Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2026-01-13 @ 11:44 AM
Study NCT ID:
NCT02959606
Status:
UNKNOWN
Last Update Posted:
2017-07-27
First Post:
2016-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SAFE (Sarpogrelate Anplone in Femoro-popliteal Artery Intervention Efficacy) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C064294', 'term': 'sarpogrelate'}, {'id': 'D000077144', 'term': 'Clopidogrel'}], 'ancestors': [{'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'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': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 272}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-26', 'studyFirstSubmitDate': '2016-11-08', 'studyFirstSubmitQcDate': '2016-11-08', 'lastUpdatePostDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Restenosis rate (50%>) in 6 months by CT angiography', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Target lesion restenosis(TLR) in 6 months', 'timeFrame': '6 months'}, {'measure': 'Major bleeding complication', 'timeFrame': '6 months'}, {'measure': 'Ipsilateral major amputation', 'timeFrame': '6 months'}, {'measure': 'All-cause mortality', 'timeFrame': '6 months'}, {'measure': 'All adverse events', 'timeFrame': '6 months'}]}, 'conditionsModule': {'conditions': ['Peripheral Arterial Disease']}, 'referencesModule': {'references': [{'pmid': '36781928', 'type': 'DERIVED', 'citation': 'Han A, Lee T, Lee J, Song SW, Lee SS, Jung IM, Kang JM, Gwon JG, Yun WS, Cho YP, Ko H, Park YJ, Min SK. A multicenter, randomized, open-labelled, non-inferiority trial of sustained-release sarpogrelate versus clopidogrel after femoropopliteal artery intervention. Sci Rep. 2023 Feb 13;13(1):2502. doi: 10.1038/s41598-023-29006-z.'}, {'pmid': '28938905', 'type': 'DERIVED', 'citation': 'Ahn S, Lee J, Min SK, Ha J, Min SI, Kim SY, Cho MJ, Cho S; SAFE study investigators. SAFE (Sarpogrelate Anplone in Femoro-popliteal artery intervention Efficacy) study: study protocol for a randomized controlled trial. Trials. 2017 Sep 22;18(1):439. doi: 10.1186/s13063-017-2155-5.'}]}, 'descriptionModule': {'briefSummary': 'After endovascular treatment (EVT) for peripheral artery disease (PAD), dual antiplatelet therapy (DAAT) of aspirin (ASA) and clopidogrel are currently drug of choice to prevent occlusion. Anplone SR®, controlled-released Sarpogrelate hydrochloride, has been introduced as an anti-platelet agent for the drug of PAD. The aim of this study was to compare the efficacy and safety of Anplone + aspirin and clopidogrel + aspirin in patients who underwent EVT for femoro-popliteal occlusive disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult, \\>18 years old\n2. Angiographically-confirmed significant femoro-popliteal (FP) stenosis or occlusion by atherosclerosis\n3. Successful FP intervention; residual stenosis \\<30%\n4. Without significant residual inflow disease; Intact iliac artery inflow (with or without intervention of iliac or below knee arteries)\n5. patent outflow status; at least 1 arterial runoff in below knee arteries\n6. All kind of fem-pop intervention including POBA, stent, DCB, DES for TASC A\\~ D\n\nExclusion Criteria:\n\n1. At risk of hemorrhage, bleeding tendency or thrombophilia\n2. Acute limb ischemia / inflammatory arterial disease\n3. Contraindication or allergic to ASA, clopidogrel, Anplone\n4. Medication of warfarin\n5. Pregnancy, hepatic dysfunction, thrombocytopenia\n6. Previous FP bypass or intervention\n7. Impossible to stop clopidogrel before EVT'}, 'identificationModule': {'nctId': 'NCT02959606', 'briefTitle': 'SAFE (Sarpogrelate Anplone in Femoro-popliteal Artery Intervention Efficacy) Study', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'SAFE (Sarpogrelate Anplone in Femoro-popliteal Artery Intervention Efficacy) Study : a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SAFE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sarpogrelate SR 300mg + ASA', 'description': 'Sarpogrelate HCl SR 300mg is administrated to patients with PAD for 6 weeks after EVT for femoro-popliteal regions.\n\nOther Name: Anplone SR', 'interventionNames': ['Drug: Sarpogrelate SR 300mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clopidogrel + ASA', 'description': 'Clopidogrel is administrated to patients with PAD for 6 weeks after EVT for femoro-popliteal regions.\n\nOther Name: Plavix', 'interventionNames': ['Drug: Clopidogrel']}], 'interventions': [{'name': 'Sarpogrelate SR 300mg', 'type': 'DRUG', 'otherNames': ['Anplone SR'], 'armGroupLabels': ['Sarpogrelate SR 300mg + ASA']}, {'name': 'Clopidogrel', 'type': 'DRUG', 'armGroupLabels': ['Clopidogrel + ASA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seung-Kee Min, MD.', 'role': 'CONTACT', 'email': 'skminmd@snuh.org', 'phone': '+82.2-2072-0297'}], 'facility': 'Seung-Kee Min,', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Seung-Kee Min, MD.PhD.', 'role': 'CONTACT', 'email': 'skminmd@snuh.org', 'phone': '+82.2-2072-0297'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Seung-Kee Min', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}