xml: <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/NCT05973188</url>
    </required_header>
    <id_info>
      <org_study_id>IRC/23/09</org_study_id>
      <nct_id>NCT05973188</nct_id>
    </id_info>
    <brief_title>Safety and Efficacy of Rivaroxaban and Apixaban in Comparison to Warfarin in Left Ventricular Clot- Clinical Trial</brief_title>
    <acronym>WRAP</acronym>
    <official_title>Safety and Efficacy of Rivaroxaban and Apixaban in Comparison to Warfarin in Left Ventricular Clot- a Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peshawar Institute of Cardiology</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Getz Pharma</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Peshawar Institute of Cardiology</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The investigators aimed to design this randomized control trial to compare rivaroxaban and&#xD;
        apixaban with warfarin in Left ventricular thrombus resolution by&#xD;
  &#xD;
          -  Success rate of left ventricular thrombus resolution on follow up echocardiograms to be&#xD;
             done at 1st, 3rd and 6th months after starting on these drugs.&#xD;
  &#xD;
          -  Compare the adverse events of each drug in terms of major bleeding and stroke on follow&#xD;
             up.&#xD;
  &#xD;
        Left ventricular thrombus (LVT) leads to thromboembolism in about 10-15% cases. Currently,&#xD;
        guidelines recommended therapy for LVT is warfarin but treating LVT with warfarin is&#xD;
        challenging due to&#xD;
  &#xD;
          -  Its narrow therapeutic window.&#xD;
  &#xD;
          -  Drug-drug and drug-food interaction.&#xD;
  &#xD;
          -  Frequently tested International normalization ratio (INR) and cost effectiveness&#xD;
             especially in low to middle income countries.&#xD;
  &#xD;
        In contrast Rivaroxaban and Apixaban has no drug-food or major drug-drug interaction and&#xD;
        moreover it doesn't require frequent checks on INR and that's the reason Rivaroxaban and&#xD;
        apixaban use in LVT is gaining traction over time but there is paucity of data both&#xD;
        nationally and internationally. So further studies are required to evaluate the efficacy and&#xD;
        safety of rivaroxaban and apixaban in comparison to warfarin in LVT, especially in low to&#xD;
        middle income countries.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        1. TITLE:&#xD;
  &#xD;
             Safety and efficacy of Rivaroxaban and Apixaban in comparison to Warfarin in Left&#xD;
             ventricular clot- clinical trial&#xD;
  &#xD;
          2. INTRODUCTION:&#xD;
  &#xD;
             Left ventricular thrombus (LVT) is a known life threatening complication of myocardial&#xD;
             systolic dysfunction leading to thromboembolism in about 10-15% cases1. The incidence of&#xD;
             LVT has significantly decreased from 40% in pre-reperfusion era to 4% in reperfusion era&#xD;
             but still it's a significant number to treat and minimize mortality and morbidities2.3.&#xD;
             Up-to-date, guidelines recommended therapy for LVT is warfarin but due to its narrow&#xD;
             therapeutic window, drug-drug and drug-food interaction, its use is challenging and cost&#xD;
             effective, especially in low to middle income countries as it requires frequent checks&#xD;
             on INR (International normalization ratio). In contrast Rivaroxaban has no drug-food or&#xD;
             major drug-drug interaction and moreover it doesn't require frequent checks on INR and&#xD;
             that's the reason Rivaroxaban use in LVT is gaining traction over time but there is&#xD;
             paucity of data both nationally and internationally. Abdelnabi M et al. published the&#xD;
             first RCT (randomized control trial, No-LVT trial) on Egyptian population and concluded&#xD;
             that rivaroxaban is non inferior to warfarin in LVT but their sample was n=79 out of&#xD;
             which rivaroxaban arm had 39 patients only with a power of 80%. Alcalai R et al,4&#xD;
             studied and compared warfarin and Apixaban in LV-thrombus and concluded that Apixaban is&#xD;
             non inferior to warfarin in LV-thrombus but their sample size was very low to 17&#xD;
             patients in warfarin and 18 patients in apixaban group. So further studies are required&#xD;
             to evaluate the safety and efficacy of rivaroxaban and apixaban in LVT specially in low&#xD;
             to middle income countries where LVT management with warfarin is challenging because of&#xD;
             narrowed therapeutic window and frequently testing INR. The investigators aimed to&#xD;
             design this RCT to compare rivaroxaban and apixaban with warfarin in LVT in terms of&#xD;
             safety and efficacy.&#xD;
  &#xD;
          3. HYPOTHESIS:&#xD;
