Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2026-03-03 @ 5:04 PM
Study NCT ID:
NCT03119012
Status:
TERMINATED
Last Update Posted:
2024-04-22
First Post:
2017-04-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
P2Y12 Inhibitor Monotherapy Versus Extended DAPT in Patients Treated With Bioresorbable Scaffold
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077144', 'term': 'Clopidogrel'}, {'id': 'D000077486', 'term': 'Ticagrelor'}, {'id': 'D001241', 'term': 'Aspirin'}], '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'}, {'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, open label, two-arm, randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'whyStopped': 'cannot use bioabsorbable scaffold', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-19', 'studyFirstSubmitDate': '2017-04-01', 'studyFirstSubmitQcDate': '2017-04-13', 'lastUpdatePostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A composite of death, myocardial infarction, and cerebrovascular events', 'timeFrame': '36 months after the index procedure', 'description': 'defined as MACCE'}], 'secondaryOutcomes': [{'measure': 'All-cause death', 'timeFrame': '36 months after the index procedure', 'description': 'Any death'}, {'measure': 'Cardiac death', 'timeFrame': '36 months after the index procedure', 'description': 'ARC definition'}, {'measure': 'Myocardial infarction', 'timeFrame': '36 months after the index procedure', 'description': 'ARC definition'}, {'measure': 'Cerebrovascular accident', 'timeFrame': '36 months after the index procedure', 'description': 'ischemic and hemorrhagic'}, {'measure': 'target lesion revascularization (TLR)', 'timeFrame': '36 months after the index procedure', 'description': 'ischemic driven or all'}, {'measure': 'Target vessel revascularization (TVR)', 'timeFrame': '36 months after the index procedure', 'description': 'ischemic driven or all'}, {'measure': 'Any revascularization', 'timeFrame': '36 months after the index procedure', 'description': 'ischemic driven or all'}, {'measure': 'Stent thrombosis (ST)', 'timeFrame': '36 months after the index procedure', 'description': 'definite or probable ST by Academic Research Consortium (ARC) definition'}, {'measure': 'Bleeding Academic Research Consortium (BARC) bleeding 2,3, or 5', 'timeFrame': '36 months after the index procedure', 'description': 'Safety Endpoints, defined as actionable, overt, and fatal bleeding by BARC definition'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bioresorbable scaffold', 'Dual antiplatelet therapy', 'P2Y12 receptor inhibitor', 'Coronary artery disease'], 'conditions': ['Coronary Artery Disease', 'Stents', 'Atherosclerosis']}, 'descriptionModule': {'briefSummary': 'This study aimed to compare the efficacy and safety of P2Y12 inhibitor monotherapy versus extended dual antiplatelet therapy (DAPT) following 12-month of DAPT in patients undergoing percutaneous coronary intervention (PCI) with bioresorbable scaffold (BRS)', 'detailedDescription': "After the development of second generation drug-eluting stent (DES), clinical outcomes including in-stent restenosis have been dramatically improved in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) compared with bare metal stent or first generation DES era. However, interventional cardiologist still concern about late adverse cardiac events including stent thrombosis (ST) in patients who received implantation of permanent metallic stent. Bioresorbable scaffold (BRS) have been developed to provide mechanical support and drug-delivery function similar to those of DES for approximately 1 year, followed by complete bioresorption over several years. It has the advantages of reducing the risk of late ST and maintaining of normal vascular function because these novel devices are expected to leave no permanent materials within the vessel. Although there was no significant difference from previous randomized controlled studies for evaluating the clinical outcomes at 1-year between BRS and DES, recently documented ARSORB II trial, which compared 3-year outcomes between BRS and DES, show that patients treated with BRS had a higher risk of device-oriented composite endpoint mainly driven by target vessel myocardial infarction (MI) compared to those with DES. In addition, in several case reports, the late ST after discontinuation of dual anti-platelet therapy (DAPT) was reported in patients who underwent BRS implantation. Therefore, the efficacy of extended DAPT and needs for optimal DAPT duration in patients treated with BRS have been emerged. In the DAPT study, randomized controlled trial including approximately 10,000 patients, DAPT beyond 1 year after placement of a DES, as compared with aspirin therapy alone, significantly reduced the risks of major adverse cardiovascular and cerebrovascular events (MACCE) and ST. However, extend use of DAPT