Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT01138969
Status:
COMPLETED
Last Update Posted:
2015-09-09
First Post:
2010-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy of Proton Pump Inhibitor in Prevention of Clopidogrel-related Peptic Ulcer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010437', 'term': 'Peptic Ulcer'}], 'ancestors': [{'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}, {'id': 'D000077144', 'term': 'Clopidogrel'}], 'ancestors': [{'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pihsu@isca.vghks.gov.tw', 'phone': '886-7-3462121', 'title': 'Dr. Ping-I Hsu', 'phoneExt': '8233', 'organization': 'KaohsiungVGH'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The patients without symptoms who refused follow-up endoscopy were regarded as having no recurrent ulcers. Because peptic ulcer may be asymptomatic, the cumulative number of recurrent peptic ulcer might be underestimated in both groups.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Esomeprazole Plus Clopidogrel Group', 'description': 'esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months', 'otherNumAtRisk': 83, 'otherNumAffected': 1, 'seriousNumAtRisk': 83, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Clopidogrel Group', 'description': 'clopidogrel 75 mg qd for 6 months', 'otherNumAtRisk': 82, 'otherNumAffected': 1, 'seriousNumAtRisk': 82, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'unstable angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'thrombotic events'}], 'seriousEvents': [{'term': 'acute myocardial infarct', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'thrombotic events'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Recurrent Peptic Ulcer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esomeprazole Plus Clopidogrel Group', 'description': 'esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months'}, {'id': 'OG001', 'title': 'Clopidogrel Group', 'description': 'clopidogrel 75 mg qd for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Number of participants with recurrent peptic ulcer within 6 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Peptic Ulcer Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esomeprazole Plus Clopidogrel Group', 'description': 'esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months'}, {'id': 'OG001', 'title': 'Clopidogrel Group', 'description': 'clopidogrel 75 mg qd for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'participants with peptic ulcer bleeding within 6 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Esomeprazole Plus Clopidogrel Group', 'description': 'esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months'}, {'id': 'FG001', 'title': 'Clopidogrel Group', 'description': 'clopidogrel 75 mg qd for 6 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '82'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '82'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '1. Dates of the recruitment period: From August 2008 to August 2012\n2. Type of location: Kaohsiung Veterans General Hospital', 'preAssignmentDetails': 'None were excluded following participant enrollment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Esomeprazole Plus Clopidogrel Group', 'description': 'esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months'}, {'id': 'BG001', 'title': 'Clopidogrel Group', 'description': 'clopidogrel 75 mg qd for 6 months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.6', 'spread': '11.5', 'groupId': 'BG000'}, {'value': '73.3', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '72.0', 'spread': '11.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-06', 'studyFirstSubmitDate': '2010-06-07', 'resultsFirstSubmitDate': '2012-12-31', 'studyFirstSubmitQcDate': '2010-06-07', 'lastUpdatePostDateStruct': {'date': '2015-09-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-12-31', 'studyFirstPostDateStruct': {'date': '2010-06-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrent Peptic Ulcer', 'timeFrame': '6 months', 'description': 'Number of participants with recurrent peptic ulcer within 6 months'}], 'secondaryOutcomes': [{'measure': 'Peptic Ulcer Bleeding', 'timeFrame': '6 months', 'description': 'participants with peptic ulcer bleeding within 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['proton pump inhibitor', 'peptic ulcer', 'clopidogrel', 'prevention'], 'conditions': ['Peptic Ulcer']}, 'referencesModule': {'references': [{'pmid': '21144850', 'type': 'DERIVED', 'citation': 'Hsu PI, Lai KH, Liu CP. Esomeprazole with clopidogrel reduces peptic ulcer recurrence, compared with clopidogrel alone, in patients with atherosclerosis. Gastroenterology. 2011 Mar;140(3):791-8. doi: 10.1053/j.gastro.2010.11.056. Epub 2010 Dec 7.'}]}, 'descriptionModule': {'briefSummary': 'Proton Pump Inhibitors (PPI) can prevent the recurrence of peptic ulcer in clopidogrel users.', 'detailedDescription': 'The aim of the prospective, randomized study is to investigate the efficacy of PPI in prevention of ulcer recurrence for clopidogrel users. We plan to enroll 300 clopidogrel users without baseline gastroduodenal ulcer at initial endoscopy. The patients will be randomly assigned to receive either (1) esomeprazole (20 mg qd) plus clopidogrel or (2) clopidogrel treatment alone for 6 months. The ulcer recurrence rate between the treatment groups will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* We plan to enroll 300 clopidogrel users without baseline gastroduodenal ulcer at initial endoscopy. The patients will be randomly assigned to receive either (1) esomeprazole (20 mg qd) plus clopidogrel or (2) clopidogrel treatment alone for 6 months.\n\nExclusion Criteria:\n\n* 1.serious disease 2.refuse informed consent'}, 'identificationModule': {'nctId': 'NCT01138969', 'briefTitle': 'Efficacy of Proton Pump Inhibitor in Prevention of Clopidogrel-related Peptic Ulcer', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Veterans General Hospital.'}, 'officialTitle': 'Efficacy of Proton Pump Inhibitor in Prevention of Clopidogrel-related Peptic Ulcer and Gastrointestinal Bleeding', 'orgStudyIdInfo': {'id': 'VGHKS98-CT6-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Esomeprazole plus clopidogrel group', 'description': 'esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months', 'interventionNames': ['Drug: esomeprazole']}, {'type': 'NO_INTERVENTION', 'label': 'Clopidogrel group', 'description': 'clopidogrel 75 mg qd for 6 months'}], 'interventions': [{'name': 'esomeprazole', 'type': 'DRUG', 'otherNames': ['plavix'], 'description': 'esomeprazole 20 mg qd for 6 months', 'armGroupLabels': ['Esomeprazole plus clopidogrel group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '813', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Veterans General Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'Kwok-Hung Lai, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kaohsiung Veterans General Hospital.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Veterans General Hospital.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Gastroenterology Division', 'investigatorFullName': 'Ping-I (William) Hsu, M.D.', 'investigatorAffiliation': 'Kaohsiung Veterans General Hospital.'}}}}