<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/NCT02982590</url>
  </required_header>
  <id_info>
    <org_study_id>304/PPSP/61313197</org_study_id>
    <nct_id>NCT02982590</nct_id>
  </id_info>
  <brief_title>Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus</brief_title>
  <official_title>Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus: A Prospective Randomized Outcome Blinded Study on the Size Reduction or Resolution of Left Ventricular Thrombus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universiti Sains Malaysia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut Jantung Negara</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universiti Sains Malaysia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the novel oral anticoagulant apixaban with the&#xD;
      standard therapy of warfarin on the size reduction or resolution of left ventricular thrombus&#xD;
      over 3 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Current treatment for left ventricular thrombus is anti-coagulant or blood thinning agent&#xD;
      known as warfarin. Recently at least three novel oral anticoagulant agents were used in the&#xD;
      treatment of atrial fibrillation, pulmonary embolism and deep vein thrombosis (DVT).&#xD;
&#xD;
      Novel oral anticoagulant drugs will require no blood taking for INR monitoring, hence less&#xD;
      visit and more convenience to patients. Latest studies also showed lesser rate of bleeding as&#xD;
      compared to warfarin and hence relatively safer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">November 2018</completion_date>
  <primary_completion_date type="Actual">November 2018</primary_completion_date>
  <phase>Phase 3</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Change in Left Ventricular Thrombus (LVT) Size</measure>
    <time_frame>3 months</time_frame>
    <description>Percentage of change in left ventricular thrombus (LVT) size after 12 weeks of Warfarin or Apixaban treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of Left Ventricular Thrombosis (LVT) by More Than 50%</measure>
    <time_frame>3 months</time_frame>
    <description>Percentage of participants who achieved left ventricular thrombus (LVT) reduction more than 50% in both Warfarin and Apixaban arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically Definite Cardiac Embolic Ischemic Stroke</measure>
    <time_frame>3 months</time_frame>
    <description>Number of participants who showed evidence of clinically definite cardiac embolic ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by CT scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Life Threatening Bleeding</measure>
    <time_frame>3 months</time_frame>
    <description>Number of participants who experienced life threatening bleeding attributed to the use of anti-coagulation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Left Ventricular Thrombosis</condition>
  <arm_group>
    <arm_group_label>warfarin sodium</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>warfarin daily, dosage according to INR monitor. Aim INR 2-3</description>
  </arm_group>
  <arm_group>
    <arm_group_label>apixaban</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Apixaban 5 MG Oral Tablet [ELIQUIS] will be given for randomly selected patients for 3 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apixaban 5 MG Oral Tablet [ELIQUIS]</intervention_name>
    <description>Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication.</description>
    <arm_group_label>apixaban</arm_group_label>
    <other_name>ELIQUIS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Warfarin Sodium</intervention_name>
    <description>as controlled arm since warfarin is the standard therapy for LV thrombus</description>
    <arm_group_label>warfarin sodium</arm_group_label>
    <other_name>Coumadin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 - 80 years old&#xD;
&#xD;
          2. Presence of LV thrombus or spontaneous echo contrast (SEC) grade 3 or 4 (Patel VG&#xD;
             1996), with regional wall motion abnormalities&#xD;
&#xD;
          3. HASBLED score less than 3&#xD;
&#xD;
          4. No episodes of major bleeding in the past 6 months a) Major bleeding defined as i.&#xD;
             episodes of bleeding with significant drop in haemoglobin(Hb)level of at least 2gm/dL&#xD;
             - Includes upper and lower gastrointestinal bleed ii. The need for blood transfusion&#xD;
             (pack cell) of at least 2 unit iii. Recent surgery with bleeding complications and&#xD;
             lost of Hb as in (i) or (ii) iv. Any intracranial bleeds with neurological deficits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient with unstable arrhythmias and/or recurrent cardiogenic shock&#xD;
&#xD;
          2. Patient with large ischemic stroke on recruitment-defined as involving &gt;1/3 of&#xD;
             cerebral hemisphere or deemed to have high chance of haemorrhagic transformation&#xD;
&#xD;
          3. Patient with permanent pacemaker&#xD;
&#xD;
          4. Patient who is post valve replacement therapy&#xD;
&#xD;
          5. Patient who is pregnant.&#xD;
&#xD;
          6. Patient with advanced kidney disease at stage V and not on dialysis (CrCl &lt;15 mL/min)&#xD;