  &#xD;
        Direct acting oral anticoagulation (rivaroxaban and apixaban) is non inferior to warfarin in&#xD;
        LV thrombus resolution&#xD;
  &#xD;
        4. MATERIALS AND METHODS: 4a. Study Design: It will be a prospective, randomized, open-label,&#xD;
        parallel-group, noninferiority trial to evaluate the efficacy and safety of rivaroxaban and&#xD;
        apixaban versus warfarin in the treatment of LVT.&#xD;
  &#xD;
        4b. Study Settings: Peshawar Institute of Cardiology (PIC). 4c. Study Duration:&#xD;
  &#xD;
        1 year&#xD;
  &#xD;
        4d. Sample Size:&#xD;
  &#xD;
        Type: Binary Yes/No Type Variable (e.g. response vs no response) Design: Parallel Group&#xD;
        Objective: Non-inferiority&#xD;
  &#xD;
          -  Group 1 (Warfarin group): 48%&#xD;
  &#xD;
          -  Group 2 (Rivaroxaban group): 72%&#xD;
  &#xD;
          -  Group 3 (Apixaban group):&#xD;
  &#xD;
        Non-inferiority criteria: 10% Power Level (%): 95% Acceptable Drop out %: 10% N per Group: 42&#xD;
        (not taking into account drop out). N per Group: 47 (accounting for drop out). Total N: 141&#xD;
        subjects to be recruited.&#xD;
  &#xD;
        4e. Sampling Technique: Randomized and open label. The investigators will randomly assign&#xD;
        first patient into group A that is control group (warfarin group) then next patient to group&#xD;
        B (rivaroxaban group) and then next patient into group C (Apixaban group). The investigators&#xD;
        will repeat the cycle to achieve the target sample size in each group. Patients will be&#xD;
        randomized in group A, B and C in a ratio of 1:1:1, to either control group A (Warfarin group&#xD;
        with dose adjusted, target INR 2-3), group B (Rivaroxaban 20mg QD) and group C (Apixaban 5mg&#xD;
        BD (bis in die i.e. Twice a day) or 2.5mg BD if having two or more of the following, patients&#xD;
        with age ≥80years and/or creatinin≥1.5 and/or body weight ≤60kg). LVT resolution will be&#xD;
        assessed by blinded cardiologist via transthoracic echocardiogram at 1, 3 and 6 months'&#xD;
        interval after starting on the respective regimen.&#xD;
  &#xD;
        5. DATA COLLECTION PROCEDURE: On a preformed proforma.&#xD;
  &#xD;
        6. DATA ANALYSIS PROCEDURE: Stata version 14.2 will be used for data analysis. Frequencies&#xD;
        with percentages will be reported for categorical variables. Means with standard deviation&#xD;
        (depending on the normality assumption) or Median with Interquartile range (if the normality&#xD;
        assumption is not met). The chi2-Square test will be used to assess the statistical&#xD;
        significance for categorical variables (Fischer Exact test will be used if the expected cell&#xD;
        count is &gt;= 5). Independent Student t-test will be used to assess the statistical&#xD;
        significance of continuous variables.&#xD;
  &#xD;
        P-value ≤0.05 will be considered significant.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
    <phase>Phase 4</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>
      <intervention_model_description>Randomized and open label. We will randomly assign first patient into group A that is control group (warfarin group) then next patient to group B (rivaroxaban group) and then next patient into group C (Apixaban group). We will repeat the cycle to achieve the target sample size in each group. Patients will be randomized in group A, B and C in a ratio of 1:1:1, to either control group A (Warfarin group with dose adjusted, target INR 2-3), group B (Rivaroxaban 20mg QD) and group C (Apixaban 5mg BD or 2.5mg BD if having two or more of the following, patients with age ≥80years and/or creatinin≥1.5 and/or body weight ≤60kg). LVT resolution will be assessed by blinded cardiologist via transthoracic echocardiogram at 1, 3 and 6 months' interval after starting on the respective regimen.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Successful resolution of LV thrombus by Rivaroxaban and Apixaban in comparison to Warfarin</measure>
      <time_frame>Within 6months of randamization</time_frame>
      <description>Presence or absence of LV thrombus at one, three and six months follow up on echocardiogram.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time from start of drug to thrombus resolution in months</measure>
      <time_frame>Within 6 months of randomization</time_frame>
      <description>Secondary end point will be time in months after starting on drugs to LVT resolution (which will be assessed by follow up echocardiogram at one, three and six months duration)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>No of events of major bleeding (defined by International Society of Thrombosis and Hemostasis criteria)</measure>
      <time_frame>Within 6 months of randomization</time_frame>
