Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-04-09 @ 1:23 AM
Study NCT ID:
NCT05418556
Status:
RECRUITING
Last Update Posted:
2024-08-27
First Post:
2022-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tailored Versus Coventional AntiPlaTelet Strategy Intended After OPTIMIZEd Drug Eluting Stent
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], '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': 'D001241', 'term': 'Aspirin'}, {'id': 'D000077144', 'term': 'Clopidogrel'}, {'id': 'D000068799', 'term': 'Prasugrel Hydrochloride'}, {'id': 'D000077486', 'term': 'Ticagrelor'}], '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': 'D010879', 'term': 'Piperazines'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '* Eligible subjects will be randomized 1:1 to a) conventional DAPT strategy or b) tailored anti-platelet strategy (short DAPT followed by P2Y12 inhibitor alone) after optimized DES implantation guided by intravascular imaging.\n* All subjects will be clinically followed at 1, 6, and 12 months'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3944}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-26', 'studyFirstSubmitDate': '2022-06-07', 'studyFirstSubmitQcDate': '2022-06-12', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1) clinically relevant bleeding [Bleeding Academic Research Consortium (BARC) 2, 3, or 5]', 'timeFrame': '12 month', 'description': '1\\) clinically relevant bleeding \\[Bleeding Academic Research Consortium (BARC) 2, 3, or 5\\]'}, {'measure': '2) net clinical outcome defined as a composite of all-cause death, MI, ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST), and clinically relevant bleeding [BARC 2, 3, or 5]', 'timeFrame': '12 month', 'description': '2\\) net clinical outcome defined as a composite of all-cause death, MI, ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST), and clinically relevant bleeding \\[BARC 2, 3, or 5\\]'}, {'measure': '3) ischemic composite adverse event of all-cause death, MI, ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST)', 'timeFrame': '12 month', 'description': '3\\) ischemic composite adverse event of all-cause death, MI, ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST)'}], 'secondaryOutcomes': [{'measure': '1) Major or minor bleeding according to definitions from TIMI and International Society of Thrombosis or Hemostasis (ISTH)', 'timeFrame': '12 month', 'description': '1\\) Major or minor bleeding according to definitions from TIMI and International Society of Thrombosis or Hemostasis (ISTH)'}, {'measure': '2) % difference of strut coverage on FU OCT between optimal vs. suboptimal DES implantation group', 'timeFrame': '1 or 3 month', 'description': '2\\) % difference of strut coverage on FU OCT between optimal vs. suboptimal DES implantation group'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Objectives: To assess the safety of tailored antiplatelet therapy (short DAPT followed by P2Y12 inhibitor alone strategy) in patients who received optimized DES implantation guided by intravascular imaging (IVUS or OCT)\n\nHypothesis: Tailored antiplatelet strategy (short DAPT followed by P2Y12 inhibitor alone) is superior to conventional antiplatelet strategy in terms of clinically relevant bleeding and noninferior for ischemic composite adverse events in patients who received intravascular imaging-guided optimized DES implantation. (Optimized stent evaluated by on-site IVUS/OCT could act as an essential criterion for decision making for tailored antithrombotic strategy)', 'detailedDescription': 'Objective: To assess the safety of tailored antiplatelet strategy (short DAPT followed by P2Y12 inhibitor alone) in patients who received optimized DES implantation guided by intravascular imaging (IVUS or OCT)\n\nDesign: Prospective, open label, multi-center, dual arm, randomized trial Number of Subjects 3,944 subjects (1972:1972) Study Population: Patients with coronary artery disease undergoing imaging-guided PCI\n\nStudy Design:\n\n* Eligible subjects will be randomized 1:1 to a) conventional DAPT strategy or b) tailored anti-platelet strategy (short DAPT followed by P2Y12 inhibitor alone) after optimized DES implantation guided by intravascular imaging.\n* All subjects will be clinically followed at 1, 6, and 12 months\n\nCo-primary Endpoints:\n\n1. Clinically relevant bleeding (BARC 2, 3, or 5) at 12 months post-PCI\n2. Ischemic composite adverse events of all-cause death, MI, ischemia-driven TVR, stent thrombosis at 12 months post-PCI\n3. Net clinical outcome (NACE) of all-cause death, MI, ischemia-driven TVR, stent thrombosis, BARC 2,3,5 bleeding at 12 months post-PCI\n\nStatistics and Analysis: The study was designed to test the hypothesis that tailored antithrombotic strategy, as compared to the conventional DAPT, would be superior for clinically relevant bleeding, noninferior to the ischemic composite adverse events and NACE. The primary analysis would be evaluated by intention-to-treat analysis. With 3756 (each 1,878) patients, this