<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/NCT03264937</url>
  </required_header>
  <id_info>
    <org_study_id>2017-P-033</org_study_id>
    <nct_id>NCT03264937</nct_id>
  </id_info>
  <brief_title>Social-software iMproving wARfarin Therapy</brief_title>
  <acronym>SMART</acronym>
  <official_title>Randomized Evaluation of Social-software Improving Warfarin Therapy in Patients With Mechanical Heart Valve Replacement</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>
      Poor anticoagulation quality is a major problem among Chinese patients receiving warfarin&#xD;
      therapy in traditional health care settings. Improving warfarin therapy has been crucial for&#xD;
      Chinese patients. Wechat is social-software in China. Most of all Chinese adults use Wechat,&#xD;
      as well as our patients. So we set up a Wechat-based mini-program to instruct Chinese&#xD;
      patients' warfarin therapy. We aim to assess whether social software could improve warfarin&#xD;
      therapy in Chinese patients by conducting a single-centre, open-label, prospective,&#xD;
      randomized clinical trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Social software is becoming a necessary of life. Wechat, powered by Tencent company, is the&#xD;
      most popular social software in China. People can chat with others no matter how far away&#xD;
      from each other.&#xD;
&#xD;
      Anticoagulation Quality is very important for patients receiving warfarin anticoagulation&#xD;
      therapy, which is usually evaluated Time in therapeutic range (TTR). It is reported that TTR&#xD;
      is very low (38.8%) in China patients. So we are planning to introduce the social software to&#xD;
      set up a bridge for clinicians and their patients, to instruct warfarin therapy. We aim to&#xD;
      investigate whether social software could be used to improve warfarin anticoagulation quality&#xD;
      of Chinese patients.&#xD;
&#xD;
      We planned to enrol enough eligible patients receiving warfarin therapy due to the mechanical&#xD;
      valves in a randomized controlled trial. Warfarin-treated patients were assigned to social&#xD;
      software management group ( in which warfarin therapy was guided via the social platform by&#xD;
      experienced clinicians) or to the traditional management control group (in which warfarin&#xD;
      therapy was managed with traditional model). The primary outcomes the first time to bleeding&#xD;
      or thrombotic events, the secondary outcomes were an elevation in time in therapeutic range&#xD;
      (TTR) of international normalized ratio (INR), reduction in INR variation and number of&#xD;
      extremely high INR results during 18 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">March 8, 2019</completion_date>
  <primary_completion_date type="Actual">March 1, 2019</primary_completion_date>
  <phase>N/A</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to First Event</measure>
    <time_frame>Up to 18 months</time_frame>
    <description>Thrombotic events, such as Valve thrombosis, Stroke, Peripheral embolism; Major bleeding, such as cerebral hemorrhage，gastrointestinal bleeding etc.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time in therapeutic range</measure>
    <time_frame>Up to 18 months</time_frame>
    <description>Time in target range (TTR) based on Prothrombin Time standardized to the International Normalized Ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Individual variation of International Normalized Ratio (INR)</measure>
    <time_frame>Up to 18 months</time_frame>
    <description>Standard deviation (SD) of individual INR results</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Times of extremely high International Normalized Ratio (INR) values</measure>
    <time_frame>Up to 18 months</time_frame>
    <description>Times of INR results above 4.0; Times of INR results above 12.0</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">735</enrollment>
  <condition>Anticoagulants Causing Adverse Effects in Therapeutic Use</condition>
  <condition>Patient Compliance</condition>
  <arm_group>
    <arm_group_label>Social-software management group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>We set up a mini-program based on wechat application. We instruct warfarin therapy via social-software including dose adjustment, answer questions, remind monitoring INR et.al.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine management group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This is the control group, Warfarin therapy was managed via traditional style without social software intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Social-software management</intervention_name>
    <description>Using Wechat application, a social platform, to manage warfarin therapy in patients with mechanical valve replacement.</description>
    <arm_group_label>Social-software management group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Received mechanical valve replacement;&#xD;
&#xD;
          -  Receiving warfarin anticoagulation therapy;&#xD;
&#xD;
          -  Have smartphone and Know how to use wechat application and our mini-program;&#xD;
&#xD;
          -  be expected to survive for the duration of the study;&#xD;
&#xD;
          -  not be suffering from intracranial bleeding (intracranial haemorrhage, subarachnoid&#xD;
             haemorrhage, hemorrhagic stroke) or any other contraindication described in the&#xD;
             warfarin package insert;&#xD;
&#xD;
          -  be willing to be randomized;&#xD;
&#xD;
          -  sign the informed consent form;&#xD;
&#xD;
          -  not be enrolled in another randomized clinical trial that involves a drug or device&#xD;
