<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/NCT03807856</url>
  </required_header>
  <id_info>
    <org_study_id>18-004345</org_study_id>
    <nct_id>NCT03807856</nct_id>
  </id_info>
  <brief_title>Treating Acute Pancreatitis With Dabigatran, a Pilot Study</brief_title>
  <official_title>Treating Acute Pancreatitis With Dabigatran, a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Researchers are studying the safety and efficacy of Dabigatran in the treatment of acute&#xD;
      pancreatitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects with acute pancreatitis who meet the inclusion and exclusion criteria for the study&#xD;
      will be recruited. Subjects will be randomized to receive either Dabigatran 150mg daily for&#xD;
      three days or standard treatment. Vital signs, CBC, inflammatory markers and BMP, and&#xD;
      bleeding complications will be evaluated daily for the next 7 days of until discharge&#xD;
      whichever is sooner.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Difficult recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">June 24, 2019</start_date>
  <completion_date type="Actual">July 23, 2020</completion_date>
  <primary_completion_date type="Actual">July 23, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>One year</time_frame>
    <description>Number of Reported Adverse Events</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Acute Pancreatitis</condition>
  <arm_group>
    <arm_group_label>Dabigatran Etexilate Mesylate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dabigatran 150mg BID for 3 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard treatment for acute pancreatitis</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dabigatran Etexilate Mesylate</intervention_name>
    <description>Dabigatran 150mg BID for 3 days</description>
    <arm_group_label>Dabigatran Etexilate Mesylate</arm_group_label>
    <other_name>Pradaxa</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Daily vital signs, lab work and one outpatient clinic visit</description>
    <arm_group_label>Dabigatran Etexilate Mesylate</arm_group_label>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute Pancreatitis (presence at least two of three features: typical pain, amylase or&#xD;
             lipase &gt;3 times UNL and AP on images)&#xD;
&#xD;
          -  18-75 years old&#xD;
&#xD;
          -  Willingness to sign the informed consent&#xD;
&#xD;
          -  Symptom onset within 72 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 years of age or over 75 years of age&#xD;
&#xD;
          -  Pregnancy or lactating&#xD;
&#xD;
          -  Presence of pseudo aneurysm on CT&#xD;
&#xD;
          -  Predicted severe acute pancreatitis&#xD;
&#xD;
          -  Unwilling or unable to sign the informed consent&#xD;
&#xD;
          -  Had recent surgery or sphincterotomy&#xD;
&#xD;
          -  Active pathological bleeding&#xD;
&#xD;
          -  Concurrent use of anti-coagulation&#xD;
&#xD;
          -  Known serious hypersensitivity reaction to Dabigatran&#xD;
&#xD;
          -  CrCI &lt;30mL/min or on dialysis&#xD;
&#xD;
          -  Mechanical prosthetic valves&#xD;
&#xD;
          -  Liver disease&#xD;
&#xD;
          -  Cancer&#xD;
&#xD;
          -  On Chemotherapy or immunosuppressant&#xD;
&#xD;
          -  Persistent ALT, AST, Akl Phos &gt;2 x ULN&#xD;
&#xD;
          -  Active hepatitis C, active hepatitis B, and active hepatitis A&#xD;
&#xD;
          -  Anemia (hemoglobin &lt;10g/dL)&#xD;
&#xD;
          -  Thrombocytopenia&#xD;
&#xD;
          -  Concomitant use of P-gp inhibitors&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yan Bi, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo clinic</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>August 30, 2022</last_update_submitted>
  <last_update_submitted_qc>August 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Yan Bi</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dabigatran</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03807856
org study id: 18-004345
nct id: NCT03807856
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Researchers are studying the safety and efficacy of Dabigatran in the treatment of acute
      pancreatitis.
Subjects with acute pancreatitis who meet the inclusion and exclusion criteria for the study
      will be recruited. Subjects will be randomized to receive either Dabigatran 150mg daily for
      three days or standard treatment. Vital signs, CBC, inflammatory markers and BMP, and
      bleeding complications will be evaluated daily for the next 7 days of until discharge
      whichever is sooner.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse Events
time frame: One year
description: Number of Reported Adverse Events
arm group label: Dabigatran Etexilate Mesylate
arm group type: Active Comparator
description: Dabigatran 150mg BID for 3 days
arm group label: Standard of Care
arm group type: Active Comparator
description: Standard treatment for acute pancreatitis
intervention type: Drug
intervention name: Dabigatran Etexilate Mesylate
description: Dabigatran 150mg BID for 3 days
arm group label: Dabigatran Etexilate Mesylate
other name: Pradaxa
intervention type: Other
intervention name: Standard of Care
description: Daily vital signs, lab work and one outpatient clinic visit
arm group label: Dabigatran Etexilate Mesylate
arm group label: Standard of Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yan Bi, MD, PhD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Yan Bi
investigator title: Principal Investigator
mesh term: Pancreatitis
mesh term: Dabigatran
sharing ipd: No