      <description>Number of events of major bleedings (defined by International Society of Thrombosis and Hemostasis criteria as, (a) a fall in hemoglobin level of 2 g/dL or more or documented transfusion of at least 2 units of packed red blood cells, (b) involvement of a critical anatomical site (intracranial, spinal, ocular, pericardial, articular, intramuscular with compartment syndrome, retroperitoneal) in all three groups of patients after starting on drugs till resolution of thrombus and/or maximum 6 months follow up after start of therapy if failed to resolve thrombus.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>No of events of stroke (both ischemic and hemorrhagic)</measure>
      <time_frame>Within 6 months of randomization</time_frame>
      <description>No of events of stroke (both ischemic and hemorrhagic) in all three groups of patients after starting on drugs till resolution of thrombus and/or maximum 6 months follow up, after start of therapy if failed to resolve thrombus.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">141</enrollment>
    <condition>Left Ventricular Thrombus</condition>
    <arm_group>
      <arm_group_label>Group A, warfarin group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients started on warfarin, dose will be adjusted according to patient target INR (2-3)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B, Rivaroxaban (Xcept)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients started on rivaroxaban 20mg single dose in 24hours</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group C, Apixaban ( Apixaget)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients started on Apixaban 5mg or 2.5mg (12hours apart)</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Warfarin</intervention_name>
      <description>Anticoagulant</description>
      <arm_group_label>Group A, warfarin group</arm_group_label>
      <other_name>Warfarin oral tablet</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Rivaroxaban 20 MG Oral Tablet</intervention_name>
      <description>Anticoagulant</description>
      <arm_group_label>Group B, Rivaroxaban (Xcept)</arm_group_label>
      <other_name>Xcept</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Apixaban 5mg or 2.5mg oral tablet</intervention_name>
      <description>Anticoagulant</description>
      <arm_group_label>Group C, Apixaban ( Apixaget)</arm_group_label>
      <other_name>Apixaget</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria&#xD;
  &#xD;
            -  All hemodynamically stable patients with LV thrombus on echocardiogram after.&#xD;
  &#xD;
          Exclusion criteria&#xD;
  &#xD;
            -  Chronic Liver Disease (CLD) patients&#xD;
  &#xD;
            -  Creatinine clearance less than 15ml/min&#xD;
  &#xD;
            -  Recent Hemorrhagic stroke&#xD;
  &#xD;
            -  Thrombocytopenia, platelets &lt;50k or anemia with baseline HB &lt;9mg/dl&#xD;
  &#xD;
            -  Recent Major GI bleed&#xD;
  &#xD;
            -  History of atrial fibrillation and mitral stenosis&#xD;
  &#xD;
            -  History of deep vein thrombosis/pulmonary embolism and Patients already on&#xD;
               anticoagulation&#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>Ihsan Ullah, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peshawar Institute of Cardiology</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ihsan Ullah, MD</last_name>
      <phone>+923365948083</phone>
      <email>dr.ihsanulla@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ali Raza, MRCP</last_name>
      <phone>+923430978366</phone>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Peshawar Institute of Cardiology</name>
        <address>
          <city>Peshawar</city>
          <state>KPK</state>
          <zip>25000</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ihsan Ullah, MD</last_name>
        <phone>+923365949083</phone>
        <email>dr.ihsanulla@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Ali Raza, MBBS/MRCP</last_name>
        <phone>+447833250880</phone>
        <email>ali.raza@pic.edu.pk</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>May 8, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Peshawar Institute of Cardiology</investigator_affiliation>
      <investigator_full_name>Dr. Ihsan Ullah</investigator_full_name>
      <investigator_title>Doctor</investigator_title>
    </responsible_party>
    <keyword>Left ventricular thrombus, warfarin, rivaroxaban, apixaban</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>
      <mesh_term>Rivaroxaban</mesh_term>
      <mesh_term>Apixaban</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05973188
  org study id: IRC/23/09
  nct id: NCT05973188
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The investigators aimed to design this randomized control trial to compare rivaroxaban and
        apixaban with warfarin in Left ventricular thrombus resolution by
  