             intervention.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subject has had an intracranial haemorrhage, subarachnoid haemorrhage, hemorrhagic&#xD;
             stroke, or any other absolute/major contraindication described in the warfarin package&#xD;
             insert within the last month&#xD;
&#xD;
          -  subject enrolled in another randomized clinical trial that involves a drug or device&#xD;
             intervention&#xD;
&#xD;
          -  subject is not able to follow the protocol and all related instructions and does not&#xD;
             have a caregiver with these skills&#xD;
&#xD;
          -  Patients were considered being not suitable for this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhenlu Zhang, MD,PhD</last_name>
    <role>Study Director</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>June 2019</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>June 17, 2019</last_update_submitted>
  <last_update_submitted_qc>June 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wuhan Asia Heart Hospital</investigator_affiliation>
    <investigator_full_name>Litao Zhang, MD</investigator_full_name>
    <investigator_title>Manager of anticoagulation clinic</investigator_title>
  </responsible_party>
  <keyword>TTR</keyword>
  <keyword>INR</keyword>
  <keyword>Warfarin</keyword>
  <keyword>social software</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We are going to make individual participant data (IPD) available to other researchers after our paper published</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
  </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/NCT03264937
org study id: 2017-P-033
nct id: NCT03264937
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Poor anticoagulation quality is a major problem among Chinese patients receiving warfarin
      therapy in traditional health care settings. Improving warfarin therapy has been crucial for
      Chinese patients. Wechat is social-software in China. Most of all Chinese adults use Wechat,
      as well as our patients. So we set up a Wechat-based mini-program to instruct Chinese
      patients' warfarin therapy. We aim to assess whether social software could improve warfarin
      therapy in Chinese patients by conducting a single-centre, open-label, prospective,
      randomized clinical trial.
Social software is becoming a necessary of life. Wechat, powered by Tencent company, is the
      most popular social software in China. People can chat with others no matter how far away
      from each other.

      Anticoagulation Quality is very important for patients receiving warfarin anticoagulation
      therapy, which is usually evaluated Time in therapeutic range (TTR). It is reported that TTR
      is very low (38.8%) in China patients. So we are planning to introduce the social software to
      set up a bridge for clinicians and their patients, to instruct warfarin therapy. We aim to
      investigate whether social software could be used to improve warfarin anticoagulation quality
      of Chinese patients.

      We planned to enrol enough eligible patients receiving warfarin therapy due to the mechanical
      valves in a randomized controlled trial. Warfarin-treated patients were assigned to social
      software management group ( in which warfarin therapy was guided via the social platform by
      experienced clinicians) or to the traditional management control group (in which warfarin
      therapy was managed with traditional model). The primary outcomes the first time to bleeding
      or thrombotic events, the secondary outcomes were an elevation in time in therapeutic range
      (TTR) of international normalized ratio (INR), reduction in INR variation and number of
      extremely high INR results during 18 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time to First Event
time frame: Up to 18 months
description: Thrombotic events, such as Valve thrombosis, Stroke, Peripheral embolism; Major bleeding, such as cerebral hemorrhage，gastrointestinal bleeding etc.
measure: Time in therapeutic range
time frame: Up to 18 months
description: Time in target range (TTR) based on Prothrombin Time standardized to the International Normalized Ratio
measure: Individual variation of International Normalized Ratio (INR)
time frame: Up to 18 months
description: Standard deviation (SD) of individual INR results
measure: Times of extremely high International Normalized Ratio (INR) values
time frame: Up to 18 months
description: Times of INR results above 4.0; Times of INR results above 12.0
arm group label: Social-software management group
arm group type: Experimental
description: We set up a mini-program based on wechat application. We instruct warfarin therapy via social-software including dose adjustment, answer questions, remind monitoring INR et.al.
arm group label: Routine management group
arm group type: No Intervention
description: This is the control group, Warfarin therapy was managed via traditional style without social software intervention.
intervention type: Behavioral
intervention name: Social-software management
description: Using Wechat application, a social platform, to manage warfarin therapy in patients with mechanical valve replacement.
arm group label: Social-software management group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Zhenlu Zhang, MD,PhD
role: Study Director
affiliation: Wuhan Asia Heart Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Wuhan Asia Heart Hospital
investigator full name: Litao Zhang, MD
investigator title: Manager of anticoagulation clinic
sharing ipd: Yes
ipd description: We are going to make individual participant data (IPD) available to other researchers after our paper published
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)