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/NCT05975320</url>
    </required_header>
    <id_info>
      <org_study_id>Soh-med-23-07-03MS</org_study_id>
      <nct_id>NCT05975320</nct_id>
    </id_info>
    <brief_title>&quot;ORBIT&quot; Versus &quot;HAS-BLED&quot; Scores in Predicting Major Bleeding in Patients With Atrial Fibrillation Receiving Oral Anticoagulants.</brief_title>
    <official_title>&quot;ORBIT&quot; Versus &quot;HAS-BLED&quot; Scores in Predicting Major Bleeding in Patients With Atrial Fibrillation Receiving Oral Anticoagulants.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sohag University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sohag University</source>
    <oversight_info>
      <has_dmc>No</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>
        Atrial fibrillation (AF) is type of arrhythmia characterized by an irregular and often rapid&#xD;
        heartbeats, it has strong associations with other cardiovascular diseases, such as heart&#xD;
        failure, coronary artery disease (CAD), valvular heart disease, diabetes mellitus,&#xD;
        thyrotoxicosis and hypertension.&#xD;
  &#xD;
        Atrial fibrillation is the most frequent cardiac arrhythmia. It has been estimated that 6-12&#xD;
        million people worldwide will suffer this condition in the US by 2050 and 17.9 million people&#xD;
        in Europe by 2060. Atrial fibrillation is a major risk factor for ischemic stroke and&#xD;
        provokes important economic burden along with significant morbidity and mortality .&#xD;
  &#xD;
        (AF) is arrhythmia with the potential to cause thromboembolism. Studies suggest that AF&#xD;
        increases the risk of stroke five-folds. Stroke prevention is central to the management of&#xD;
        patients with atrial fibrillation (AF), and effective stroke prevention requires oral&#xD;
        anticoagulation (OAC). Either a vitamin K antagonist (VKA; e.g. warfarin) or a non-VKA oral&#xD;
        anticoagulant (NOAC) .&#xD;
  &#xD;
        It's essential reach the balance between prevention of thromboembolic as well as bleeding&#xD;
        events during the anticoagulant use.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">February 2024</completion_date>
    <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>incidence of bleeding events using both (HAS-BLED) &amp; (ORBIT) SCORES</measure>
      <time_frame>6 months</time_frame>
      <description>Patients receiving oral anticoagulants will be followed up for 6 months to detect occurrence of any major bleeding events include (spontaneous epistaxis , spontaneous bleeding per gums , hematemesis , bleeding per rectum , intracranial hemorrhage and internal hemorrhage ). Then, incidence of bleeding events using both (HAS-BLED) &amp; (ORBIT) SCORES will be calculated and compared for all cases .</description>
    </primary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Patients With Atrial Fibrillation Receiving Oral Anticoagulants</condition>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Warfarin</intervention_name>
      <description>Patients receiving oral anticoagulants will be followed up for 6 months to detect occurrence of any major bleeding events include (spontaneous epistaxis , spontaneous bleeding per gums , hematemesis , bleeding per rectum , intracranial hemorrhage and internal hemorrhage ). Then, incidence of bleeding events using both (HAS-BLED) &amp; (ORBIT) SCORES will be calculated and compared for all cases .</description>
      <other_name>apixaban, Rivarospire</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          -All patients with atrial fibrillation :&#xD;
  &#xD;
            1. Aged 18 years old or older .&#xD;
  &#xD;
            2. Underwent cardiac valve replacement&#xD;
  &#xD;
            3. Who have valvular heart disease receiving anticoagulants .&#xD;
  &#xD;
            4. Who have non valvular AF in whom CHA2DS 2VASc score 2 or more.&#xD;
  &#xD;