study has \\>80% power to detect noninferiority of tailored antiplatelet strategy for ischemic composite adverse event, \\>85% power to detect noninferiority of tailored antiplatelet strategy for NACE, and \\>85% power to detect superiority of the tailored antiplatelet arm on clinically relevant bleeding. To compensate for 5% attrition rate, 3,944 (each 1,972) patients will be randomized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Men or women ≥19 years\n2. Typical chest pain or objective evidence of myocardial ischemia suitable for PCI\n3. Significant de novo coronary artery lesions suitable for DES implantation\n4. Patients who underwent optimized stent implantation either by IVUS or OCT\n\n * Using IVUS\n\n * MSA \\>5.5 mm2, or MSA \\>90% of the MLA at the distal reference segment\n * Plaque burden \\<50% with 5 mm of both stent edge\n * No edge dissection, thrombus or plaque protrusion/stent area \\<10%\n * Using OCT\n\n * MSA \\>4.5 mm2, or MSA \\>90% of the MLA at the distal reference segment\n * No significant malapposition\n * No significant edge dissection, thrombus or plaque protrusion/stent area \\<10%\n5. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site\n\nExclusion Criteria:\n\n1. Angiographic exclusion criteria: any of the followings 1. Bypass graft lesions 2. Lesions in which impaired delivery of imaging catheters is expected:\n\n * Extreme angulation (≥90°) proximal to or within the target lesion.\n * Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.\n * Heavy calcification proximal to or within the target lesion.\n2. In-stent restenosis\n3. Hypersensitivity or contraindication to device material and its degradants and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated.\n4. Persistent thrombocytopenia (platelet count \\<80,000/l)\n5. Any history of hemorrhagic stroke or intracranial hemorrhage / TIA or ischemic stroke within the past 6 months\n6. A known intolerance or hypersensitivity to a study drug (aspirin, clopidogrel or ticagrelor) or heparin\n7. Patients requiring long-term oral anticoagulants or cilostazol\n8. Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure.\n9. A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer.\n10. Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.\n11. History of liver cirrhosis (Child-Pugh B or C) or biliary tract obstruction\n12. Life expectancy \\< 1 years for any non-cardiac or cardiac causes\n13. Cardiogenic shock at the index admission\n14. Patient's pregnant or breast-feeding\n15. Active bleeding or extreme-risk for major bleeding (e.g. active peptic ulcer disease, gastrointestinal pathology with a high risk for bleeding, malignancies with a high risk for bleeding)\n16. Unwillingness or inability to comply with the procedures described in this protocol."}, 'identificationModule': {'nctId': 'NCT05418556', 'acronym': 'OPTIMIZE-APT', 'briefTitle': 'Tailored Versus Coventional AntiPlaTelet Strategy Intended After OPTIMIZEd Drug Eluting Stent', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Tailored Versus Coventional AntiPlaTelet Strategy Intended After OPTIMIZEd Drug', 'orgStudyIdInfo': {'id': '2022-0568'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Arm', 'description': 'After PCI, patients are prescribed aspirin at a daily dose of 100 mg PO plus a P2Y12 inhibitor \\[clopidogrel or ticagrelor or prasugrel according to the clinical diagnosis\\] for 12 months after the index PCI.', 'interventionNames': ['Drug: aspirin']}, {'type': 'EXPERIMENTAL', 'label': 'Tailored Arm', 'description': 'The antiplatelet regimens post-PCI are 1-month DAPT (aspirin plus clopidogrel) followed by 11-months clopidogrel alone for CCS, and 3-months DAPT (aspirin plus P2Y12 inhibitor \\[ticagrelor, prasugrel\\]) followed by 9-months P2Y12 inhibitor alone for ACS.', 'interventionNames': ['Drug: aspirin']}], 'interventions': [{'name': 'aspirin', 'type': 'DRUG', 'otherNames': ['clopidogrel', 'prasugrel', 'ticagrelor'], 'description': 'DAPT strategy', 'armGroupLabels': ['Conventional Arm', 'Tailored Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bucheon-si', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ha Wook Park, MD', 'role': 'CONTACT'}, {'name': 'Ha Wook Park, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bucheon Sejong Hospital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yong Rak Cho, MD', 'role': 'CONTACT'}, {'name': 'Yong Rak Cho, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dong-A University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Busan', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Tae Hyun Yang, MD', 'role': 'CONTACT'}, {'name': 'Tae Hyun Yang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Inje University Busan Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jeong Ho Heo, MD', 'role': 'CONTACT'}, {'name': 'Jeong Ho Heo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kosin University Gospel Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Changwon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jae Seok Bae, MD', 