Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-01-04 @ 4:23 PM
Study NCT ID:
NCT03807856
Status:
TERMINATED
Last Update Posted:
2022-09-01
First Post:
2019-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treating Acute Pancreatitis With Dabigatran, a Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069604', 'term': 'Dabigatran'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Difficult recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-30', 'studyFirstSubmitDate': '2019-01-15', 'studyFirstSubmitQcDate': '2019-01-15', 'lastUpdatePostDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'One year', 'description': 'Number of Reported Adverse Events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Pancreatitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Researchers are studying the safety and efficacy of Dabigatran in the treatment of acute pancreatitis.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute Pancreatitis (presence at least two of three features: typical pain, amylase or lipase \\>3 times UNL and AP on images)\n* 18-75 years old\n* Willingness to sign the informed consent\n* Symptom onset within 72 hours\n\nExclusion Criteria:\n\n* Under 18 years of age or over 75 years of age\n* Pregnancy or lactating\n* Presence of pseudo aneurysm on CT\n* Predicted severe acute pancreatitis\n* Unwilling or unable to sign the informed consent\n* Had recent surgery or sphincterotomy\n* Active pathological bleeding\n* Concurrent use of anti-coagulation\n* Known serious hypersensitivity reaction to Dabigatran\n* CrCI \\<30mL/min or on dialysis\n* Mechanical prosthetic valves\n* Liver disease\n* Cancer\n* On Chemotherapy or immunosuppressant\n* Persistent ALT, AST, Akl Phos \\>2 x ULN\n* Active hepatitis C, active hepatitis B, and active hepatitis A\n* Anemia (hemoglobin \\<10g/dL)\n* Thrombocytopenia\n* Concomitant use of P-gp inhibitors'}, 'identificationModule': {'nctId': 'NCT03807856', 'briefTitle': 'Treating Acute Pancreatitis With Dabigatran, a Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Treating Acute Pancreatitis With Dabigatran, a Pilot Study', 'orgStudyIdInfo': {'id': '18-004345'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dabigatran Etexilate Mesylate', 'description': 'Dabigatran 150mg BID for 3 days', 'interventionNames': ['Drug: Dabigatran Etexilate Mesylate', 'Other: Standard of Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Standard treatment for acute pancreatitis', 'interventionNames': ['Other: Standard of Care']}], 'interventions': [{'name': 'Dabigatran Etexilate Mesylate', 'type': 'DRUG', 'otherNames': ['Pradaxa'], 'description': 'Dabigatran 150mg BID for 3 days', 'armGroupLabels': ['Dabigatran Etexilate Mesylate']}, {'name': 'Standard of Care', 'type': 'OTHER', 'description': 'Daily vital signs, lab work and one outpatient clinic visit', 'armGroupLabels': ['Dabigatran Etexilate Mesylate', 'Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Yan Bi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yan Bi', 'investigatorAffiliation': 'Mayo Clinic'}}}}