Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT04072705
Status:
COMPLETED
Last Update Posted:
2023-09-25
First Post:
2019-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clopidogrel Preventive Effect Based on CYP2C19 Genotype in Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Cytochrome P450 2C19 genotype'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2927}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-22', 'studyFirstSubmitDate': '2019-08-25', 'studyFirstSubmitQcDate': '2019-08-27', 'lastUpdatePostDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of major adverse events', 'timeFrame': 'Tile frame: participants will be followed at 0, 1, 3, 6 months', 'description': 'Occurrence of major bleeding (fatal bleeding, symptomatic cerebral hemorrhage, ocular hemorrhage, bleeding which needs absolute bed rest or hospitalization or transfusion (more than 2 pack of whole blood or RBC).\n\nOccurrence of all-causes mortality'}], 'primaryOutcomes': [{'measure': 'composite cardiovascular events', 'timeFrame': 'up to 6 months', 'description': 'Occurrence of composite cardiovascular events (recurrent stroke, myocardial infarction, cardiovascular death)'}], 'secondaryOutcomes': [{'measure': 'cardiovascular events', 'timeFrame': 'up to 6 months', 'description': 'Occurrence of ischemic stroke'}, {'measure': 'cardiovascular events', 'timeFrame': 'up to 6 months', 'description': 'Occurrence of transient ischemic attack'}, {'measure': 'cardiovascular events', 'timeFrame': 'up to 6 months', 'description': 'Revascularization of cerebral, coronary, peripheral artery or aorta'}, {'measure': 'cardiovascular events', 'timeFrame': 'up to 6 months', 'description': 'Occurrence of myocardial infarction'}, {'measure': 'early neurological worsening', 'timeFrame': 'up to 7 days', 'description': 'increased National Institutes of Health Stroke Scale within 7 day after admission)'}, {'measure': 'Prognosis', 'timeFrame': '3 months', 'description': 'ratio of modified Rankin scale (0 - 2) at 3 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pharmacogenetics', 'Cytochrome P450 2C19', 'Clopidogrel', 'Stroke'], 'conditions': ['Acute Ischemic Stroke']}, 'referencesModule': {'references': [{'pmid': '15023882', 'type': 'BACKGROUND', 'citation': 'Mitsios JV, Papathanasiou AI, Rodis FI, Elisaf M, Goudevenos JA, Tselepis AD. Atorvastatin does not affect the antiplatelet potency of clopidogrel when it is administered concomitantly for 5 weeks in patients with acute coronary syndromes. Circulation. 2004 Mar 23;109(11):1335-8. doi: 10.1161/01.CIR.0000124581.18191.15. Epub 2004 Mar 15.'}, {'pmid': '12515739', 'type': 'BACKGROUND', 'citation': 'Lau WC, Waskell LA, Watkins PB, Neer CJ, Horowitz K, Hopp AS, Tait AR, Carville DG, Guyer KE, Bates ER. Atorvastatin reduces the ability of clopidogrel to inhibit platelet aggregation: a new drug-drug interaction. Circulation. 2003 Jan 7;107(1):32-7. doi: 10.1161/01.cir.0000047060.60595.cc.'}, {'pmid': '15837243', 'type': 'BACKGROUND', 'citation': 'Nguyen TA, Diodati JG, Pharand C. Resistance to clopidogrel: a review of the evidence. J Am Coll Cardiol. 2005 Apr 19;45(8):1157-64. doi: 10.1016/j.jacc.2005.01.034.'}, {'pmid': '19106084', 'type': 'BACKGROUND', 'citation': 'Mega JL, Close SL, Wiviott SD, Shen L, Hockett RD, Brandt JT, Walker JR, Antman EM, Macias W, Braunwald E, Sabatine MS. Cytochrome p-450 polymorphisms and response to clopidogrel. N Engl J Med. 2009 Jan 22;360(4):354-62. doi: 10.1056/NEJMoa0809171. Epub 2008 Dec 22.'}, {'pmid': '19106083', 'type': 'BACKGROUND', 'citation': 'Simon T, Verstuyft C, Mary-Krause M, Quteineh L, Drouet E, Meneveau N, Steg PG, Ferrieres J, Danchin N, Becquemont L; French Registry of Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction (FAST-MI) Investigators. Genetic determinants of response to clopidogrel and cardiovascular events. N Engl J Med. 2009 Jan 22;360(4):363-75. doi: 10.1056/NEJMoa0808227. Epub 2008 Dec 22.'}, {'pmid': '19108880', 'type': 'BACKGROUND', 'citation': 'Collet JP, Hulot JS, Pena A, Villard E, Esteve JB, Silvain J, Payot L, Brugier D, Cayla G, Beygui F, Bensimon G, Funck-Brentano C, Montalescot G. Cytochrome P450 2C19 polymorphism in young patients treated with clopidogrel after myocardial infarction: a cohort study. Lancet. 2009 Jan 24;373(9660):309-17. doi: 10.1016/S0140-6736(08)61845-0. Epub 2008 Dec 26.'}, {'pmid': '19706858', 'type': 'BACKGROUND', 'citation': "Shuldiner AR, O'Connell JR, Bliden KP, Gandhi A, Ryan K, Horenstein RB, Damcott CM, Pakyz R, Tantry US, Gibson Q, Pollin TI, Post W, Parsa A, Mitchell BD, Faraday N, Herzog W, Gurbel PA. Association of cytochrome P450 2C19 genotype with the antiplatelet effect and clinical efficacy of clopidogrel therapy. JAMA. 2009 Aug 26;302(8):849-57. doi: 10.1001/jama.2009.1232."