'role': 'CONTACT'}, {'name': 'Jae Seok Bae, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gyeongsang National University Changwon Hospital', 'geoPoint': {'lat': 35.22806, 'lon': 128.68111}}, {'city': 'Chuncheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Bong Ki Lee, MD', 'role': 'CONTACT'}, {'name': 'Bong Ki Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kangwon National University Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'city': 'Chungju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang Min Kim, MD', 'role': 'CONTACT'}, {'name': 'Sang Min Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chungbuk National University Hospital', 'geoPoint': {'lat': 36.97666, 'lon': 127.9287}}, {'city': 'Daegu', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jin Bae Lee, MD', 'role': 'CONTACT'}, {'name': 'Jin Bae Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Daegu Catholic Univ Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seung Ho Hur, MD', 'role': 'CONTACT'}, {'name': 'Seung Ho Hur, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Keimyung University Dongsan Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'NAM KYUN KIM, MD', 'role': 'CONTACT'}, {'name': 'Nam kyun Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang Wook Kang, MD', 'role': 'CONTACT'}, {'name': 'Sang Wook Kang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Veterans Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Gangneung', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Han Bit Park, MD', 'role': 'CONTACT'}, {'name': 'Han Bit Park, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gangneung Asan Hospital', 'geoPoint': {'lat': 37.75266, 'lon': 128.87239}}, {'city': 'Jeonju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang Rok Lee, MD', 'role': 'CONTACT'}, {'name': 'Sang Rok Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jeonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'city': 'Jinju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jin Sin Koh, MD', 'role': 'CONTACT'}, {'name': 'Jin Sin Koh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gyeongsang National University Hospital', 'geoPoint': {'lat': 35.19278, 'lon': 128.08472}}, {'city': 'Jungnam', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jae Hwan Lee, MD', 'role': 'CONTACT'}, {'name': 'Jae Hwan Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chungnam National University Sejong Hospital', 'geoPoint': {'lat': 36.27333, 'lon': 128.02522}}, {'city': 'Jungnam', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'tae soo kang, MD', 'role': 'CONTACT'}, {'name': 'tae soo kang, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Dankook University Hospital', 'geoPoint': {'lat': 36.27333, 'lon': 128.02522}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Pil Hyung Lee, MD', 'role': 'CONTACT', 'email': 'pilmo11@hanmail.net'}, {'name': 'Seung-Whan Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Pil Hyung Lee, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tae Oh Kim, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jong Young Lee, MD', 'role': 'CONTACT'}, {'name': 'Jong Young Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kangbuk Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Soon Jun Hong, MD', 'role': 'CONTACT'}, {'name': 'Soon Jun Hong, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Pum Joon Kim, MD', 'role': 'CONTACT'}, {'name': 'Pum Joon Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "The Catholic University of Korea, Eunpyeong St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Chang Hoon Lee, MD', 'role': 'CONTACT'}, {'name': 'Chang Hoon Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Veterans Hospital Service Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Suwon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Myeong Ho Yoon, MD', 'role': 'CONTACT'}, {'name': 'Myeong Ho Yoon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'city': 'Suwon', 'status': 'COMPLETED', 'country': 'South Korea', 'facility': "The Catholic University of Korea, ST. Vincent's Hospital", 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'city': 'Ulsan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Gyung Min Park, MD', 'role': 'CONTACT'}, {'name': 'Gyung Min Park, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ulsan University Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}, {'city': 'Yangsan', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kook Jin Chun, MD', 'role': 'CONTACT'}, {'name': 'Kook Jin Chun, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}], 'centralContacts': [{'name': 'Ji Sue Hong, RN', 'role': 'CONTACT', 'email': 'sue5165@naver.com', 'phone': '82 2-2045-3798'}, {'name': 'Pil Hyung Lee, MD', 'role': 'CONTACT', 'email': 'pilmo11@hanmail.net', 'phone': '82 2-3010-3170'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Part of Cardiology, Principal Investigator, associate professor', 'investigatorFullName': 'Seung-Whan Lee, M.D., Ph.D.', 'investigatorAffiliation': 'Asan Medical Center'}}}}