Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 5:04 AM
Study NCT ID:
NCT01106534
Status:
COMPLETED
Last Update Posted:
2023-11-14
First Post:
2010-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D023921', 'term': 'Coronary Stenosis'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D023903', 'term': 'Coronary Restenosis'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D000077144', 'term': 'Clopidogrel'}, {'id': 'D000068799', 'term': 'Prasugrel Hydrochloride'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010879', 'term': 'Piperazines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.rutledge@av.abbott.com', 'phone': '(408) 845-3820', 'title': 'David R Rutledge', 'organization': 'Abbott Vascular'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The participants enrolled in this study will be followed by Abbott Vacular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the outcomes.'}}, 'adverseEventsModule': {'timeFrame': '5 years', 'description': 'Adverse events were not be reported here as the participants enrolled in this study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.', 'eventGroups': [{'id': 'EG000', 'title': 'Second Enrollment Phase of XIENCE V® USA', 'description': 'The participants enrolled in this study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Composite of All Death, MI and Stroke (Defined as MACE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '12 Month DAPT Arm', 'description': 'placebo + aspirin\n\nplacebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.'}, {'id': 'OG001', 'title': '30 Month DAPT Arm', 'description': 'clopidogrel + aspirin OR prasugrel + aspirin\n\nclopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.'}], 'timeFrame': '12-33 months post-stent', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.'}, {'type': 'PRIMARY', 'title': 'Incidence of ARC Definite or Probable ST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '12 Month DAPT Arm', 'description': 'placebo + aspirin\n\nplacebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.'}, {'id': 'OG001', 'title': '30 Month DAPT Arm', 'description': 'clopidogrel + aspirin OR prasugrel + aspirin\n\nclopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.'}], 'timeFrame': '12-33 months post-stent', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.'}, {'type': 'PRIMARY', 'title': 'Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '12 Month DAPT Arm', 'description': 'placebo + aspirin\n\nplacebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.'}, {'id': 'OG001', 'title': '30 Month DAPT Arm', 'description': 'clopidogrel + aspirin OR prasugrel + aspirin\n\nclopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.'}], 'timeFrame': '12-33 months post-stent', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.'}, {'type': 'SECONDARY', 'title': 'MACE for ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '12 Month DAPT Arm', 'description': 'placebo + aspirin\n\nplacebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.'}, {'id': 'OG001', 'title': '30 Month DAPT Arm', 'description': 'clopidogrel + aspirin OR prasugrel + aspirin\n\nclopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.'}], 'timeFrame': '12 through 30 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.'}, {'type': 'SECONDARY', 'title': 'ST for ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '12 Month DAPT Arm', 'description': 'placebo + aspirin\n\nplacebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.'}, {'id': 'OG001', 'title': '30 Month DAPT Arm', 'description': 'clopidogrel + aspirin OR prasugrel + aspirin\n\nclopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.'}], 'timeFrame': '12 through 30 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.'}, {'type': 'SECONDARY', 'title': 'Major Bleeding for ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '12 Month DAPT Arm', 'description': 'placebo + aspirin\n\nplacebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.'}, {'id': 'OG001', 'title': '30 Month DAPT Arm', 'description': 'clopidogrel + aspirin OR prasugrel + aspirin\n\nclopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.'}], 'timeFrame': '12 through 30 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.'}, {'type': 'SECONDARY', 'title': 'MACE for Treatment Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '12 Month DAPT Arm', 'description': 'placebo + aspirin\n\nplacebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.'}, {'id': 'OG001', 'title': '30 Month DAPT Arm', 'description': 'clopidogrel + aspirin OR prasugrel + aspirin\n\nclopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.'}], 'timeFrame': '12 through 30 months and 12 through 33 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.'}, {'type': 'SECONDARY', 'title': 'ST for Treatment Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '12 Month DAPT Arm', 'description': 'placebo + aspirin\n\nplacebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.'}, {'id': 'OG001', 'title': '30 Month DAPT Arm', 'description': 'clopidogrel + aspirin OR prasugrel + aspirin\n\nclopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.'}], 'timeFrame': '12 through 30 months and 12 through 33 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.'}, {'type': 'SECONDARY', 'title': 'Major Bleeding for Treatment Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '12 Month DAPT Arm', 'description': 'placebo + aspirin\n\nplacebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.'}, {'id': 'OG001', 'title': '30 Month DAPT Arm', 'description': 'clopidogrel + aspirin OR prasugrel + aspirin\n\nclopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.'