patients were&#xD;
      followed-up for at least 12 months,and clinical outcomes, including thrombotic events major&#xD;
      bleeding events and all-cause deaths were recorded during follow-up period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 9, 2015</start_date>
  <completion_date type="Actual">September 1, 2017</completion_date>
  <primary_completion_date type="Actual">July 30, 2017</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>Cardiovascular events</measure>
    <time_frame>12 months</time_frame>
    <description>Thrombotic events, cardiovascular deaths, major bleeding events</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1194</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Strokes Thrombotic</condition>
  <arm_group>
    <arm_group_label>Dabigatran Group</arm_group_label>
    <description>Patiets with atrial fibrillation received dabigatran (110mg, bid).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Warfarin Group</arm_group_label>
    <description>Patiets with atrial fibrillation received warfarin (110mg, bid).The target international normalized ratio (INR):1.6-3.0</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dabigatran Etexilate 110mg</intervention_name>
    <description>Dabigatran Etexilate 110mg, BID</description>
    <arm_group_label>Dabigatran Group</arm_group_label>
    <other_name>Pradaxa</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Warfarin Sodium</intervention_name>
    <description>Target INR:1.6-3.0</description>
    <arm_group_label>Warfarin Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Non-valvular atrial fibrillation receiving Dabigatran or warfarin&#xD;
        anticoagulation therapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-valvular atrial fibrillation&#xD;
&#xD;
          -  Receiving oral anticoagulation therapy and have good compliance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Life expectancy less than 1 year&#xD;
&#xD;
          -  Thrombosis or major bleeding history within 3 months&#xD;
&#xD;
          -  Refusal to Participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Litao ZHANG, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wuhan Asia Heart Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>WAHH</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 10, 2017</study_first_submitted>
  <study_first_submitted_qc>September 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 10, 2017</last_update_submitted>
  <last_update_submitted_qc>September 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombotic Stroke</mesh_term>
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Warfarin</mesh_term>
    <mesh_term>Dabigatran</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>We will share the IPD after the paper being published</ipd_description>
  </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/NCT03280641
org study id: 2015-P-016
nct id: NCT03280641
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a sigle-center, prospective study to evaluate the role of D-Dimer testing in patients
      with atrial fibrillation receiving Dabigatran or warfarin anticoagulation therapy.
Patients with atrial fibrillation receiving Dabigatran or warfarin anticoagulation therapy
      was screened and signed to two group: Dabigatran group and Warfarin group. D-dimer test was
      analyzed before and 3 months after anticoagulation starting specificly. Patients were
      followed-up for at least 12 months,and clinical outcomes, including thrombotic events major
      bleeding events and all-cause deaths were recorded during follow-up period.
observational model: Cohort
time perspective: Prospective
measure: Cardiovascular events
time frame: 12 months
description: Thrombotic events, cardiovascular deaths, major bleeding events
arm group label: Dabigatran Group
description: Patiets with atrial fibrillation received dabigatran (110mg, bid).
arm group label: Warfarin Group
description: Patiets with atrial fibrillation received warfarin (110mg, bid).The target international normalized ratio (INR):1.6-3.0
intervention type: Drug
intervention name: Dabigatran Etexilate 110mg
description: Dabigatran Etexilate 110mg, BID
arm group label: Dabigatran Group
other name: Pradaxa
intervention type: Drug
intervention name: Warfarin Sodium
description: Target INR:1.6-3.0
arm group label: Warfarin Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
last name: Litao ZHANG, MD
role: Principal Investigator
affiliation: Wuhan Asia Heart Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Thrombotic Stroke
mesh term: Atrial Fibrillation
mesh term: Warfarin
mesh term: Dabigatran
sharing ipd: Undecided
ipd description: We will share the IPD after the paper being published