Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2026-04-16 @ 8:39 AM
Study NCT ID:
NCT03114995
Status:
COMPLETED
Last Update Posted:
2018-07-17
First Post:
2017-04-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tailored Use of Tirofiban for Non-ST-elevation Acute Coronary Syndrome Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072658', 'term': 'Non-ST Elevated Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077466', 'term': 'Tirofiban'}], 'ancestors': [{'id': 'D014443', 'term': 'Tyrosine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ytjmd@snubh.org', 'phone': '+82-31-787-7031', 'title': 'Dr. Tae-Jin Youn', 'organization': 'Cardiovascular Center, Seoul National University Bundang Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The difference in the distribution of PRU values of subjects estimated from previous literatures leading to small numbers of subjects assigned to the study group'}}, 'adverseEventsModule': {'timeFrame': '1 month', 'eventGroups': [{'id': 'EG000', 'title': 'Group A (High Platelet Reactivity - Tirofiban)', 'description': 'Patients with high platelet reactivity unit (230 or higher) Tirofiban administered dose: 0.4 μg/kg/min continuous infusion for 30 min and then 0.10 μg/kg/min continuous infusion for 12 h\n\nTirofiban', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 4, 'seriousNumAtRisk': 30, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control C1 (High Platelet Reactivity - no Tirofiban)', 'description': 'Patients with high platelet reactivity unit (230 or higher) Tirofiban was not administered', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 1, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Control C2 (Low Platelet Reactivity - no Tirofiban)', 'description': 'Patients with low platelet reactivity unit (less than 230) Tirofiban was not administered', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 8, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Minor bleeding', 'notes': 'Minor bleeding defined by TIMI criteria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 78, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under Curve of Serial Cardiac Biomarkers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (High Platelet Reactivity - Tirofiban)', 'description': 'Patients with high platelet reactivity unit (230 or higher) Tirofiban administered dose: 0.4 μg/kg/min continuous infusion for 30 min and then 0.10 μg/kg/min continuous infusion for 12 h\n\nTirofiban'}, {'id': 'OG001', 'title': 'Control C1 (High Platelet Reactivity - no Tirofiban)', 'description': 'Patients with high platelet reactivity unit (230 or higher) Tirofiban was not administered'}, {'id': 'OG002', 'title': 'Control C2 (Low Platelet Reactivity - no Tirofiban)', 'description': 'Patients with low platelet reactivity unit (less than 230) Tirofiban was not administered'}], 'classes': [{'title': 'Troponin I', 'categories': [{'measurements': [{'value': '197.2', 'groupId': 'OG000', 'lowerLimit': '41.5', 'upperLimit': '395.7'}, {'value': '38.0', 'groupId': 'OG001', 'lowerLimit': '8.9', 'upperLimit': '313.9'}, {'value': '121.4', 'groupId': 'OG002', 'lowerLimit': '43.7', 'upperLimit': '481.8'}]}]}, {'title': 'creatine kinase-MB isoenzyme', 'categories': [{'measurements': [{'value': '252.5', 'groupId': 'OG000', 'lowerLimit': '48.0', 'upperLimit': '470.1'}, {'value': '92.7', 'groupId': 'OG001', 'lowerLimit': '39.1', 'upperLimit': '402.1'}, {'value': '185.6', 'groupId': 'OG002', 'lowerLimit': '79.8', 'upperLimit': '425.