}], 'timeFrame': '12 through 30 months and 12 through 33 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Second Enrollment Phase of XIENCE V® USA', 'description': 'Additional 3000 patients recruited in the second enrollment phase treated with the XIENCE V EECSS who are free from events (death, MI, repeat coronary revascularization, stroke, ST, or major bleeding - "severe" or "moderate" by GUSTO classification) in the first year after the index procedure, and are compliant with DAPT will be identified as prospective patients for the AV-DAPT cohort. A total of 870 Patients who are considered as part of the AV-DAPT cohort will continue with Aspirin therapy and will be randomized at 12 months post index procedure to 18 months of either active treatment with thienopyridines or placebo. Clinical follow-up will occur at 15, 24, 30 and 33 months. These patients will be followed by Abbott Vascular.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2997'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2960'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Additional 3000 patients were enrolled in the second enrollment phase and had completed phase I at 1 year. In phase II, 870 patients from these were transferred to AV-DAPT cohort and followed from 1 year to 33 months, and the remaining who did not participate in AV-DAPT cohort will be followed for the first year only.', 'preAssignmentDetails': 'Outcome measures of participants of XIENCE V USA trial of phase I followed up until 1 year from index procedure are available in the study with ID NCT00676520.\n\nOutcome measures of participants belonging to XIENCE V USA long-term follow-up cohort of phase II (followed up from year 1 to year 5) are available in the study with ID NCT01120379.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2997', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Second Enrollment Phase of XIENCE V® USA', 'description': 'Additional 3000 patients recruited in the second enrollment phase treated with the XIENCE V EECSS who are free from events (death, MI, repeat coronary revascularization, stroke, ST, or major bleeding - "severe" or "moderate" by GUSTO classification) in the first year after the index procedure, and are compliant with DAPT will be identified as prospective patients for the AV-DAPT cohort. A total of 870 Patients who are considered as part of the AV-DAPT cohort will continue with Aspirin therapy and will be randomized at 12 months post index procedure to 18 months of either active treatment with thienopyridines or placebo. Clinical follow-up will occur at 15, 24, 30 and 33 months. These patients will be followed by Abbott Vascular.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.27', 'spread': '10.39', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 65 years', 'categories': [{'measurements': [{'value': '1587', 'groupId': 'BG000'}]}]}, {'title': '>= 65 to < 75 years', 'categories': [{'measurements': [{'value': '922', 'groupId': 'BG000'}]}]}, {'title': '>= 75 years', 'categories': [{'measurements': [{'value': '488', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '870', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2127', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaskan Native', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}, {'title': 'Black or African Heritage', 'categories': [{'measurements': [{'value': '231', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawaiian or Pacific Islander', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '2577', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '117', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Patient may be counted in more than one category', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline characteristics are provided for 2997 patients recruited in the second enrollment phase.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 870}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'dispFirstSubmitDate': '2015-01-20', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-27', 'studyFirstSubmitDate': '2010-04-16', 'dispFirstSubmitQcDate': '2015-04-08', 'resultsFirstSubmitDate': '2015-07-31', 'studyFirstSubmitQcDate': '2010-04-19', 'dispFirstPostDateStruct': {'date': '2015-05-14', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-05-12', 'studyFirstPostDateStruct': {'date': '2010-04-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Composite of All Death, MI and Stroke (Defined as MACE)', 'timeFrame': '12-33 months post-stent'}, {'measure': 'Incidence of ARC Definite or Probable ST', 'timeFrame': '12-33 months post-stent'}, {'measure': 'Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined)', 'timeFrame': '12-33 months post-stent'}], 'secondaryOutcomes': [{'measure': 'MACE for ITT Population', 'timeFrame': '12 through 30 months'}, {'measure': 'ST for ITT Population', 'timeFrame': '12 through 30 months'}, {'measure': 'Major Bleeding for ITT Population', 'timeFrame': '12 through 30 months'}, {'measure': 'MACE for Treatment Population', 'timeFrame': '12 through 30 months and 12 through 33 months'}, {'measure': 'ST for Treatment Population', 'timeFrame': '12 through 30 months and 12 through 33 months'}, {'measure': 'Major Bleeding for Treatment Population', 'timeFrame': '12 through 30 months and 12 through 33 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['drug eluting stents', 'Stents', 'Angioplasty', 'Stent thrombosis', 'antiplatelet treatment'], 'conditions': ['Chronic Total Occlusion of Coronary Artery', 'Vascular Disease', 'Myocardial Ischemia', 'Coronary Artery Stenosis', 'Coronary Disease', 'Coronary Artery Disease', 'Coronary Restenosis']}, 'descriptionModule': {'briefSummary': 'XIENCE V USA is a prospective, multi-center, multi-cohort postapproval study. The objectives of this study are\n\n* To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings, and\n* To support the Food and Drug Administration (FDA) dual antiplatelet therapy (DAPT) initiative. This initiative is designed to evaluate the composite of all death, myocardial infarction (MI) and stroke (MACCE) and the survival of patients that are free from Academic Research Consortium (ARC) definite or probable stent thrombosis (ST) and that have been treated with drug eluting stents (DES) and extended dual antiplatelet therapy.', 'detailedDescription': 'This prospective, multi-center, randomized, double-blind AV-DAPT study cohort is designed to collect data to support the FDA DAPT initiative. The protocol for AV-DAPT cohort is designed according to the HCRI-DAPT (NCT00977938) study protocol, Study IDE # G080186.