increases bleeding risk and cost. Endoscopic, dental, and surgical procedures are often delayed due to extended DAPT, which may affect the patient's quality of life. In addition, there was no significant difference in all-cause mortality between extended DAPT and aspirin monotherapy in the DAPT study because of increased bleeding risk in extended DAPT group. Therefore, to determine the optimal or minimal necessary duration of DAPT is very important. The other important issue is that which antiplatelet agent is more appropriate after DAPT. In CAPRIE (Clopidogrel versus Aspirin in Patients at Risk of Ischaemic Events) trial, clopidogrel showed a superior efficacy in preventing ischemic events compared with aspirin and the incidence of gastrointestinal bleeding was significantly lower with clopidogrel than with aspirin. Moreover, clopidogrel monotherapy was associated with a reduced risk of ischemic events without increased bleeding risk compared with aspirin monotherapy in patients receiving DES after 12-month DAPT. However, current guidelines still recommend aspirin monotherapy after 6-12 months of DAPT in patients treated with DES, there were no data for evaluating the optimal duration of DAPT and preferred choice of monotherapy in patients treated with BRS. Through results of previous studies, the authors postulated that P2Y12 antagonist monotherapy, which might have superior ability to prevent ischemic event compared to aspirin monotherapy, had similar risk of ischemic events with lower risk of bleeding complication compared with extended DAPT in patients who received BRS implantation with 12-month DAPT. Therefore, in the SMART-CHOICE II trial, we will test noninferiority of P2Y12 antagonist monotherapy compared with aspirin plus P2Y12 antagonist after 12-month of DAPT in patients treated with BRS.\n\nStratification: presence of diabetes mellitus, clinical presentation (acute coronary syndrome), type of P2Y12 inhibitor (clopidogrel or ticagrelor), and investigational center."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject must be at least 19 years of age.\n* Patients who do not occur a major adverse cardiac and cerebral events (MACCE) at 12-month after BRS implantation\n* Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving P2Y12 antagonist monotherapy or aspirin plus P2Y12 antagonist and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.\n\nExclusion Criteria:\n\n* Active bleeding\n* Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study\n* Non-cardiac co-morbid conditions are present with life expectancy \\<2 year or that may result in protocol non-compliance (per site investigator's medical judgment)."}, 'identificationModule': {'nctId': 'NCT03119012', 'acronym': 'SMART-CHOICEII', 'briefTitle': 'P2Y12 Inhibitor Monotherapy Versus Extended DAPT in Patients Treated With Bioresorbable Scaffold', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'SMart Angioplasty Research Team: Comparison Between P2Y12 Inhibitor MonotHerapy and Dual Antiplatelet Therapy in Patients UndergOing Implantation of Coronary BiorEsorbable Scaffold II: (SMART-CHOICE II) Trial', 'orgStudyIdInfo': {'id': 'CHOICEII16453143'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'P2Y12 receptor inhibitor monotherapy arm', 'description': 'In patients who do not occur a MACCE until 12-month after BRS implantation, P2Y12 receptor inhibitor monotherapy arm will be received clopidogrel 75mg qd or ticagrelor 60mg bid during follow-up period (24 months after randomization).', 'interventionNames': ['Drug: Clopidogrel', 'Drug: Ticagrelor']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Extended DAPT arm', 'description': 'In patients who do not occur a MACCE until 12-month after BRS implantation, Extended DAPT arm will be received aspirin 100mg qd plus P2Y12 receptor inhibitor (clopidogrel 75mg qd or ticagrelor 60mg bid) during follow-up period (24 months after randomization).', 'interventionNames': ['Drug: Clopidogrel', 'Drug: Ticagrelor', 'Drug: Aspirin']}], 'interventions': [{'name': 'Clopidogrel', 'type': 'DRUG', 'otherNames': ['Clopidogrel or its generic'], 'description': '75mg/day', 'armGroupLabels': ['Extended DAPT arm', 'P2Y12 receptor inhibitor monotherapy arm']}, {'name': 'Ticagrelor', 'type': 'DRUG', 'otherNames': ['Brillinta'], 'description': '120mg/day', 'armGroupLabels': ['Extended DAPT arm', 'P2Y12 receptor inhibitor monotherapy arm']}, {'name': 'Aspirin', 'type': 'DRUG', 'otherNames': ['Any commercially available aspirin'], 'description': '100mg/day', 'armGroupLabels': ['Extended DAPT arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06351', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Joo-Yong Hahn, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Samsung Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Joo-Yong Hahn', 'investigatorAffiliation': 'Samsung Medical Center'}}}}