}, {'pmid': '27806998', 'type': 'BACKGROUND', 'citation': 'Pan Y, Chen W, Xu Y, Yi X, Han Y, Yang Q, Li X, Huang L, Johnston SC, Zhao X, Liu L, Zhang Q, Wang G, Wang Y, Wang Y. Genetic Polymorphisms and Clopidogrel Efficacy for Acute Ischemic Stroke or Transient Ischemic Attack: A Systematic Review and Meta-Analysis. Circulation. 2017 Jan 3;135(1):21-33. doi: 10.1161/CIRCULATIONAHA.116.024913. Epub 2016 Nov 2.'}, {'pmid': '29037010', 'type': 'BACKGROUND', 'citation': 'Han SW, Kim YJ, Ahn SH, Seo WK, Yu S, Oh SH, Nam HS, Choi HY, Yoon SS, Kim SH, Lee JY, Lee JH, Hwang YH, Lee KO, Jung YH, Lee J, Sohn SI, Kim YN, Lee KA, Bushnell CD, Lee KY. Effects of Triflusal and Clopidogrel on the Secondary Prevention of Stroke Based on Cytochrome P450 2C19 Genotyping. J Stroke. 2017 Sep;19(3):356-364. doi: 10.5853/jos.2017.01249. Epub 2017 Sep 29.'}, {'pmid': '17667801', 'type': 'BACKGROUND', 'citation': 'Lee SS, Lee SJ, Gwak J, Jung HJ, Thi-Le H, Song IS, Kim EY, Shin JG. Comparisons of CYP2C19 genetic polymorphisms between Korean and Vietnamese populations. Ther Drug Monit. 2007 Aug;29(4):455-9. doi: 10.1097/FTD.0b013e31811f383c.'}, {'pmid': '27348249', 'type': 'BACKGROUND', 'citation': 'Wang Y, Zhao X, Lin J, Li H, Johnston SC, Lin Y, Pan Y, Liu L, Wang D, Wang C, Meng X, Xu J, Wang Y; CHANCE investigators. Association Between CYP2C19 Loss-of-Function Allele Status and Efficacy of Clopidogrel for Risk Reduction Among Patients With Minor Stroke or Transient Ischemic Attack. JAMA. 2016 Jul 5;316(1):70-8. doi: 10.1001/jama.2016.8662.'}, {'pmid': '8918275', 'type': 'BACKGROUND', 'citation': 'CAPRIE Steering Committee. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). CAPRIE Steering Committee. Lancet. 1996 Nov 16;348(9038):1329-39. doi: 10.1016/s0140-6736(96)09457-3.'}, {'pmid': '40184070', 'type': 'DERIVED', 'citation': 'Jung YH, Song TJ, Kim J, Park HK, Han SW, Kim YD, Park JH, Cha JK, Park HY, Sohn SI, Yu S, Lee JH, Shin DH, Kim EG, Lee HS, Lee KY; PLATELET Trial Investigators. Cytochrome P450 2C19 Genotypes and Clopidogrel in Patients With Ischemic Stroke: A Nonrandomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e250398. doi: 10.1001/jamanetworkopen.2025.0398.'}, {'pmid': '32759249', 'type': 'DERIVED', 'citation': 'Song TJ, Kim J, Han SW, Kim YD, Lee JY, Ahn SH, Lee HS, Jung YH, Lee KY. Clopidogrel preventive effect based on cytochrome P450 2C19 genotype in ischaemic stroke: protocol for multicentre observational study. BMJ Open. 2020 Aug 5;10(8):e038031. doi: 10.1136/bmjopen-2020-038031.'}]}, 'descriptionModule': {'briefSummary': 'The hypothesis of this study is that "the poor metabolizer or intermediate metabolizer of the cytochrome P450 2C19 genotype in patients with acute ischemic stroke is associated with increased risk of composite cardiovascular events (recurrent stroke, myocardial infarction, cardiovascular death) compared to those who of extensive metabolizer of the cytochrome P450 2C19 genotype".', 'detailedDescription': 'Clopidogrel, one of the antiplatelet agents used for secondary prevention in patients with ischemic stroke and coronary artery disease, has been shown to have a superior antiplatelet effect compared to aspirin, and is therefore being administered to many patients with stroke and coronary artery disease. Clopidogrel inhibits platelet-derived ADP receptor, P2Y12, in the liver to produce an anti-platelet effect. It has been suggested that clopidogrel resistance could be occurred from drug-drug interaction via the same pharmacological metabolic pathway. Previous studies reported that the genotypes of Cytochrome P450 2C19, which is involved in the metabolism of clopidogrel in the liver, lead to differences in drug response and recurrence rates of cardiovascular disease. The risk of recurrence of ischemic stroke was reported to be about 4 times higher in patients with a poor metabolizer or intermediate metabolizer genotype of the Cytochrome P450 2C19 genotype compared to the extensive metabolizer genotype. This genotypes of Cytochrome P450 2C19 were also different according to race.\n\nThe researches about cytochrome P450 2C19 genotype and clopidogrel resistance have been conducted mainly in patients with coronary artery disease and are not known in stroke patients. Few studies have examined whether the resistance of clopidogrel according to the genotype of cytochrome P450 2C19 in stroke patients is related to the occurrence and/or recurrence of cardiovascular disease. The hypothesis of this study is that "the poor metabolizer or intermediate metabolizer of the cytochrome P450 2C19 genotype in patients with acute ischemic stroke is associated with increased risk of cardiovascular disease and mortality compared to those who of extensive metabolizer of the cytochrome P450 2C19 genotype".