\n\nA total 8040 patients (5034 in initial enrollment phase and additional \\~3000 patients in the second enrollment phase) enrolled in the XIENCE V USA (NCT00676520) had completed Phase I and were evaluated at 1 year.\n\nThese patients were transferred to the following cohorts in Phase II and followed-up for 1-5 years:\n\nThe long-term follow-up cohort of phase II (NCT01120379) consisted of 5020 patients from the first enrollment phase who were not transferred to the HCRI- DAPT study and remained in the study beyond 1 year.\n\nPatients from the additional 3000 treated with the XIENCE V EECSS who are free from events (death, MI, repeat coronary revascularization, stroke, ST, or major bleeding - "severe" or "moderate" by GUSTO classification) in the first year after the index procedure, and are compliant with DAPT will be identified as prospective patients for the AV-DAPT cohort. A total of 870 Patients who are considered as part of the AV-DAPT cohort will continue with Aspirin therapy and will be randomized at 12 months post index procedure to 18 months of either active treatment with thienopyridines or placebo. Clinical follow-up will occur at 15, 24, 30 and 33 months. These patients will be followed by Abbott Vascular.\n\nThe remaining patients from the additional 3000 patients who did not participate in AV-DAPT cohort will be followed for the first year only. A study completion form will be filled out and the patients will not be followed beyond their 1 year visit.\n\nThe participants enrolled in this study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are enrolled into the XIENCE V USA Study Phase I\n* The patient agrees to participate in this study by signing the Institutional Review Board (IRB) approved informed consent form. Alternatively, the patient\'s legally authorized representative agrees to the patient\'s participation in this study and signs the informed consent form.\n\nExclusion Criteria:\n\n* The inability to obtain an informed consent is an exclusion criterion.\n\nPatients must meet the following criteria to be eligible for randomization in the study:\n\n* Patient is "12 Month Clear": "12-Month Clear" patients are free from death, MI, stroke, repeat coronary revascularization, major bleeding - "severe" or "moderate" by GUSTO classification, and ST 12 months after stent implantation. Staged PCI is allowed (same stent type as index); repeat PCI and peri-procedural myocardial infarction occurring with the index procedure or repeat procedure within the first 6 weeks will not be considered exclusionary events for the definition of "12 Month Clear".\n* Patient is "DAPT Compliant": During the open label portion of this study (time 0-12 months), a patient is considered compliant with the thienopyridine therapy for the purposes of eligibility if they take between 80% and 120% of the prescribed drug in a given period without an interruption of therapy longer than 14 days. This information will be ascertained via data collected at the patient interviews at 6 and 12 months post-procedure. Compliance at both time points is required to be considered "clear".\n* Patient completes 1 year visit within ± 30 days window.\n\nPatients will be excluded from randomization if any of the following criteria are met:\n\n* Pregnant women.\n* Switched thienopyridine type or dose within 6 months prior to randomization. Note: Thienopyridine switching during the open label portion of this study is discouraged.\n* PCI or cardiac surgery between 6 weeks post index procedure and randomization.\n* Planned surgery necessitating discontinuation of antiplatelet therapy within the 21 months following randomization.\n* Current medical condition with a life expectancy of less than 3 years.\n* Patients on warfarin or similar anticoagulant therapy.'}, 'identificationModule': {'nctId': 'NCT01106534', 'acronym': 'XVU-AV DAPT', 'briefTitle': 'XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'XIENCE V® Everolimus Eluting Coronary Stent System USA Post- Approval Study (XIENCE V® USA DAPT Cohort) (XVU-AV DAPT)', 'orgStudyIdInfo': {'id': '06-374C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '12 month DAPT arm', 'description': 'placebo + aspirin', 'interventionNames': ['Drug: placebo + aspirin', 'Device: XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '30 month DAPT arm', 'description': 'clopidogrel + aspirin OR prasugrel + aspirin', 'interventionNames': ['Drug: clopidogrel + aspirin OR prasugrel + aspirin', 'Device: XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)']}], 'interventions': [{'name': 'placebo + aspirin', 'type': 'DRUG', 'description': 'This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.', 'armGroupLabels': ['12 month DAPT arm']}, {'name': 'clopidogrel + aspirin OR prasugrel + aspirin', 'type': 'DRUG', 'otherNames': ['Dual Antiplatelet Therapy'], 'description': 'This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.', 'armGroupLabels': ['30 month DAPT arm']}, {'name': 'XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)', 'type': 'DEVICE', 'description': 'XIENCE V Everolimus Eluting Coronary Stent System assigned to both the arms.', 'armGroupLabels': ['12 month DAPT arm', '30 month DAPT arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35235', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Birmingham Heart Clinic, PC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36532', 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