<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/NCT02240953</url>
  </required_header>
  <id_info>
    <org_study_id>KOSUYOLU2</org_study_id>
    <nct_id>NCT02240953</nct_id>
  </id_info>
  <brief_title>Anticoagulation Regiments in Patients With Prosthetic Heart Valve Thrombosis</brief_title>
  <official_title>Comparison of Different Anticoagulation Regiments in Patients With Prosthetic Heart Valve Non-ObstructiveThrombosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prosthetic valve thrombosis is a serious complication with high mortality and morbidity.&#xD;
      However, the best anticoagulant treatment strategies for patients with prosthetic heart valve&#xD;
      thrombosis have not been fully known. In this study the investigators wanted to identify the&#xD;
      most effective and safe regimen among different anticoagulant regimens.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Three different anticoagulant treatment regimens for patients with prosthetic heart valve&#xD;
      non-obstructive thrombosis have been described. Patients are included in each group randomly.&#xD;
      In the first arm only warfarin is given to the patients with a target INR level of 2.5-4. In&#xD;
      the second arm 100 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment&#xD;
      in combination with warfarin. In the third arm 300 mg acetylsalicylic acid and a proton pump&#xD;
      inhibitor are added to treatment in ombination with warfarin. Also there is an observational&#xD;
      follow-up group of patients who do not have prosthetic heart valve thrombosis. These patients&#xD;
      also are followed under only warfarin therapy with INR level of 2.5-4 . All patients are&#xD;
      followed by serial transesophageal echocardiography performed every 6 months. Follow-up&#xD;
      period is at least 6 months (range 6-60 months). Informed consent is taken from all patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2009</start_date>
  <completion_date type="Anticipated">March 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2014</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>Decreased thrombus size</measure>
    <time_frame>6 months</time_frame>
    <description>Decreased thrombus size on control transesophageal echocardiography in the absence of fatal and non fatal major complications</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Same thrombus size</measure>
    <time_frame>6 months</time_frame>
    <description>Thrombus size remains as similar as the previous transesophageal echocardiographic examination findings in the absence of any fatal and non fatal major complications</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Increased thrombus size</measure>
    <time_frame>6 months</time_frame>
    <description>Increased thrombus size on control transesophageal echocardiography in the absence of fatal and non fatal major complications</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complications</measure>
    <time_frame>6 months</time_frame>
    <description>Nonfatal major complication: Ischemic stroke, intracranial hemorrhage, embolism (coronary or peripheral), bleeding requiring transfusion&#xD;
Nonfatal minor complication: Bleeding without need for transfusion, TIA.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Thrombosis</condition>
  <arm_group>
    <arm_group_label>Warfarin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the first arm only warfarin is given with a target INR level of 2.5-4 to the patients with prosthetic heart valve thrombosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Warfarin + ASA 100 mg + PPI</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the second arm 100 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin for the patients with prosthetic heart valve thrombosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Warfarin + ASA 300 mg + PPI</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the third arm 300 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin for the patients with prosthetic heart valve thrombosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observational Warfarin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm is an observational group of patients who do not have prosthetic heart valve thrombosis. These patients also are followed under only warfarin therapy with INR level of 2.5-4.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Warfarin</intervention_name>
    <description>Only warfarin is given with a target INR level of 2.5-4 to the patients with prosthetic heart valve thrombosis</description>
    <arm_group_label>Warfarin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Warfarin + ASA 100 mg + PPI</intervention_name>
    <description>100 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin for the patients with prosthetic heart valve thrombosis</description>
    <arm_group_label>Warfarin + ASA 100 mg + PPI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Warfarin + ASA 300 mg + PPI</intervention_name>
    <description>In the third arm 300 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin for the patients with prosthetic heart valve thrombosis</description>
    <arm_group_label>Warfarin + ASA 300 mg + PPI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Observational Warfarin</intervention_name>
    <description>This is an observational group of patients who do not have prosthetic heart valve thrombosis. These patients also are followed under only warfarin therapy with INR level of 2.5-4.</description>
    <arm_group_label>Observational Warfarin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with prosthetic heart valve thrombosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kosuyolu Kartal Heart Training and Research Hospital</name>
      <address>
        <city>İstanbul</city>
        <zip>34844</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mehmet Özkan, Prof</last_name>
      <phone>905322551512</phone>
      <email>memoozkan1@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Mehmet Özkan, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>September 15, 2014</last_update_submitted>
  <last_update_submitted_qc>September 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>MEHMET OZKAN</investigator_full_name>
    <investigator_title>Principal Investigator, MD., Prof., Head of Cardiology</investigator_title>
  </responsible_party>
  <keyword>Anticoagulation</keyword>
  <keyword>Prosthetic Heart Valves</keyword>
  <keyword>Acetylsalicylic acid</keyword>
  <keyword>Warfarin</keyword>
  <keyword>Thrombosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Warfarin</mesh_term>
  </intervention_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/NCT02240953
org study id: KOSUYOLU2
nct id: NCT02240953
lead sponsor: 
has dmc: No
Prosthetic valve thrombosis is a serious complication with high mortality and morbidity.