          -  Success rate of left ventricular thrombus resolution on follow up echocardiograms to be
             done at 1st, 3rd and 6th months after starting on these drugs.
  
          -  Compare the adverse events of each drug in terms of major bleeding and stroke on follow
             up.
  
        Left ventricular thrombus (LVT) leads to thromboembolism in about 10-15% cases. Currently,
        guidelines recommended therapy for LVT is warfarin but treating LVT with warfarin is
        challenging due to
  
          -  Its narrow therapeutic window.
  
          -  Drug-drug and drug-food interaction.
  
          -  Frequently tested International normalization ratio (INR) and cost effectiveness
             especially in low to middle income countries.
  
        In contrast Rivaroxaban and Apixaban has no drug-food or major drug-drug interaction and
        moreover it doesn't require frequent checks on INR and that's the reason Rivaroxaban and
        apixaban use in LVT is gaining traction over time but there is paucity of data both
        nationally and internationally. So further studies are required to evaluate the efficacy and
        safety of rivaroxaban and apixaban in comparison to warfarin in LVT, especially in low to
        middle income countries.
  1. TITLE:
  
             Safety and efficacy of Rivaroxaban and Apixaban in comparison to Warfarin in Left
             ventricular clot- clinical trial
  
          2. INTRODUCTION:
  
             Left ventricular thrombus (LVT) is a known life threatening complication of myocardial
             systolic dysfunction leading to thromboembolism in about 10-15% cases1. The incidence of
             LVT has significantly decreased from 40% in pre-reperfusion era to 4% in reperfusion era
             but still it's a significant number to treat and minimize mortality and morbidities2.3.
             Up-to-date, guidelines recommended therapy for LVT is warfarin but due to its narrow
             therapeutic window, drug-drug and drug-food interaction, its use is challenging and cost
             effective, especially in low to middle income countries as it requires frequent checks
             on INR (International normalization ratio). In contrast Rivaroxaban has no drug-food or
             major drug-drug interaction and moreover it doesn't require frequent checks on INR and
             that's the reason Rivaroxaban use in LVT is gaining traction over time but there is
             paucity of data both nationally and internationally. Abdelnabi M et al. published the
             first RCT (randomized control trial, No-LVT trial) on Egyptian population and concluded
             that rivaroxaban is non inferior to warfarin in LVT but their sample was n=79 out of
             which rivaroxaban arm had 39 patients only with a power of 80%. Alcalai R et al,4
             studied and compared warfarin and Apixaban in LV-thrombus and concluded that Apixaban is
             non inferior to warfarin in LV-thrombus but their sample size was very low to 17
             patients in warfarin and 18 patients in apixaban group. So further studies are required
             to evaluate the safety and efficacy of rivaroxaban and apixaban in LVT specially in low
             to middle income countries where LVT management with warfarin is challenging because of
             narrowed therapeutic window and frequently testing INR. The investigators aimed to
             design this RCT to compare rivaroxaban and apixaban with warfarin in LVT in terms of
             safety and efficacy.
  
          3. HYPOTHESIS:
  
        Direct acting oral anticoagulation (rivaroxaban and apixaban) is non inferior to warfarin in
        LV thrombus resolution
  
        4. MATERIALS AND METHODS: 4a. Study Design: It will be a prospective, randomized, open-label,
        parallel-group, noninferiority trial to evaluate the efficacy and safety of rivaroxaban and
        apixaban versus warfarin in the treatment of LVT.
  
        4b. Study Settings: Peshawar Institute of Cardiology (PIC). 4c. Study Duration:
  
        1 year
  
        4d. Sample Size:
  
        Type: Binary Yes/No Type Variable (e.g. response vs no response) Design: Parallel Group
        Objective: Non-inferiority
  
          -  Group 1 (Warfarin group): 48%
  
          -  Group 2 (Rivaroxaban group): 72%
  
          -  Group 3 (Apixaban group):
  
        Non-inferiority criteria: 10% Power Level (%): 95% Acceptable Drop out %: 10% N per Group: 42
        (not taking into account drop out). N per Group: 47 (accounting for drop out). Total N: 141
        subjects to be recruited.
  
        4e. Sampling Technique: Randomized and open label. The investigators will randomly assign
        first patient into group A that is control group (warfarin group) then next patient to group
        B (rivaroxaban group) and then next patient into group C (Apixaban group). The investigators
        will repeat the cycle to achieve the target sample size in each group. Patients will be
        randomized in group A, B and C in a ratio of 1:1:1, to either control group A (Warfarin group
        with dose adjusted, target INR 2-3), group B (Rivaroxaban 20mg QD) and group C (Apixaban 5mg
        BD (bis in die i.e. Twice a day) or 2.5mg BD if having two or more of the following, patients
        with age ≥80years and/or creatinin≥1.5 and/or body weight ≤60kg). LVT resolution will be
        assessed by blinded cardiologist via transthoracic echocardiogram at 1, 3 and 6 months'
        interval after starting on the respective regimen.
  