            5. Receiving either vitamin K antagonist e.g warfarin or NOAC .&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients with atrial fibrillation :&#xD;
  &#xD;
                 1. Aged 18 years old or older .&#xD;
  &#xD;
                 2. Underwent cardiac valve replacement&#xD;
  &#xD;
                 3. Who have valvular heart disease receiving anticoagulants .&#xD;
  &#xD;
                 4. Who have non valvular AF in whom CHA2DS 2VASc score 2 or more.&#xD;
  &#xD;
                 5. Receiving either vitamin K antagonist e.g warfarin or NOAC .&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients age less than 18 years old&#xD;
  &#xD;
            2. Patients receiving anticoagulants without atrial fibrillations&#xD;
  &#xD;
            3. Pregnant patients with AF&#xD;
  &#xD;
            4. Patients with AF on Non oral anticoagulants&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Yasmeen M Al-anwer, Resident</last_name>
      <phone>01152631299</phone>
      <email>yassminmohamed@med.sohag.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>lotfy H Abo Dahab, Professor</last_name>
      <phone>01003459739</phone>
    </overall_contact_backup>
    <reference>
      <citation>Piccini JP, Fraulo ES, Ansell JE, Fonarow GC, Gersh BJ, Go AS, Hylek EM, Kowey PR, Mahaffey KW, Thomas LE, Kong MH, Lopes RD, Mills RM, Peterson ED. Outcomes registry for better informed treatment of atrial fibrillation: rationale and design of ORBIT-AF. Am Heart J. 2011 Oct;162(4):606-612.e1. doi: 10.1016/j.ahj.2011.07.001.</citation>
      <PMID>21982650</PMID>
    </reference>
    <reference>
      <citation>Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest. 2010 Nov;138(5):1093-100. doi: 10.1378/chest.10-0134. Epub 2010 Mar 18.</citation>
      <PMID>20299623</PMID>
    </reference>
    <reference>
      <citation>De Caterina R, Husted S, Wallentin L, Andreotti F, Arnesen H, Bachmann F, Baigent C, Huber K, Jespersen J, Kristensen SD, Lip GY, Morais J, Rasmussen LH, Siegbahn A, Verheugt FW, Weitz JI. Vitamin K antagonists in heart disease: current status and perspectives (Section III). Position paper of the ESC Working Group on Thrombosis--Task Force on Anticoagulants in Heart Disease. Thromb Haemost. 2013 Dec;110(6):1087-107. doi: 10.1160/TH13-06-0443. Epub 2013 Nov 14.</citation>
      <PMID>24226379</PMID>
    </reference>
    <reference>
      <citation>O'Brien EC, Simon DN, Thomas LE, Hylek EM, Gersh BJ, Ansell JE, Kowey PR, Mahaffey KW, Chang P, Fonarow GC, Pencina MJ, Piccini JP, Peterson ED. The ORBIT bleeding score: a simple bedside score to assess bleeding risk in atrial fibrillation. Eur Heart J. 2015 Dec 7;36(46):3258-64. doi: 10.1093/eurheartj/ehv476. Epub 2015 Sep 29.</citation>
      <PMID>26424865</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sohag University</investigator_affiliation>
      <investigator_full_name>Yasmin Mohamed Mohamed</investigator_full_name>
      <investigator_title>resident of internal medicine department, Sohag university hospital</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Atrial Fibrillation</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Warfarin</mesh_term>
      <mesh_term>Apixaban</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05975320
  org study id: Soh-med-23-07-03MS
  nct id: NCT05975320
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Atrial fibrillation (AF) is type of arrhythmia characterized by an irregular and often rapid
        heartbeats, it has strong associations with other cardiovascular diseases, such as heart
        failure, coronary artery disease (CAD), valvular heart disease, diabetes mellitus,
        thyrotoxicosis and hypertension.
  
        Atrial fibrillation is the most frequent cardiac arrhythmia. It has been estimated that 6-12
        million people worldwide will suffer this condition in the US by 2050 and 17.9 million people
        in Europe by 2060. Atrial fibrillation is a major risk factor for ischemic stroke and
        provokes important economic burden along with significant morbidity and mortality .
