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Treating Acute Pancreatitis With Dabigatran, a Pilot Study

Primary Purpose

Acute Pancreatitis

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Dabigatran Etexilate Mesylate

Standard of Care

About this trial

This is an interventional treatment trial for Acute Pancreatitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mayo clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Dabigatran Etexilate Mesylate

Standard of Care

Arm Description

Dabigatran 150mg BID for 3 days

Standard treatment for acute pancreatitis

Outcomes

Primary Outcome Measures

Adverse Events

Number of Reported Adverse Events

Secondary Outcome Measures

Full Information

NCT ID

NCT03807856

First Posted

January 15, 2019

Last Updated

August 30, 2022

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT03807856

Brief Title

Treating Acute Pancreatitis With Dabigatran, a Pilot Study

Official Title

Treating Acute Pancreatitis With Dabigatran, a Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Terminated

Why Stopped

Difficult recruitment

Study Start Date

June 24, 2019 (Actual)

Primary Completion Date

July 23, 2020 (Actual)

Study Completion Date

July 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Pancreatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dabigatran Etexilate Mesylate

Arm Type

Active Comparator

Arm Description

Dabigatran 150mg BID for 3 days

Arm Title

Standard of Care

Arm Type

Active Comparator

Arm Description

Standard treatment for acute pancreatitis

Intervention Type

Drug

Intervention Name(s)

Dabigatran Etexilate Mesylate

Other Intervention Name(s)

Pradaxa

Intervention Description

Dabigatran 150mg BID for 3 days

Intervention Type

Other

Intervention Name(s)

Standard of Care

Intervention Description

Daily vital signs, lab work and one outpatient clinic visit

Primary Outcome Measure Information:

Title

Adverse Events

Description

Number of Reported Adverse Events

Time Frame

One year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yan Bi, MD, PhD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo clinic

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

Treating Acute Pancreatitis With Dabigatran, a Pilot Study

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