<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/NCT03804125</url>
  </required_header>
  <id_info>
    <org_study_id>B0661097</org_study_id>
    <secondary_id>ELICUIS FV MEXICO</secondary_id>
    <nct_id>NCT03804125</nct_id>
  </id_info>
  <brief_title>A Study of Adverse Events and Suspected Adverse Drug Reactions in Patients Under Apixaban for Prevention of Stroke and Systemic Embolism With Non-Valvular Atrial Fibrillation and Venous Thromboembolic Events in Patients Who Have Undergone Elective Hip or Knee Replacement Surgery</brief_title>
  <official_title>A PHASE IV NON-INTERVENTIONAL STUDY. ADVERSE EVENTS (AES)/SUSPECTED ADVERSE DRUG REACTIONS (SADRS) ON THE PREVENTION OF STROKE AND SYSTEMIC EMBOLISM IN ADULT PATIENTS WITH NON-VALVULAR ATRIAL FIBRILLATION WITH ONE OR MORE RISK FACTORS AS PRIOR STOKE OR TRANSIENT ISCHAEMIC ATTACK; AGE &gt;75; HYPERTENSION; DIABETES MELLITUS; SYMPTOMATIC HEART FAILURE (NYHA CLASS &gt;II) AND PREVENTION OF VENOUS THROMBOEMBOLIC EVENTS (VTE) IN ADULT PATIENTS WHO HAVE UNDERGONE ELECTIVE HIP OR KNEE REPLACEMENT SURGERY UNDER TREATMENT WITH ELICUIS (REGISTERED) (APIXABAN)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <brief_summary>
    <textblock>
      To characterize and analyze the number, type and incidence of adverse events/suspected&#xD;
      adverse drug reactions in patients treated with Apixaban, according to therapeutic&#xD;
      indications approved in Mexico.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Company decision to not conduct the study and was cancelled prior to any enrollment.&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 1, 2021</start_date>
  <completion_date type="Anticipated">March 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>48 Months</target_duration>
  <primary_outcome>
    <measure>the number and type of suspected adverse drug reactions, including serious and non-serious cases</measure>
    <time_frame>48 months</time_frame>
    <description>To characterize and to analyze the number, type and incidence of suspected adverse drug reaction (SADRs) in patients receiving apixaban according to the therapeutic indications approved in Mexico:&#xD;
A. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors as prior stoke or transient ischaemic attack; age &gt;75; hypertension; diabetes mellitus; symptomatic heart failure (NYHA class &gt;II) B. and in prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery</description>
  </primary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Cerebral Stroke</condition>
  <condition>Thrombosis, Deep Vein</condition>
  <condition>Pulmonary Embolism</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients who have received at least one dose of apixaban for prevention stroke and&#xD;
        systemic embolism with non-valvular atrial fibrillation or for prevention of venous&#xD;
        thromboembolic events (VTE) in adult patients who have undergone elective hip or knee&#xD;
        replacement surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A signed and dated informed consent document indicating that the patient (or a legally&#xD;
             acceptable representative) has been informed of all pertinent aspects of the study.&#xD;
&#xD;
          -  Patients (men and women) over 18 years old.&#xD;
&#xD;
          -  Patients who have received at least one dose of apixaban for prevention of stroke and&#xD;
             systemic embolism with non-valvular atrial fibrillation with one or more of the&#xD;
             following stroke risk factors: prior stoke or transient ischaemic attack; age &gt;75;&#xD;
             hypertension; diabetes mellitus; symptomatic heart failure (NYHA class &gt;II); or for&#xD;
             prevention of venous thromboembolic events (VTE) in adult patients who have undergone&#xD;
             elective hip or knee replacement surgery.&#xD;
&#xD;
          -  Subjects who are willing and able to comply with all scheduled visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have received apixaban in a clinical trial.&#xD;
&#xD;
          -  Patients who received apixaban for another indication locally approved or have a&#xD;
             contraindication according to the information to prescribe of the product in Mexico.&#xD;
&#xD;
          -  Hypersensitivity to the active substance or to any of the excipients.&#xD;
&#xD;
          -  Active clinically significant bleeding.&#xD;
&#xD;
          -  Hepatic disease associated with coagulopathy and clinically relevant bleeding risk.&#xD;
&#xD;
          -  Lesion or condition considered a significant risk factor for major bleeding. This may&#xD;
             include current or recent gastrointestinal ulceration, presence of malignant neoplasms&#xD;
             at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or&#xD;
             ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal&#xD;
             varices, arteriovenous malformations, vascular aneurysms or major intraspinal or&#xD;
             intracerebral vascular abnormalities.&#xD;
&#xD;
          -  Concomitant treatment with any other anticoagulant agent e.g. unfractionated heparin&#xD;
             (UFH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin&#xD;
             derivatives (fondaparinux, etc.), and oral anticoagulants (warfarin, rivaroxaban,&#xD;
             dabigatran, etc.) except under specific circumstances of switching anticoagulant&#xD;
             therapy. Concomitant medication with Nonsteroidal anti-inflammatory drugs (NSAIDs ).&#xD;
&#xD;
          -  Pregnancy and breast-feeding.&#xD;
&#xD;
          -  Severe acute or chronic psychiatric condition and other significant medical condition.&#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>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>November 14, 2021</last_update_submitted>
  <last_update_submitted_qc>November 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Embolism</mesh_term>
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Embolism</mesh_term>
    <mesh_term>Thromboembolism</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
    <mesh_term>Drug-Related Side Effects and Adverse Reactions</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03804125
org study id: B0661097
secondary id: ELICUIS FV MEXICO
nct id: NCT03804125
lead sponsor: 
To characterize and analyze the number, type and incidence of adverse events/suspected
      adverse drug reactions in patients treated with Apixaban, according to therapeutic
      indications approved in Mexico.
observational model: Other
time perspective: Prospective
measure: the number and type of suspected adverse drug reactions, including serious and non-serious cases
time frame: 48 months
description: To characterize and to analyze the number, type and incidence of suspected adverse drug reaction (SADRs) in patients receiving apixaban according to the therapeutic indications approved in Mexico:
A. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors as prior stoke or transient ischaemic attack; age >75; hypertension; diabetes mellitus; symptomatic heart failure (NYHA class >II) B. and in prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
responsible party type: Sponsor
mesh term: Pulmonary Embolism
mesh term: Stroke
mesh term: Atrial Fibrillation
mesh term: Thrombosis
mesh term: Embolism
mesh term: Thromboembolism
mesh term: Venous Thrombosis
mesh term: Drug-Related Side Effects and Adverse Reactions
sharing ipd: No
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.