Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2026-03-08 @ 3:30 AM
Study NCT ID:
NCT01588327
Status:
COMPLETED
Last Update Posted:
2012-04-30
First Post:
2012-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Pharmacodynamic Study of Dabigatran
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-27', 'studyFirstSubmitDate': '2012-04-26', 'studyFirstSubmitQcDate': '2012-04-27', 'lastUpdatePostDateStruct': {'date': '2012-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Blood Coagulation Tests']}, 'referencesModule': {'references': [{'pmid': '23718677', 'type': 'DERIVED', 'citation': 'Hawes EM, Deal AM, Funk-Adcock D, Gosselin R, Jeanneret C, Cook AM, Taylor JM, Whinna HC, Winkler AM, Moll S. Performance of coagulation tests in patients on therapeutic doses of dabigatran: a cross-sectional pharmacodynamic study based on peak and trough plasma levels. J Thromb Haemost. 2013 Aug;11(8):1493-502. doi: 10.1111/jth.12308.'}]}, 'descriptionModule': {'briefSummary': 'The ability to explain bleeding or clotting complications in patients treated with dabigatran remains challenging. In addition, there is limited data on how coagulation tests perform in patients treated with therapeutic doses of dabigatran. Predicted responses of coagulation tests to therapeutic doses of dabigatran may be helpful in better understanding abnormal responses to dabigatran. The purpose of the study is to define a therapeutic reference range for peak and trough coagulation tests in patients taking FDA approved doses of dabigatran and to determine which tests may be most clinically useful for monitoring dabigatran.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients taking FDA-approved doses of dabigatran and control subjects not taking an anticoagulant or antiplatelet were eligible for inclusion.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Medication therapy with dabigatran 75 mg twice daily or 150 mg twice daily for a minimum of 3 days\n\nExclusion Criteria:\n\n* CrCl \\< 15 ml/min\n* Non-FDA approved dose based on calculated CrCl with most recent SCr\n* Age \\< 18 years\n* Inability to communicate in the English language\n* Decisionally-impaired individuals\n* Incarcerated\n* Pregnant/Lactating (Pregnancy category: C, unevaluated effects in lactation)'}, 'identificationModule': {'nctId': 'NCT01588327', 'briefTitle': 'A Prospective Pharmacodynamic Study of Dabigatran', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'A Prospective Pharmacodynamic Study of Dabigatran Using Peak and Trough Coagulation Test Results in Patients on Therapeutic Doses of Dabigatran', 'orgStudyIdInfo': {'id': '11-1693'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental', 'description': 'Patient taking FDA approved dose of dabigatran'}, {'label': 'Control group', 'description': 'Person not taking any form of anticoagulation.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Emily Hawes, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}