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute ischemic stroke who received clopidogrel 75 mg to 300 mg (in the case of loading dose) within 24 hours of symptom onset and who underwent Cytochrome P450 2C19 genotyping test', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ischemic stroke confirmed by brain CT or MRI\n2. Patient who received clopidogrel within 72 hours after onset of ischemic stroke\n3. Adults over 19 years\n4. Patients who agreed to participate in this study within 7 days after ischemic stroke\n5. Patients who underwent Cytochrome P450 2C19 genotype test.\n\nExclusion Criteria:\n\n1. Patients who currently take anticoagulation or is expected to take anticoagulation with 6 months from the screening date\n2. Patients who need other antiplatelet drugs except aspirin and clopidogrel\n3. Patients who were taking clopidogrel prior to ischemic stroke\n4. Patients scheduled for coronary artery stenting, coronary artery bypass surgery, carotid endarterectomy, carotid and cerebral artery stenting\n5. Patients with severe comorbidities or active cancer with an estimated life expectancy of less than two years\n6. Patients who participated in other drug clinical trials within the past 30 days\n7. Patients with high risk source of potential cardiac source of embolism in TOAST classification\n8. Patients who are expected to unable to participate or continue the study'}, 'identificationModule': {'nctId': 'NCT04072705', 'briefTitle': 'Clopidogrel Preventive Effect Based on CYP2C19 Genotype in Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Gangnam Severance Hospital'}, 'officialTitle': 'A Multicenter Prospective observationaL Study to evAluate the effecT of Clopidogrel on the prEvention of Major vascuLar Events According to the gEnotype of Cytochrome P450 2C19 in Ischemic Stroke paTients; PLATELET Study', 'orgStudyIdInfo': {'id': '3-2019-0195'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1. Poor and intermediate metabolizer group', 'description': 'Poor and intermediate metabolizer group: acute ischemic stroke patients with poor and intermediate metabolizer genotype of cytochrome P450 2C19 for clopidogrel.', 'interventionNames': ['Drug: General principles of care and judgement of researcher']}, {'label': '2. Extensive metabolizer group', 'description': 'Extensive metabolizer group: acute ischemic stroke patients with Extensive metabolizer genotype of cytochrome P450 2C19 for clopidogrel.', 'interventionNames': ['Drug: General principles of care and judgement of researcher']}], 'interventions': [{'name': 'General principles of care and judgement of researcher', 'type': 'DRUG', 'description': 'Because our study will be performed by observational design, there will be no intervention for our study. Because it is a registry-based study, overall decision making for medications will be performed according to the general principles of care and judgement of researcher.', 'armGroupLabels': ['1. Poor and intermediate metabolizer group', '2. Extensive metabolizer group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16995', 'city': 'Yongin-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Yongin Severance Hospital', 'geoPoint': {'lat': 37.29686, 'lon': 127.08042}}, {'zip': '15355', 'city': 'Ansan', 'country': 'South Korea', 'facility': 'Department of Neurology Korea University Ansan Hospital', 'geoPoint': {'lat': 36.8741, 'lon': 126.2116}}, {'zip': '14068', 'city': 'Anyang', 'country': 'South Korea', 'facility': 'Department of Neurology Hallym University Sacred Heart Hospital', 'geoPoint': {'lat': 36.9577, 'lon': 127.1464}}, {'zip': '47392', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Department of Neurology Inje University Busan Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '49201', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Department of Neurology Dong-A University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '49267', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Department of Neurology Kosin University Gospel Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '51394', 'city': 'Changwon', 'country': 'South Korea', 'facility': 'Department of Neurology Changwon Fatima Hospital', 'geoPoint': {'lat': 35.22806, 'lon': 128.68111}}, {'zip': '24253', 'city': 'Chuncheon', 'country': 'South Korea', 'facility': 'Department of Neurology Hallym University Chuncheon Sacred Heart Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'zip': '24289', 'city': 'Chuncheon', 'country': 'South Korea', 'facility': 'Department of Neurology