        5. DATA COLLECTION PROCEDURE: On a preformed proforma.
  
        6. DATA ANALYSIS PROCEDURE: Stata version 14.2 will be used for data analysis. Frequencies
        with percentages will be reported for categorical variables. Means with standard deviation
        (depending on the normality assumption) or Median with Interquartile range (if the normality
        assumption is not met). The chi2-Square test will be used to assess the statistical
        significance for categorical variables (Fischer Exact test will be used if the expected cell
        count is >= 5). Independent Student t-test will be used to assess the statistical
        significance of continuous variables.
  
        P-value ≤0.05 will be considered significant.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized and open label. We will randomly assign first patient into group A that is control group (warfarin group) then next patient to group B (rivaroxaban group) and then next patient into group C (Apixaban group). We will repeat the cycle to achieve the target sample size in each group. Patients will be randomized in group A, B and C in a ratio of 1:1:1, to either control group A (Warfarin group with dose adjusted, target INR 2-3), group B (Rivaroxaban 20mg QD) and group C (Apixaban 5mg BD or 2.5mg BD if having two or more of the following, patients with age ≥80years and/or creatinin≥1.5 and/or body weight ≤60kg). LVT resolution will be assessed by blinded cardiologist via transthoracic echocardiogram at 1, 3 and 6 months' interval after starting on the respective regimen.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Successful resolution of LV thrombus by Rivaroxaban and Apixaban in comparison to Warfarin
  time frame: Within 6months of randamization
  description: Presence or absence of LV thrombus at one, three and six months follow up on echocardiogram.
  measure: Time from start of drug to thrombus resolution in months
  time frame: Within 6 months of randomization
  description: Secondary end point will be time in months after starting on drugs to LVT resolution (which will be assessed by follow up echocardiogram at one, three and six months duration)
  measure: No of events of major bleeding (defined by International Society of Thrombosis and Hemostasis criteria)
  time frame: Within 6 months of randomization
  description: Number of events of major bleedings (defined by International Society of Thrombosis and Hemostasis criteria as, (a) a fall in hemoglobin level of 2 g/dL or more or documented transfusion of at least 2 units of packed red blood cells, (b) involvement of a critical anatomical site (intracranial, spinal, ocular, pericardial, articular, intramuscular with compartment syndrome, retroperitoneal) in all three groups of patients after starting on drugs till resolution of thrombus and/or maximum 6 months follow up after start of therapy if failed to resolve thrombus.
  measure: No of events of stroke (both ischemic and hemorrhagic)
  time frame: Within 6 months of randomization
  description: No of events of stroke (both ischemic and hemorrhagic) in all three groups of patients after starting on drugs till resolution of thrombus and/or maximum 6 months follow up, after start of therapy if failed to resolve thrombus.
  arm group label: Group A, warfarin group
  arm group type: Active Comparator
  description: Patients started on warfarin, dose will be adjusted according to patient target INR (2-3)
  arm group label: Group B, Rivaroxaban (Xcept)
  arm group type: Experimental
  description: Patients started on rivaroxaban 20mg single dose in 24hours
  arm group label: Group C, Apixaban ( Apixaget)
  arm group type: Experimental
  description: Patients started on Apixaban 5mg or 2.5mg (12hours apart)
  intervention type: Drug
  intervention name: Warfarin
  description: Anticoagulant
  arm group label: Group A, warfarin group
  other name: Warfarin oral tablet
  intervention type: Drug
  intervention name: Rivaroxaban 20 MG Oral Tablet
  description: Anticoagulant
  arm group label: Group B, Rivaroxaban (Xcept)
  other name: Xcept
  intervention type: Drug
  intervention name: Apixaban 5mg or 2.5mg oral tablet
  description: Anticoagulant
  arm group label: Group C, Apixaban ( Apixaget)
  other name: Apixaget
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ihsan Ullah, MD
  role: Principal Investigator
  affiliation: Peshawar Institute of Cardiology
  last name: Ihsan Ullah, MD
  phone: +923365948083
  email: dr.ihsanulla@gmail.com
  last name: Ali Raza, MRCP
  phone: +923430978366
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Pakistan
  responsible party type: Principal Investigator
  investigator affiliation: Peshawar Institute of Cardiology
  investigator full name: Dr. Ihsan Ullah
  investigator title: Doctor
  mesh term: Thrombosis
  mesh term: Warfarin
  mesh term: Rivaroxaban
  mesh term: Apixaban