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0,6,12,18,24,30,36 hours', 'description': 'An area under the curve of serial levels of Troponin I and creatine kinase-MB isoenzyme during 36 hours', 'unitOfMeasure': 'Hours*ng/ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Periprocedural Myonecrosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (High Platelet Reactivity - Tirofiban)', 'description': 'Patients with high platelet reactivity unit (230 or higher) Tirofiban administered dose: 0.4 μg/kg/min continuous infusion for 30 min and then 0.10 μg/kg/min continuous infusion for 12 h\n\nTirofiban'}, {'id': 'OG001', 'title': 'Control C1 (High Platelet Reactivity - no Tirofiban)', 'description': 'Patients with high platelet reactivity unit (230 or higher) Tirofiban was not administered'}, {'id': 'OG002', 'title': 'Control C2 (Low Platelet Reactivity - no Tirofiban)', 'description': 'Patients with low platelet reactivity unit (less than 230) Tirofiban was not administered'}], 'classes': [{'title': 'Troponin I', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'creatine kinase-MB isoenzyme', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0,6,12,18,24,30,36 hours', 'description': 'Percentage of participants with periprocedural myonecrosis under the criteria described below.\n\nWhen the cardiac biomarkers before the procedure were within the 99th percentile upper reference limit (URL), more than a 5-fold elevation in the URL within 12 hours after percutaneous coronary intervention (PCI) was defined as periprocedural myonecrosis. If the cardiac biomarker level was already above the 99th percentile URL before the procedure and the trend was stationary or decreasing, a ≥20% increase compared to the previous level was considered periprocedural myonecrosis. If the trend was still increasing, the levels at the post-6 hour and 12-hour were compared to determine periprocedural myonecrosis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A (High Platelet Reactivity - Tirofiban)', 'description': 'Patients with high platelet reactivity (HPR) unit (230 or higher) Tirofiban administered dose: 0.4 μg/kg/min continuous infusion for 30 min and then 0.10 μg/kg/min continuous infusion for 12 h\n\nTirofiban'}, {'id': 'FG001', 'title': 'Control C1 (High Platelet Reactivity - no Tirofiban)', 'description': 'Patients with high platelet reactivity unit (230 or higher) Tirofiban was not administered'}, {'id': 'FG002', 'title': 'Control C2(Low Platelet Reactivity - no Tirofiban)', 'description': 'Patients with low platelet reactivity unit (less than 230) Tirofiban was not administered'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '78'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '78'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Consecutively enrolled patients who are already stabilized with standard medical treatment and diagnosed with Non-ST elevation acute coronary syndrome (NSTE-ACS) at Seoul National University Bundang Hospital from February 2012 to October 2015'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '138', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A (High Platelet Reactivity - Tirofiban)', 'description': 'Patients with high platelet reactivity unit (230 or higher) Tirofiban administered dose: 0.4 μg/kg/min continuous infusion for 30 min and then 0.10 μg/kg/min continuous infusion for 12 h\n\nTirofiban'}, {'id': 'BG001', 'title': 'Control C1 (High Platelet Reactivity - no Tirofiban)', 'description': 'Patients with high platelet reactivity unit (230 or higher) Tirofiban was not administered'}, {'id': 'BG002', 'title': 'Control C2 (Low Platelet Reactivity - no Tirofiban)', 'description': 'Patients with low platelet reactivity unit (less than 230) Tirofiban was not administered'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.0', 'spread': '12.8', 'groupId': 'BG000'}, {'value': '64.5', 'spread': '12.0', 'groupId': 'BG001'}, {'value': '62.9', 'spread': '10.1', 'groupId': 'BG002'}, {'value': '64.8', 'spread': '11.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '109', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-18', 'studyFirstSubmitDate': '2017-04-11', 'resultsFirstSubmitDate': '2018-05-08', 'studyFirstSubmitQcDate': '2017-04-11', 'lastUpdatePostDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-08', 'studyFirstPostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under Curve of Serial Cardiac Biomarkers', 'timeFrame': '0,6,12,18,24,30,36 hours', 'description': 'An area under the curve of serial levels of Troponin I and creatine kinase-MB isoenzyme during 36 hours'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Periprocedural Myonecrosis', 'timeFrame': '0,6,12,18,24,30,36 hours', 'description': 'Percentage of participants with periprocedural myonecrosis under the criteria described below.