&#xD;
          7. Patient with advanced liver disease with coagulopathy&#xD;
&#xD;
          8. Patient with organized and old left ventricular thrombus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr W. Yus Haniff W. Isa, M.MED</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universiti Sains Malaysia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universiti Sains Malaysia</name>
      <address>
        <city>Kota Bharu</city>
        <state>Kelanatan</state>
        <zip>16150</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <results_first_submitted>April 27, 2021</results_first_submitted>
  <results_first_submitted_qc>June 15, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 8, 2021</results_first_posted>
  <last_update_submitted>June 15, 2021</last_update_submitted>
  <last_update_submitted_qc>June 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universiti Sains Malaysia</investigator_affiliation>
    <investigator_full_name>Dr W. Yus Haniff W. Isa</investigator_full_name>
    <investigator_title>DR</investigator_title>
  </responsible_party>
  <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>
    <mesh_term>Apixaban</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 12, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT02982590/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Warfarin Sodium</title>
          <description>warfarin daily, dosage according to INR monitor. Aim INR 2-3&#xD;
Warfarin Sodium: as controlled arm since warfarin is the standard therapy for LV thrombus</description>
        </group>
        <group group_id="P2">
          <title>Apixaban</title>
          <description>Apixaban 5 MG Oral Tablet [ELIQUIS] will be given for randomly selected patients for 3 months.&#xD;
Apixaban 5 MG Oral Tablet [ELIQUIS]: Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Gender, Age, Co-morbidities, HAS-BLED score</population>
      <group_list>
        <group group_id="B1">
          <title>Warfarin Sodium</title>
          <description>warfarin daily, dosage according to INR monitor. Aim INR 2-3&#xD;
Warfarin Sodium: as controlled arm since warfarin is the standard therapy for LV thrombus</description>
        </group>
        <group group_id="B2">
          <title>Apixaban</title>
          <description>Apixaban 5 MG Oral Tablet [ELIQUIS] will be given for randomly selected patients for 3 months.&#xD;
Apixaban 5 MG Oral Tablet [ELIQUIS]: Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="13"/>
            <count group_id="B2" value="14"/>
            <count group_id="B3" value="27"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="13"/>
                    <count group_id="B2" value="14"/>
                    <count group_id="B3" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="13"/>
                    <count group_id="B2" value="14"/>
                    <count group_id="B3" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.00" spread="11.42"/>
                    <measurement group_id="B2" value="55.36" spread="11.04"/>
                    <measurement group_id="B3" value="55.19" spread="11.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="13"/>
                    <count group_id="B2" value="14"/>
                    <count group_id="B3" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Comorbidities</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Diabetes mellitus</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="13"/>
                    <count group_id="B2" value="14"/>
                    <count group_id="B3" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypertension</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="13"/>
                    <count group_id="B2" value="14"/>
                    <count group_id="B3" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ischemic heart disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="13"/>
                    <count group_id="B2" value="14"/>
                    <count group_id="B3" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Atrial fibrillation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="13"/>
                    <count group_id="B2" value="14"/>
                    <count group_id="B3" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chronic kidney disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="13"/>
                    <count group_id="B2" value="14"/>
                    <count group_id="B3" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyperlipidemia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="13"/>
                    <count group_id="B2" value="14"/>
                    <count group_id="B3" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HAS-BLED score</title>
          <description>Hypertension, Abnormal renal or liver function, Stroke, Bleeding, Labile INR, Elderly, Drugs or alcohol (HAS-BLED) score estimates the 1-year risk of major bleeding for patients on anticoagulation to assess risk-benefit in atrial fibrillation care. Minimum score = 0, maximum score = 9.&#xD;
Score of 0 to 1: Low risk for major bleeding. Score of 2: Moderate risk for major bleeding. Score ≥ 3: High risk for major bleeding.&#xD;
