Treating Acute Pancreatitis With Dabigatran, a Pilot Study

NCT03807856 | Terminated Phase 1 FDA Drug

• 1 other identifier: 18-004345
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Number of Reported Adverse Events

  One year

Study Arms (2)

Dabigatran Etexilate Mesylate

ACTIVE COMPARATOR

Dabigatran 150mg BID for 3 days

Drug: Dabigatran Etexilate Mesylate; Other: Standard of Care

Standard of Care

ACTIVE COMPARATOR

Standard treatment for acute pancreatitis

Other: Standard of Care

Interventions

Dabigatran Etexilate Mesylate DRUG

Dabigatran 150mg BID for 3 days

Also known as: Pradaxa

Dabigatran Etexilate Mesylate

Standard of Care OTHER

Daily vital signs, lab work and one outpatient clinic visit

Dabigatran Etexilate Mesylate; Standard of Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute Pancreatitis (presence at least two of three features: typical pain, amylase or lipase \>3 times UNL and AP on images)
• years old
• Willingness to sign the informed consent
• Symptom onset within 72 hours

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo clinic

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pancreatitis

Interventions

Dabigatran; Standard of Care

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Yan Bi, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 17, 2019
• Study Start: June 24, 2019
• Primary Completion: July 23, 2020
• Study Completion: July 23, 2020
• Last Updated: September 1, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)