Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-02-21 @ 2:13 AM
Study NCT ID:
NCT03657758
Status:
UNKNOWN
Last Update Posted:
2018-09-18
First Post:
2018-08-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lesional Evaluation of High Risk Patients With Neoatherosclerosis Treated With Rosuvastatin and Eicosapentaenoic Acid Using Optical Coherence Tomography(OCT)[LINK IT TWO]
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D000787', 'term': 'Angina Pectoris'}], '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'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-09-17', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-16', 'studyFirstSubmitDate': '2018-08-31', 'studyFirstSubmitQcDate': '2018-09-04', 'lastUpdatePostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in lipid index', 'timeFrame': '9 months', 'description': 'mean lipid arc ✕ lipid length'}], 'secondaryOutcomes': [{'measure': 'MACE', 'timeFrame': '9 months', 'description': 'Major cerebro-cardiovascular events（Nonfatal stroke, Nonfatal myocardial infarction, cardiovascular death)'}, {'measure': 'The change in minimum lumen area', 'timeFrame': '9 months', 'description': 'OCT parameter'}, {'measure': 'The change in average neointimal thickness', 'timeFrame': '9 months', 'description': 'OCT parameter'}, {'measure': 'The change in lipid arc', 'timeFrame': '9 months', 'description': 'OCT parameter'}, {'measure': 'The change in lipid length', 'timeFrame': '9 months', 'description': 'OCT parameter'}, {'measure': 'The change in thin cap fibroatheroma', 'timeFrame': '9 months', 'description': 'OCT parameter'}, {'measure': 'The change in macrophage grade', 'timeFrame': '9 months', 'description': 'OCT parameter'}, {'measure': 'The change in plaque volume', 'timeFrame': '9 months', 'description': 'Near infrared spectroscopy intravascular ultrasound(NIRS-IVUS) parameter'}, {'measure': 'The change in max Lipid-core burden index', 'timeFrame': '9 months', 'description': 'NIRS-IVUS parameter'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['eicosapentaenoic acid', 'OCT', 'neoatherosclerosis'], 'conditions': ['Coronary Artery Disease', 'Angina Pectoris']}, 'descriptionModule': {'briefSummary': 'This study aim is to evaluate the additional effect of eicosapentaenoic acid and dose up effect of rosuvastatin for neoatherosclerosis in coronary artery disease patients.', 'detailedDescription': 'Eicosapentaenoic acid and statin therapy prevents cardiovascular events. However, the impact of these treatment in patients with in-stent neoatherosclerosis has not been clarified.\n\nSo, the investigators conducted LINK IT study. This study showed that eicosapentaenoic acid(EPA) and rosuvastatin therapy improve lipid index in patients compared with rosuvastatin alone therapy.\n\nHowever, it was insufficient to directly evaluate the efficacy of additional effect of EPA for neoatherosclerosis. Because, statin dose of two groups was different and type of stent was variety.\n\nTherefore, the investigators designed a new prospective, randomized OCT study. The OCT operators randomly assigned 75 patients who were detected neoatherosclerosis on follow-up OCT examination after implanted everolimus eluting stent to three groups; 5mg/day of rosuvastatin therapy (low dose statin therapy group) or 10mg/day of rosuvastatin therapy (high dose statin therapy group) or 10mg/day of rosuvastatin and 1800mg/day of eicosapentaenoic acid therapy (EPA and statin therapy group). Serial coronary angiography and OCT were performed at 9 months after baseline OCT procedure.\n\nThis study aim is to evaluate the additional effect of eicosapentaenoic acid and dose up effect of rosuvastatin for neoatherosclerosis in coronary artery disease patients by comparing 3 groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. over 20 years\n2. Patients implanted everolimus-eluting stent(EES) neoatherosccrelosis with neoatherosclerosis by OCT\n3. LDL is or less than 100 mg/dl after ingesting 5 mg/day of rosuvastatin\n\nExclusion Criteria:\n\n1. Patients taking omega 3 fatty acid before randomization\n2. Patients allergic to rosuvastatin or eicosapentaenoic acid\n3. Patients with a history of hemorrhagic stroke\n4. Patients taking anti cancer agent\n5. Patients undergoing LDL apheresis\n6. Patients with severe liver disease or severe kidney disease\n7. Patients who conflict with any of the warnings or contraindications listed in the domestic package insert of rosuvastatin\n8. Patients who conflict with any of the warnings or contraindications listed in the domestic package insert of eicosapentaenoic acid\n9. Patients performed percutaneous coronary intervention with restenosis of target lesion\n10. Pregnant women or patients with possibility of Pregnancy or nursing woman'}, 'identificationModule': {'nctId': 'NCT03657758', 'briefTitle': 'Lesional Evaluation of High Risk Patients With Neoatherosclerosis Treated With Rosuvastatin and Eicosapentaenoic Acid Using Optical Coherence Tomography(OCT)[LINK IT TWO]', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kobe University'}, 'officialTitle': 'Lesional Evaluation of High Risk Patients With Neoatherosclerosis Treated With Rosuvastatin and Eicosapentaenoic Acid Using OCT', 'orgStudyIdInfo': {'id': '300027'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'EPA and statin therapy group', 'description': 'After randomization, patients with combination therapy start EPA (1800mg/day) and high dose rosuvastatin (10mg/day) for ９ months.', 'interventionNames': ['Drug: EPA and rosuvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High dose statin therapy group', 'description': 'After randomization, patients with high dose statin therapy start high dose rosuvastatin (10mg/day) for ９ months.', 'interventionNames': ['Drug: High dose rosuvastatin']}, {'type': 'NO_INTERVENTION', 'label': 'low dose statin therapy group', 'description': 'After randomization, patients with low dose statin therapy take low dose rosuvastatin (5mg/day) for ９ months.'}], 'interventions': [{'name': 'EPA and rosuvastatin', 'type': 'DRUG', 'description': 'To take EPA (1800mg/day) and high dose rosuvastatin (10mg/day) for ９ months.', 'armGroupLabels': ['EPA and statin therapy group']}, {'name': 'High dose rosuvastatin', 'type': 'DRUG', 'description': 'To take high dose rosuvastatin (10mg/day) for ９ months.', 'armGroupLabels': ['High dose statin therapy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '650-0017', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'contacts': [{'name': 'Hiromasa Otake, ph.D', 'role': 'CONTACT', 'email': 'hotake@med.kobe-u.ac.jp', 'phone': '+81-78-382-5846'}], 'facility': 'Kobe University Graduate School of Medicine, Department of Cardiology', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}], 'centralContacts': [{'name': 'Hiromasa Otake, ph.D', 'role': 'CONTACT', 'email': 'hotake@med.kobe-u.ac.jp', 'phone': '+81-78-382-5846'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kobe University', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Lecturer', 'investigatorFullName': 'Hiromasa Otake', 'investigatorAffiliation': 'Kobe University'}}}}