\n\nWhen the cardiac biomarkers before the procedure were within the 99th percentile upper reference limit (URL), more than a 5-fold elevation in the URL within 12 hours after percutaneous coronary intervention (PCI) was defined as periprocedural myonecrosis. If the cardiac biomarker level was already above the 99th percentile URL before the procedure and the trend was stationary or decreasing, a ≥20% increase compared to the previous level was considered periprocedural myonecrosis. If the trend was still increasing, the levels at the post-6 hour and 12-hour were compared to determine periprocedural myonecrosis.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tirofiban', 'Resistance to antiplatelet agents'], 'conditions': ['Non-ST Elevation Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '18804738', 'type': 'RESULT', 'citation': "Patti G, Nusca A, Mangiacapra F, Gatto L, D'Ambrosio A, Di Sciascio G. Point-of-care measurement of clopidogrel responsiveness predicts clinical outcome in patients undergoing percutaneous coronary intervention results of the ARMYDA-PRO (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty-Platelet Reactivity Predicts Outcome) study. J Am Coll Cardiol. 2008 Sep 30;52(14):1128-33. doi: 10.1016/j.jacc.2008.06.038."}, {'pmid': '10595951', 'type': 'RESULT', 'citation': 'Hong MK, Mehran R, Dangas G, Mintz GS, Lansky AJ, Pichard AD, Kent KM, Satler LF, Stone GW, Leon MB. Creatine kinase-MB enzyme elevation following successful saphenous vein graft intervention is associated with late mortality. Circulation. 1999 Dec 14;100(24):2400-5. doi: 10.1161/01.cir.100.24.2400.'}, {'pmid': '19264239', 'type': 'RESULT', 'citation': 'Fung AY, Saw J, Starovoytov A, Densem C, Jokhi P, Walsh SJ, Fox RS, Humphries KH, Aymong E, Ricci DR, Webb JG, Hamburger JN, Carere RG, Buller CE. Abbreviated infusion of eptifibatide after successful coronary intervention The BRIEF-PCI (Brief Infusion of Eptifibatide Following Percutaneous Coronary Intervention) randomized trial. J Am Coll Cardiol. 2009 Mar 10;53(10):837-45. doi: 10.1016/j.jacc.2008.09.060.'}, {'pmid': '19231326', 'type': 'RESULT', 'citation': 'De Labriolle A, Lemesle G, Bonello L, Syed AI, Collins SD, Ben-Dor I, Pinto Slottow TL, Xue Z, Torguson R, Suddath WO, Satler LF, Kent KM, Pichard AD, Lindsay J, Waksman R. Prognostic significance of small troponin I rise after a successful elective percutaneous coronary intervention of a native artery. Am J Cardiol. 2009 Mar 1;103(5):639-45. doi: 10.1016/j.amjcard.2008.10.044. Epub 2009 Jan 17.'}, {'pmid': '18645057', 'type': 'RESULT', 'citation': 'Jeremias A, Kleiman NS, Nassif D, Hsieh WH, Pencina M, Maresh K, Parikh M, Cutlip DE, Waksman R, Goldberg S, Berger PB, Cohen DJ; Evaluation of Drug Eluting Stents and Ischemic Events (EVENT) Registry Investigators. Prevalence and prognostic significance of preprocedural cardiac troponin elevation among patients with stable coronary artery disease undergoing percutaneous coronary intervention: results from the evaluation of drug eluting stents and ischemic events registry. Circulation. 2008 Aug 5;118(6):632-8. doi: 10.1161/CIRCULATIONAHA.107.752428. Epub 2008 Jul 21.'}, {'pmid': '18549843', 'type': 'RESULT', 'citation': 'Cuisset T, Hamilos M, Sarma J, Sarno G, Wyffels E, Vanderheyden M, Barbato E, Bartunek J, De Bruyne B, Wijns W. Relation of low response to clopidogrel assessed with point-of-care assay to periprocedural myonecrosis in patients undergoing elective coronary stenting for stable angina pectoris. Am J Cardiol. 2008 Jun 15;101(12):1700-3. doi: 10.1016/j.amjcard.2008.02.054. Epub 2008 Apr 18.'