  
        (AF) is arrhythmia with the potential to cause thromboembolism. Studies suggest that AF
        increases the risk of stroke five-folds. Stroke prevention is central to the management of
        patients with atrial fibrillation (AF), and effective stroke prevention requires oral
        anticoagulation (OAC). Either a vitamin K antagonist (VKA; e.g. warfarin) or a non-VKA oral
        anticoagulant (NOAC) .
  
        It's essential reach the balance between prevention of thromboembolic as well as bleeding
        events during the anticoagulant use.
  observational model: Case-Only
  time perspective: Prospective
  measure: incidence of bleeding events using both (HAS-BLED) & (ORBIT) SCORES
  time frame: 6 months
  description: Patients receiving oral anticoagulants will be followed up for 6 months to detect occurrence of any major bleeding events include (spontaneous epistaxis , spontaneous bleeding per gums , hematemesis , bleeding per rectum , intracranial hemorrhage and internal hemorrhage ). Then, incidence of bleeding events using both (HAS-BLED) & (ORBIT) SCORES will be calculated and compared for all cases .
  intervention type: Drug
  intervention name: Warfarin
  description: Patients receiving oral anticoagulants will be followed up for 6 months to detect occurrence of any major bleeding events include (spontaneous epistaxis , spontaneous bleeding per gums , hematemesis , bleeding per rectum , intracranial hemorrhage and internal hemorrhage ). Then, incidence of bleeding events using both (HAS-BLED) & (ORBIT) SCORES will be calculated and compared for all cases .
  other name: apixaban, Rivarospire
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Yasmeen M Al-anwer, Resident
  phone: 01152631299
  email: yassminmohamed@med.sohag.edu.eg
  last name: lotfy H Abo Dahab, Professor
  phone: 01003459739
  citation: Piccini JP, Fraulo ES, Ansell JE, Fonarow GC, Gersh BJ, Go AS, Hylek EM, Kowey PR, Mahaffey KW, Thomas LE, Kong MH, Lopes RD, Mills RM, Peterson ED. Outcomes registry for better informed treatment of atrial fibrillation: rationale and design of ORBIT-AF. Am Heart J. 2011 Oct;162(4):606-612.e1. doi: 10.1016/j.ahj.2011.07.001.
  PMID: 21982650
  citation: Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest. 2010 Nov;138(5):1093-100. doi: 10.1378/chest.10-0134. Epub 2010 Mar 18.
  PMID: 20299623
  citation: De Caterina R, Husted S, Wallentin L, Andreotti F, Arnesen H, Bachmann F, Baigent C, Huber K, Jespersen J, Kristensen SD, Lip GY, Morais J, Rasmussen LH, Siegbahn A, Verheugt FW, Weitz JI. Vitamin K antagonists in heart disease: current status and perspectives (Section III). Position paper of the ESC Working Group on Thrombosis--Task Force on Anticoagulants in Heart Disease. Thromb Haemost. 2013 Dec;110(6):1087-107. doi: 10.1160/TH13-06-0443. Epub 2013 Nov 14.
  PMID: 24226379
  citation: O'Brien EC, Simon DN, Thomas LE, Hylek EM, Gersh BJ, Ansell JE, Kowey PR, Mahaffey KW, Chang P, Fonarow GC, Pencina MJ, Piccini JP, Peterson ED. The ORBIT bleeding score: a simple bedside score to assess bleeding risk in atrial fibrillation. Eur Heart J. 2015 Dec 7;36(46):3258-64. doi: 10.1093/eurheartj/ehv476. Epub 2015 Sep 29.
  PMID: 26424865
  responsible party type: Principal Investigator
  investigator affiliation: Sohag University
  investigator full name: Yasmin Mohamed Mohamed
  investigator title: resident of internal medicine department, Sohag university hospital
  mesh term: Atrial Fibrillation
  mesh term: Warfarin
  mesh term: Apixaban
  sharing ipd: Undecided