Kangwon National University Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'zip': '41931', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Department of Neurology Keimyung University Dongsan Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '41944', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Department of Neurology Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '35233', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Department of Neurology Daejeon Eulji Medical Center Eulji University', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '10099', 'city': 'Gimpo-si', 'country': 'South Korea', 'facility': 'Department of Neurology Gimpo Woori Hospital', 'geoPoint': {'lat': 37.62361, 'lon': 126.71417}}, {'zip': '10444', 'city': 'Goyang', 'country': 'South Korea', 'facility': 'Department of Neurology National Health Insurance Service Ilsan Hospital', 'geoPoint': {'lat': 36.21689, 'lon': 127.19731}}, {'zip': '10475', 'city': 'Goyang', 'country': 'South Korea', 'facility': 'Department of Neurology Myongji Hospital', 'geoPoint': {'lat': 36.21689, 'lon': 127.19731}}, {'zip': '61453', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Department of Neurology Chosun University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '61469', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Department of Neurology Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '18450', 'city': 'Hwaseong-si', 'country': 'South Korea', 'facility': 'Department of Neurology Hallym University Dongtan Sacred Heart Hospital', 'geoPoint': {'lat': 37.20682, 'lon': 126.8169}}, {'zip': '54538', 'city': 'Iksan', 'country': 'South Korea', 'facility': 'Department of Neurology Wonkwang University Hospital', 'geoPoint': {'lat': 35.94389, 'lon': 126.95444}}, {'zip': '21565', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Department of Neurology Gachon University Gil Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '22332', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Department of Neurology Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '22711', 'city': 'Incheon', 'country': 'South Korea', 'facility': "Department of Neurology Catholic Kwandong University International St.Mary's Hospital", 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '13620', 'city': 'Seongnam', 'country': 'South Korea', 'facility': 'Department of Neurology Seoul National University Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'zip': '01757', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Neurology Inje University Sanggye Paik Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '02053', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Neurology Seoul Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '02447', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Neurology KyungHee University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '02841', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Neurology Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Neurology Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Neurology Severance Hospital, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '04564', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Neurology National Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '04763', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Neurology Hanyang University Seoul Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05278', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Neurology KyungHee University Hospital at Gangdong', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05355', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Neurology Kangdong Sacred Heart Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06273', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Neurology, Gangnam Severance Hospital, Yonsei Univ. College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06973', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Neurology Chung-Ang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07804', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Neurology Ewha Womans University Seoul Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08308', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Neurology Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'KyungYul Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gangnam Severance Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gangnam Severance Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'SAMJIN PHARM', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'KyungYul Lee, Professor', 'investigatorFullName': 'Kyung-Yul Lee', 'investigatorAffiliation': 'Gangnam Severance Hospital'}}}}