Treating Acute Pancreatitis With Dabigatran, a Pilot Study

Phase 1

Terminated

• Conditions: Acute Pancreatitis
• Interventions: Drug: Dabigatran Etexilate Mesylate; Other: Standard of Care

• Registration Number: NCT03807856
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2019-01-15
• Study First Submitted QC: 2019-01-15
• Study First Posted: 2019-01-17
• Study Start: 2019-06-24
• Primary Completion: 2020-07-23
• Study Completion: 2020-07-23
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-30
• Last Update Posted: 2022-09-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dabigatran Etexilate Mesylate	Standard of Care	Dabigatran 150mg BID for 3 days
Dabigatran Etexilate Mesylate	Dabigatran Etexilate Mesylate	Dabigatran 150mg BID for 3 days
Standard of Care	Standard of Care	Standard treatment for acute pancreatitis

Primary Outcome Measures

Name	Time	Method
Adverse Events	One year	Number of Reported Adverse Events

Trial Locations

Locations (1)

Mayo clinic; 🇺🇸 Jacksonville, Florida, United States