In our study, we exclude patients with HAS-BLED score &gt; 3. Thus, only patients with HAS-BLED score from 0 to 3 were recruited.</description>
          <units>total score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="13"/>
                    <count group_id="B2" value="14"/>
                    <count group_id="B3" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.46" spread="0.66"/>
                    <measurement group_id="B2" value="1.0" spread="0.68"/>
                    <measurement group_id="B3" value="1.22" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Change in Left Ventricular Thrombus (LVT) Size</title>
        <description>Percentage of change in left ventricular thrombus (LVT) size after 12 weeks of Warfarin or Apixaban treatment</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Warfarin Sodium</title>
            <description>Warfarin daily, dosage according to INR monitor. Aim INR 2-3&#xD;
Warfarin Sodium: as controlled arm since warfarin is the standard therapy for LV thrombus</description>
          </group>
          <group group_id="O2">
            <title>Apixaban</title>
            <description>Apixaban 5 MG Oral Tablet [ELIQUIS] will be given for randomly selected patients for 3 months.&#xD;
Apixaban 5 MG Oral Tablet [ELIQUIS]: Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Left Ventricular Thrombus (LVT) Size</title>
          <description>Percentage of change in left ventricular thrombus (LVT) size after 12 weeks of Warfarin or Apixaban treatment</description>
          <units>percentage of change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-61.45" spread="43.95"/>
                    <measurement group_id="O2" value="-65.08" spread="31.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of Left Ventricular Thrombosis (LVT) by More Than 50%</title>
        <description>Percentage of participants who achieved left ventricular thrombus (LVT) reduction more than 50% in both Warfarin and Apixaban arms.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Warfarin Sodium</title>
            <description>Warfarin daily, dosage according to INR monitor. Aim INR 2-3&#xD;
Warfarin Sodium: as controlled arm since warfarin is the standard therapy for LV thrombus</description>
          </group>
          <group group_id="O2">
            <title>Apixaban</title>
            <description>Apixaban 5 MG Oral Tablet [ELIQUIS] will be given for randomly selected patients for 3 months.&#xD;
Apixaban 5 MG Oral Tablet [ELIQUIS]: Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication.</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Left Ventricular Thrombosis (LVT) by More Than 50%</title>
          <description>Percentage of participants who achieved left ventricular thrombus (LVT) reduction more than 50% in both Warfarin and Apixaban arms.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.7"/>
                    <measurement group_id="O2" value="61.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinically Definite Cardiac Embolic Ischemic Stroke</title>
        <description>Number of participants who showed evidence of clinically definite cardiac embolic ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by CT scan</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Warfarin Sodium</title>
            <description>Warfarin daily, dosage according to INR monitor. Aim INR 2-3&#xD;
Warfarin Sodium: as controlled arm since warfarin is the standard therapy for LV thrombus</description>
          </group>
          <group group_id="O2">
            <title>Apixaban</title>
            <description>Apixaban 5 MG Oral Tablet [ELIQUIS] will be given for randomly selected patients for 3 months.&#xD;
Apixaban 5 MG Oral Tablet [ELIQUIS]: Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinically Definite Cardiac Embolic Ischemic Stroke</title>
          <description>Number of participants who showed evidence of clinically definite cardiac embolic ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by CT scan</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Life Threatening Bleeding</title>
        <description>Number of participants who experienced life threatening bleeding attributed to the use of anti-coagulation.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Warfarin Sodium</title>
            <description>Warfarin daily, dosage according to INR monitor. Aim INR 2-3&#xD;
Warfarin Sodium: as controlled arm since warfarin is the standard therapy for LV thrombus</description>
          </group>
          <group group_id="O2">
            <title>Apixaban</title>
            <description>Apixaban 5 MG Oral Tablet [ELIQUIS] will be given for randomly selected patients for 3 months.&#xD;
Apixaban 5 MG Oral Tablet [ELIQUIS]: Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication.</description>
          </group>
        </group_list>
        <measure>
          <title>Life Threatening Bleeding</title>
          <description>Number of participants who experienced life threatening bleeding attributed to the use of anti-coagulation.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Warfarin Sodium</title>
          <description>Warfarin daily, dosage according to INR monitor. Aim INR 2-3&#xD;
