Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-29 @ 6:53 PM
Study NCT ID:
NCT01647568
Status:
COMPLETED
Last Update Posted:
2012-07-23
First Post:
2012-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Continuing Anti-platelet Agents During Colonoscopic Polypectomy: A Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 715}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'lastUpdateSubmitDate': '2012-07-19', 'studyFirstSubmitDate': '2012-07-19', 'studyFirstSubmitQcDate': '2012-07-19', 'lastUpdatePostDateStruct': {'date': '2012-07-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Post-polypectomy Bleeding', 'Anti-platelet Therapy', 'Colonoscopy']}, 'referencesModule': {'references': [{'pmid': '23403011', 'type': 'DERIVED', 'citation': 'Feagins LA, Iqbal R, Harford WV, Halai A, Cryer BL, Dunbar KB, Davila RE, Spechler SJ. Low rate of postpolypectomy bleeding among patients who continue thienopyridine therapy during colonoscopy. Clin Gastroenterol Hepatol. 2013 Oct;11(10):1325-32. doi: 10.1016/j.cgh.2013.02.003. Epub 2013 Feb 9.'}]}, 'descriptionModule': {'briefSummary': 'At our VA hospital, in general, it is the policy of our GI lab to not stop our patients anti-platelet therapy whenever they see us for a routine colonoscopy. We do this because we believe the risk of stopping these sort of medications outweigh the risks of a complication from a colonoscopy.\n\nTherefore, we are enrolling patients who are either on clopidogrel or prasugrel or not on any anti-platelet/anti-coagulant therapy that come to our GI lab routine colonoscopies. We perform the procedure just like we normally would and then follow-up with the patient 7 and 30 days after their procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting to the GI lab for elective colonoscopy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients presenting to the GI lab for elective colonoscopy\n\nExclusion Criteria:\n\n* Patients on Coumadin or other anti-coagulants\n* Patients with Inflammatory Bowel Disease'}, 'identificationModule': {'nctId': 'NCT01647568', 'briefTitle': 'Safety of Continuing Anti-platelet Agents During Colonoscopic Polypectomy: A Prospective Study', 'organization': {'class': 'FED', 'fullName': 'Dallas VA Medical Center'}, 'orgStudyIdInfo': {'id': 'DVAMC-09-084'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'Patients who are not on any anti-platelet/anti-coagulant therapy and present to our lab for a elective colonoscopy.'}, {'label': 'Thienopyridine Users', 'description': 'Patients on Clopidogrel or prasugrel when they present for an elective colonoscopy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas VA Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dallas VA Medical Center', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Gastroenterologist', 'investigatorFullName': 'Linda A Feagins', 'investigatorAffiliation': 'Dallas VA Medical Center'}}}}