      However, the best anticoagulant treatment strategies for patients with prosthetic heart valve
      thrombosis have not been fully known. In this study the investigators wanted to identify the
      most effective and safe regimen among different anticoagulant regimens.
Three different anticoagulant treatment regimens for patients with prosthetic heart valve
      non-obstructive thrombosis have been described. Patients are included in each group randomly.
      In the first arm only warfarin is given to the patients with a target INR level of 2.5-4. In
      the second arm 100 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment
      in combination with warfarin. In the third arm 300 mg acetylsalicylic acid and a proton pump
      inhibitor are added to treatment in ombination with warfarin. Also there is an observational
      follow-up group of patients who do not have prosthetic heart valve thrombosis. These patients
      also are followed under only warfarin therapy with INR level of 2.5-4 . All patients are
      followed by serial transesophageal echocardiography performed every 6 months. Follow-up
      period is at least 6 months (range 6-60 months). Informed consent is taken from all patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Decreased thrombus size
time frame: 6 months
description: Decreased thrombus size on control transesophageal echocardiography in the absence of fatal and non fatal major complications
measure: Same thrombus size
time frame: 6 months
description: Thrombus size remains as similar as the previous transesophageal echocardiographic examination findings in the absence of any fatal and non fatal major complications
measure: Increased thrombus size
time frame: 6 months
description: Increased thrombus size on control transesophageal echocardiography in the absence of fatal and non fatal major complications
measure: Complications
time frame: 6 months
description: Nonfatal major complication: Ischemic stroke, intracranial hemorrhage, embolism (coronary or peripheral), bleeding requiring transfusion
Nonfatal minor complication: Bleeding without need for transfusion, TIA.
arm group label: Warfarin
arm group type: Active Comparator
description: In the first arm only warfarin is given with a target INR level of 2.5-4 to the patients with prosthetic heart valve thrombosis
arm group label: Warfarin + ASA 100 mg + PPI
arm group type: Active Comparator
description: In the second arm 100 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin for the patients with prosthetic heart valve thrombosis
arm group label: Warfarin + ASA 300 mg + PPI
arm group type: Active Comparator
description: In the third arm 300 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin for the patients with prosthetic heart valve thrombosis
arm group label: Observational Warfarin
arm group type: Active Comparator
description: This arm is an observational group of patients who do not have prosthetic heart valve thrombosis. These patients also are followed under only warfarin therapy with INR level of 2.5-4.
intervention type: Drug
intervention name: Warfarin
description: Only warfarin is given with a target INR level of 2.5-4 to the patients with prosthetic heart valve thrombosis
arm group label: Warfarin
intervention type: Drug
intervention name: Warfarin + ASA 100 mg + PPI
description: 100 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin for the patients with prosthetic heart valve thrombosis
arm group label: Warfarin + ASA 100 mg + PPI
intervention type: Drug
intervention name: Warfarin + ASA 300 mg + PPI
description: In the third arm 300 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin for the patients with prosthetic heart valve thrombosis
arm group label: Warfarin + ASA 300 mg + PPI
intervention type: Drug
intervention name: Observational Warfarin
description: This is an observational group of patients who do not have prosthetic heart valve thrombosis. These patients also are followed under only warfarin therapy with INR level of 2.5-4.
arm group label: Observational Warfarin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
investigator full name: MEHMET OZKAN
investigator title: Principal Investigator, MD., Prof., Head of Cardiology
mesh term: Thrombosis
mesh term: Warfarin