Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-02-19 @ 10:07 PM
Study NCT ID:
NCT02829151
Status:
UNKNOWN
Last Update Posted:
2019-01-14
First Post:
2016-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Cilostazol-based Triple Antiplatelet Therapy Versus Dual Antiplatelet Therapy for Outcomes of below-the Knee Endovascular Intervention in Patients With Critical Limb Ischemia (TAP CLI Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000089802', 'term': 'Chronic Limb-Threatening Ischemia'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007511', 'term': 'Ischemia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D000077144', 'term': 'Clopidogrel'}, {'id': 'D000077407', 'term': 'Cilostazol'}], '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': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D011804', 'term': 'Quinolines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 390}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-10', 'studyFirstSubmitDate': '2016-06-20', 'studyFirstSubmitQcDate': '2016-07-11', 'lastUpdatePostDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse events', 'timeFrame': '12 months', 'description': 'A composition event of all-cause death, myocardial infarction, stroke, repeat revascularization of the target lesion, and unexpected amputation of the target limb between TAP group and DAP A group (aspirin \\& clopidogrel)'}], 'secondaryOutcomes': [{'measure': 'Major adverse event between TAP group and DAP B group', 'timeFrame': '12 months'}, {'measure': 'Adverse limb event among the 3 patient groups', 'timeFrame': '12 months'}, {'measure': 'Bleeding complications among the patient groups', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peripheral artery disease', 'Critical limb ischemia', 'Angioplasty', 'Antiplatelet therapy'], 'conditions': ['Critical Limb Ischemia']}, 'descriptionModule': {'briefSummary': '* Prospective, randomized, controlled, multi-center study\n* A total of 390 subjects with critical limb ischemia will be included according to inclusion and exclusion criteria.\n* Patients will be randomized in a 1:1:1 manner into triple antiplatelet therapy (TAP: aspirin, clopidogrel, cilostazol) group, dual antiplatelet therapy (DAP: aspirin, clopidogrel) A group, or DAP (aspirin, cilostazol) B group.\n* All patients will be treated with angioplasty for critical limb ischemia.\n* Patients will be followed clinically for 1 year after the procedure.\n* Ankle-brachial index and Image study follow-up (Duplex US or CT angiography) will be performed at 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 19 years old\n* Patients with critical limb ischemia (Rutherford 4 \\& 5)\n* Successful below-the knee endovascular intervention.\n\nExclusion Criteria:\n\n* Major bleeding event within recent 3 months or high risk of major bleeding\n* Patients requiring anticoagulation\n* Allergic reactions to antiplatelet drugs\n* Acute limb ischemia\n* Severe hepatic dysfunction (3 times normal reference values)\n* Pregnant women or women with potential childbearing\n* Life expectancy \\< 1 year due to comorbidity\n* Previous amputations in the target limb'}, 'identificationModule': {'nctId': 'NCT02829151', 'briefTitle': 'Comparison of Cilostazol-based Triple Antiplatelet Therapy Versus Dual Antiplatelet Therapy for Outcomes of below-the Knee Endovascular Intervention in Patients With Critical Limb Ischemia (TAP CLI Study)', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Comparison of Cilostazol-based Triple Antiplatelet Therapy Versus Dual Antiplatelet Therapy for Outcomes of below-the Knee Endovascular Intervention in Patients With Critical Limb Ischemia (TAP CLI Study)', 'orgStudyIdInfo': {'id': '4-2015-1104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Triple antiplatelet therapy group', 'description': 'Patient group with triple antiplatelet therapy using aspirin, clopidogrel, and cilostazol', 'interventionNames': ['Drug: Triple antiplatelet therapy (aspirin (100 mg), clopidogrel (75 mg), and cilostazol (200 mg) )']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DAP (Dual antiplatelet therapy) A', 'description': 'Patient group with dual antiplatelet therapy using aspirin and clopidogrel', 'interventionNames': ['Drug: Dual antiplatelet therapy (aspirin (100 mg) and clopidogrel (75 mg)) using aspirin and clopidogrel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DAP (Dual antiplatelet therapy) B', 'description': 'Patient group with angioplasty using aspirin and cilostazol', 'interventionNames': ['Drug: Dual antiplatelet therapy (aspirin (100 mg) and cilostazol (200 mg)) using aspirin and cilostazol']}], 'interventions': [{'name': 'Triple antiplatelet therapy (aspirin (100 mg), clopidogrel (75 mg), and cilostazol (200 mg) )', 'type': 'DRUG', 'description': 'Combination antiplatelet therapy using aspirin (100 mg), clopidogrel (75 mg), and cilostazol (200 mg) after the index angioplasty', 'armGroupLabels': ['Triple antiplatelet therapy group']}, {'name': 'Dual antiplatelet therapy (aspirin (100 mg) and clopidogrel (75 mg)) using aspirin and clopidogrel', 'type': 'DRUG', 'description': 'Combination antiplatelet therapy using aspirin (100 mg) and clopidogrel (75 mg) after the index angioplasty', 'armGroupLabels': ['DAP (Dual antiplatelet therapy) A']}, {'name': 'Dual antiplatelet therapy (aspirin (100 mg) and cilostazol (200 mg)) using aspirin and cilostazol', 'type': 'DRUG', 'description': 'Combination antiplatelet therapy using aspirin (100 mg) and cilostazol (200 mg) after the index angioplasty', 'armGroupLabels': ['DAP (Dual antiplatelet therapy) B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Dong-Hoon Choi, MD', 'role': 'CONTACT', 'email': 'cdhlyj@yuhs.ac', 'phone': '82 2 2228 8449'}], 'facility': 'Division of Cardiology, Department of Internal Medicine, Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}