}, {'pmid': '21232664', 'type': 'RESULT', 'citation': 'Suh JW, Lee SP, Park KW, Lee HY, Kang HJ, Koo BK, Cho YS, Youn TJ, Chae IH, Choi DJ, Rha SW, Bae JH, Kwon TG, Bae JW, Cho MC, Kim HS. Multicenter randomized trial evaluating the efficacy of cilostazol on ischemic vascular complications after drug-eluting stent implantation for coronary heart disease: results of the CILON-T (influence of CILostazol-based triple antiplatelet therapy ON ischemic complication after drug-eluting stenT implantation) trial. J Am Coll Cardiol. 2011 Jan 18;57(3):280-9. doi: 10.1016/j.jacc.2010.08.631.'}, {'pmid': '30348101', 'type': 'DERIVED', 'citation': 'Lee W, Suh JW, Park JJ, Yoon CH, Cho YS, Youn TJ, Chae IH. Effect of tailored use of tirofiban in patients with Non-ST-elevation acute coronary syndrome undergoing percutaneous coronary intervention: a randomized controlled trial. BMC Cardiovasc Disord. 2018 Oct 22;18(1):201. doi: 10.1186/s12872-018-0938-6.'}]}, 'descriptionModule': {'briefSummary': 'Investigators aimed to test the beneficial effect of tirofiban, a GPIIb/IIIa antagonist, for Non-ST-Elevation Acute Coronary Syndrome Patients who has high resistance to clopidogrel.', 'detailedDescription': "Some patients have a poor response to dual antiplatelet therapy (DAPT), and it can result in a poor prognosis after percutaneous coronary intervention (PCI). Devices like Ultegra Rapid Platelet Function Analyzer (VerifyNow®) enable us to quantify platelet reactivity quickly in the catheter laboratory. This means that the poor responders to DAPT can be identified, and the patients' outcomes can be improved by providing additional antiplatelet agents. Tirofiban, a GP IIb/IIIa inhibitor, is a potent antiplatelet agent which is recommended for Non-ST-Elevation acute coronary syndrome (NSTE-ACS) with high risk at presentation. However, its role is not clear for patients stabilized with standard medical treatment but with a poor responsiveness to DAPT.\n\nIn this study, Investigators administered tirofiban on top of DAPT to patients with NSTE-ACS undergoing PCI who have a high platelet reactivity (HPR) identified by VerifyNow.\n\nTo the best of our knowledge, there are few studies conducted with tirofiban for tailored antiplatelet therapy. Moreover, this is the first randomized study with NSTE-ACS patients for tailored use of tirofiban under the guidance of platelet reactivity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed with NSTE-ACS who need PCI\n* loaded with aspirin and clopidogrel at least 6 h before the procedure\n\nExclusion Criteria:\n\n* thrombocytopenia (platelet count \\<100,000/μL)\n* history of hemorrhagic stroke\n* history of ischemic stroke in the recent 2 year\n* history of major surgery 6 months prior'}, 'identificationModule': {'nctId': 'NCT03114995', 'briefTitle': 'Tailored Use of Tirofiban for Non-ST-elevation Acute Coronary Syndrome Patients', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Effect of Tailored Use of Tirofiban in Patients With Non-ST-elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'B-1111-140-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (high platelet reactivity - tirofiban)', 'description': 'Patients with high platelet reactivity unit (230 or higher) Tirofiban administered dose: 0.4 μg/kg/min continuous infusion for 30 min and then 0.10 μg/kg/min continuous infusion for 12 h', 'interventionNames': ['Drug: Tirofiban']}, {'type': 'NO_INTERVENTION', 'label': 'Control C1 (high platelet reactivity - no tirofiban)', 'description': 'Patients with high platelet reactivity unit (230 or higher) Tirofiban was not administered'}, {'type': 'NO_INTERVENTION', 'label': 'Control C2 (low platelet reactivity - no tirofiban)', 'description': 'Patients with low platelet reactivity unit (less than 230) Tirofiban was not administered'}], 'interventions': [{'name': 'Tirofiban', 'type': 'DRUG', 'otherNames': ['Agrastat'], 'armGroupLabels': ['Group A (high platelet reactivity - tirofiban)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Tae-Jin Youn, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'not planned'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Cardiovascular Center', 'investigatorFullName': 'Tae-Jin Youn', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}