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Treating Acute Pancreatitis With Dabigatran, a Pilot Study

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT03807856
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
38.2
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Researchers are studying the safety and efficacy of Dabigatran in the treatment of acute pancreatitis.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dabigatran Etexilate Mesylate
  • Other: Standard of Care
 Phase 1

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treating Acute Pancreatitis With Dabigatran, a Pilot Study
Actual Study Start Date :
Jun 24, 2019
Anticipated Primary Completion Date :
Jul 28, 2022
Anticipated Study Completion Date :
Aug 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Dabigatran Etexilate Mesylate

Dabigatran 150mg BID for 3 days

Drug: Dabigatran Etexilate Mesylate
Dabigatran 150mg BID for 3 days
Other Names:
  • Pradaxa

    • Other: Standard of Care
    Daily vital signs, lab work and one outpatient clinic visit
    Active Comparator: Standard of Care

    Standard treatment for acute pancreatitis

    Other: Standard of Care
    Daily vital signs, lab work and one outpatient clinic visit

    Outcome Measures

    Primary Outcome Measures

    1. Adverse Events [One year]

      Number of Reported Adverse Events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Acute Pancreatitis (presence at least two of three features: typical pain, amylase or lipase >3 times UNL and AP on images)

    • 18-75 years old

    • Willingness to sign the informed consent

    • Symptom onset within 72 hours

    Exclusion Criteria:

    • Under 18 years of age or over 75 years of age

    • Pregnancy or lactating

    • Presence of pseudo aneurysm on CT

    • Predicted severe acute pancreatitis

    • Unwilling or unable to sign the informed consent

    • Had recent surgery or sphincterotomy

    • Active pathological bleeding

    • Concurrent use of anti-coagulation

    • Known serious hypersensitivity reaction to Dabigatran

    • CrCI <30mL/min or on dialysis

    • Mechanical prosthetic valves

    • Liver disease

    • Cancer

    • On Chemotherapy or immunosuppressant

    • Persistent ALT, AST, Akl Phos >2 x ULN

    • Active hepatitis C, active hepatitis B, and active hepatitis A

    • Anemia (hemoglobin <10g/dL)

    • Thrombocytopenia

    • Concomitant use of P-gp inhibitors

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo clinic Jacksonville Florida United States 32224

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Yan Bi, MD, PhD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Yan Bi, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT03807856
    Other Study ID Numbers:
    • 18-004345
    First Posted:
    Jan 17, 2019
    Last Update Posted:
    Apr 1, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pancreatitis
    Dabigatran

    Study Results

    No Results Posted as of Apr 1, 2022