Warfarin Sodium: as controlled arm since warfarin is the standard therapy for LV thrombus</description>
        </group>
        <group group_id="E2">
          <title>Apixaban</title>
          <description>Apixaban 5 MG Oral Tablet [ELIQUIS] will be given for randomly selected patients for 3 months.&#xD;
Apixaban 5 MG Oral Tablet [ELIQUIS]: Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <description>Worsening heart failure. Died in hospital.</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Sudden Death at home</sub_title>
                <description>Family informed patient died suddenly at home.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal bleeding and Death</sub_title>
                <description>Admitted for upper GI bleeding with coagulopathy. Later develop worsening heart failure and died in hospital.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Ischemic Stroke with hemorrhagic transformation and death</sub_title>
                <description>Patient develop stroke after off Apixaban 48 hours following end of study. Complicated with hemorrhagic transformation and death.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Sample size of the study was small due to the pilot nature of the study, being a single-center strict study and strict exclusion criteria.&#xD;
High rate of early angioplasty in this center also contributed to the low number of patients with left ventricle thrombus (LVT).&#xD;
Many patients with LVT were excluded because of their ill clinical condition on presentation, deranged renal/liver functions on diagnosis, organized or old LVT and other logistic issues.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>DR W YUS HANIFF W ISA</name_or_title>
      <organization>HOSPITAL UNIVERSITI SAINS MALAYSIA</organization>
      <phone>09-767 3000</phone>
      <email>wyhaniff@usm.my</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02982590
org study id: 304/PPSP/61313197
nct id: NCT02982590
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to compare the novel oral anticoagulant apixaban with the
      standard therapy of warfarin on the size reduction or resolution of left ventricular thrombus
      over 3 months.
Current treatment for left ventricular thrombus is anti-coagulant or blood thinning agent
      known as warfarin. Recently at least three novel oral anticoagulant agents were used in the
      treatment of atrial fibrillation, pulmonary embolism and deep vein thrombosis (DVT).

      Novel oral anticoagulant drugs will require no blood taking for INR monitoring, hence less
      visit and more convenience to patients. Latest studies also showed lesser rate of bleeding as
      compared to warfarin and hence relatively safer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Percent Change in Left Ventricular Thrombus (LVT) Size
time frame: 3 months
description: Percentage of change in left ventricular thrombus (LVT) size after 12 weeks of Warfarin or Apixaban treatment
measure: Change of Left Ventricular Thrombosis (LVT) by More Than 50%
time frame: 3 months
description: Percentage of participants who achieved left ventricular thrombus (LVT) reduction more than 50% in both Warfarin and Apixaban arms.
measure: Clinically Definite Cardiac Embolic Ischemic Stroke
time frame: 3 months
description: Number of participants who showed evidence of clinically definite cardiac embolic ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by CT scan
measure: Life Threatening Bleeding
time frame: 3 months
description: Number of participants who experienced life threatening bleeding attributed to the use of anti-coagulation.
arm group label: warfarin sodium
arm group type: Active Comparator
description: warfarin daily, dosage according to INR monitor. Aim INR 2-3
arm group label: apixaban
arm group type: Experimental
description: Apixaban 5 MG Oral Tablet [ELIQUIS] will be given for randomly selected patients for 3 months.
intervention type: Drug
intervention name: Apixaban 5 MG Oral Tablet [ELIQUIS]
description: Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication.
arm group label: apixaban
other name: ELIQUIS
intervention type: Drug
intervention name: Warfarin Sodium
description: as controlled arm since warfarin is the standard therapy for LV thrombus
arm group label: warfarin sodium
other name: Coumadin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Dr W. Yus Haniff W. Isa, M.MED
role: Principal Investigator
affiliation: Universiti Sains Malaysia
facility: 
country: Malaysia
responsible party type: Principal Investigator
investigator affiliation: Universiti Sains Malaysia
investigator full name: Dr W. Yus Haniff W. Isa
investigator title: DR
mesh term: Thrombosis
mesh term: Warfarin
mesh term: Apixaban
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Sample size of the study was small due to the pilot nature of the study, being a single-center strict study and strict exclusion criteria.
High rate of early angioplasty in this center also contributed to the low number of patients with left ventricle thrombus (LVT).
Many patients with LVT were excluded because of their ill clinical condition on presentation, deranged renal/liver functions on diagnosis, organized or old LVT and other logistic issues.
point of contact: 